Celebrate Columbus Day! Register for Pharma and Healthcare Events Thru Monday and Save $300!

Register for any of the following IIR events and receive a $300 discount*

Mention code COLUMBUSLI when registering for each/any of the following:

-  Register here for IIR’s 15^th Annual Business of Biosimilars event taking place October 20-22, 2014 in Boston, MA, visit the website for full details.

-  Register here for IIR’s 15^th Annual Immunogenicity and Biotherapeutics event taking place October 20-22, 2014 in Boston, MA, visitthe website for full details.

-  Register here for IIR’s 10^th Annual Bioassays and Bioanalytical Method Development event taking place October 20-22, 2014 in Boston, MA, visit the websitefor full details.

Have any questions? E-mail Jennifer Pereira.

*This promotion is only valid October 10^th-13^th 2014. Offer cannot be applied retroactively to confirmed paying registrants and cannot be combined with any other discounts or promotions. All registrants and guests are subject to IIR approval.

Share this article with your social network, just click below to share now!

Share |

Merck KGaA to Further Biosimilar Investment

Merck KGaA announced plans today keeping the group on track for its “Fit for 2018” plan for growth and transformation.  Part of those plans include an additional $165 - $190 million investment in biosimilars for 2015.  Ultimately, that exact number is dependent on the outcome of certain Phase I trials that are currently ongoing.  That, of course, is in addition the $128 million the German company has set aside for biosimilars this year.

In addition, the company plans to expand on existing partnerships with India’s Dr. Reddy’s and Brazil’s Bionovis with an in-licensing agreement for a late-stage biosimilar.  Initially, the drug will be intended for smaller, emerging markets.  Between 2015 and 2016, Merck plans to initiate anywhere from two to five Phase III clinical trials. 

The release also noted some internal shuffle within Merck.  Stefan Oschmann has been promoted to deputy CEO and Vice Chairman of the executive board while Belén Garijo will move up to the executive board and head the pharma business. 

The full press release can be found here.

We’ll have more on the latest developments in the biosimilars market at the 15^thAnnual Business of Biosimilars meeting. Join us October 20-22 in Boston, MA. Download the agenda to see what’s on tap.

                                                                                                     

SAVE $100.  Register here and use code XP1986BLOG.

Follow us on Twitter: @FutureOfBiopharma & @Biosimilars
Join us on LinkedIn

Share this article with your social network, just click below to share now!

Share |

Hospira Joins Business of Biosimilars, Last Chance to Save is This Friday

At this year's 15th Annual Business of Biosimilars Conference, partner with 100+ movers and shakers in the biosimilars space including pharma, biotech, and legal experts at the leading forum to drive commercialization and market access of biosimilar drugs. By attending, you will learn how to:

• Identify business opportunities by analyzing the commercial realities of the market
• Increase market access by expanding your global footprint in the US, EU, and emerging regions via a new "Around the World in One Day" workshop
• Gain clarity from legal experts on state substitution laws, interchangeability, and takeways of high profile court cases
• Navigate through regulatory complexities, maximize market uptake, and drive commercial success of a biosimilar drug

Plus! We're excited to announce that Mohamed H. Ladha, Global Biologics Marketing, Global Pharmaceutical Marketing, Hospira has joined the Biosimilars speaker faculty. Hear from him and other industry experts in the below panel:

Looking at the Commercial Realities of the Biosimilar Market

• •  
  Moderator: John J. Lewis, Senior Vice President, Policy & Public Affairs,           Association of Clinical Research Organizations
• •  
  Panelists:
• - Giles Somers, Lead Analyst, Generics and Biosimilars, Datamonitor
• - Carsten Brockmeyer, CEO, Formycon AG
• - Mohamed H. Ladha, Global Biologics Marketing, Global Pharmaceutical Marketing, Hospira

Don't miss out on the opportunity to gain a 360 degree view on regulatory complexities, policy adoption, globalization and commercialization of the biosimilars industry. Download the brochure today to see how you can capitalize on the expected growth in the biologic medicines market.

Don't forget! This Friday, 9/12 is your last chance to SAVE $200! PLUS, you can save an extra $100 as a reader of this blog for a total of $300.  Register here and use code XP1986BLOG.

Follow us on Twitter: @FutureOfBiopharma & @Biosimilars
Join us on LinkedIn

Share this article with your social network, just click below to share now!

Share |

FDA Establishes New "Purple Book" for Biosimilars

It may not make the New York Times’ Best Seller List, but the release of the FDA’s new book is certainly noteworthy.  The FDA today announced that they’ve published their first ever edition of the “Purple Book”, a list of licensed biological products and interchangeable biosimilars. 

The organization’s new list will serve a similar role to that of its counterpart in the pharmaceutical industry, the Orange Book, and will look to answer questions around the substitutability of products.  Many have voiced concerns over the extent to which biologics and biosimilars will be used interchangeably.  Although aimed to replicate the biologics they’re designed after, biosimilars are not identical to those drugs and therefore are not necessarily perfect substitutes in all cases.

The FDA has indicated that they will use a four part scale to categorize the interchangeability: 

•       •  Not similar
•       •  Similar
•       •  Highly similar
•       •  Highly similar with a fingerprint-like similarity

The book is broken up into two sections—biologic products regulated by the Center for Drug Evaluation and Research (CDER) and those regulated by the Center for Biologics Evaluation and Research (CBER). Among the information included in these lists is the date a biologic was licensed, the product name, the proprietary name and the BLA number. 

As we begin to see biosimilar applications roll in, we may see this list build out rather quickly over the next few years. 

You can find the announcement from the FDA here.

We’ll have more on the latest developments in the biosimilars market at the 15^thAnnual Business of Biosimilars meeting. Join us October 20-22 in Boston, MA. Download the agenda to see what’s on tap.

                                                                                                     

SAVE $100.  Register here and use code XP1986BLOG.

Follow us on Twitter: @FutureOfBiopharma & @Biosimilars
Join us on LinkedIn

Share this article with your social network, just click below to share now!

Share |

Biosimilars: Seven Cold Hard Facts

On July 24^th the FDA accepted its first application for a biosimilar drug in the U.S. and put the industry on alert that this new market is fast approaching.   While no one knows exactly when the first approval will come, here are a few facts to bring you up to speed for when it does: 

·      •  Estimates on savings attributed to biosimilars range from $42 - $108 billion over the first ten years of the market.

      •  The value of biologics slated to come off patent by 2017 is about $70 billion.

•  Per the Rheumatology Network, over the span of their lifetime, many drugs approved in the US and EU have eventually become “biosimilars” of themselves.  This is due to a “natural drift” in drug properties caused by changes in production such as using different batches of medium or manufacture at different sites.

        •  Recently, a group of 19 investors representing nearly $430 billion in assets  commended Novartis and Amgen for supporting a set of investor principles to guide boards on activities related to biosimilars. 

    •  A survey conducted among senior’s organization RetireSafe shows that 92% were unaware that the Affordable Care Act potentially allows for biosimilar drugs to be substituted for a biologic.  Furthermore, this could potentially be done without the patient or doctor being aware.

•  Hospira is looking to file its first biosimilar in the US within twelve months and currently has an R&D pipeline valued at around $40 billion.  

•  Amgen is developing a portfolio of biosimilars of which three are slated to launch in 2017.   

We’ll have more on the latest developments in the biosimilars market at the 15^th Annual Business of Biosimilars meeting. Join us October 20-22 in Boston, MA.  Download the agenda to see what’s on tap.

SAVE $100.  Register here and use code XP1986BLOG.

Follow us on Twitter: @FutureOfBiopharma & @Biosimilars
Join us on LinkedIn

Share this article with your social network, just click below to share now!

Share |

Doctors Take Sides on Biosimilar Naming Issue

Doctors have officially taken sides in the naming rights battle for biosimilars.  In a recent letter to the FDA, a group of physicians has taken the stance that biologic and biosimilar drugs should in fact have unique names.  This letter comes weeks after another piece of mail showed up at the FDA headquarters requesting that the agency not require distinct names for the two types of drugs.  The lobbying is part of a struggle between biologics manufacturers who want to protect their brand equity by requiring separate names and potential biosimilar manufacturers wanting to piggy back off that equity by using the original drug names for their products.

The letter, signed by 23 different physicians, claims that no matter how similar drugs might be, they can cause different reactions among patients with similar diagnosis’ and physical traits.  Distinguishing between the drugs is key and the group feels similar names could get in the way of that.   

“A biosimilar will only be similar, but not identical to the reference product for the foreseeable future. Distinct nonproprietary names will help to alert physicians that each product, while safe and effective, may differ slightly,” the group writes to the FDA.  “Rather than deter physicians from prescribing these products, we believe that allowing physicians to know the exact product that they are prescribing will increase confidence, thus encouraging more robust utilization of biosimilars than may develop without this transparency.”

A recent survey found that in the Europe (where a robust biosimialr market already exists), 61% of physicians prescribing biologics or biosimilars were of the understanding that if two products shared an international non-proprietary name, they were approved for all of the same indications. 

Other lobbying efforts on this policy include a number of petitions submitted to the FDA over the last few weeks.  While the organization has been mum on a possible decision, the market may push their hand sooner rather than later.  Two drug makers are already seeking regulatory permission to sell certain medications meaning that at least one biosimilar could become available next year. 

Until then, the letters and petitions will likely continue to fill the mailboxes at the FDA’s headquarters.

Want more on the latest in the biosimilars industry? Join us for the 15th Annual Business of Biosimilars meeting, October 20-22 in Boston, MA.  Download the agenda to see what else is on tap.

SAVE $100. Register here and use code XP1986BLOG.

Follow us on Twitter: @FutureOfBiopharma & @Biosimilars
Join us on LinkedIn

Share this article with your social network, just click below to share now!

Share |

FDA Tentatively Approves Lilly's New Diabetes Medication

The FDA has granted Eli Lilly “tentative” approval for a diabetes medication akin to Sanofi’s Lantus.  The drug, to be marketed as Basaglar, is a long-lasting insulin injection that helps to control blood-sugar levels and is essentially a knockoff of the Sanofi version.

The new medication, however, won’t reach shelves for at least 30 months as Sanofi has filed a suit claiming patent infringement.  The drug could hit the market earlier if the court rules in favor of Eli Lilly but is in a holding pattern until then.  Lantus is scheduled to come off of patent February of next year.  This news comes months after Merck divulged plans to develop its own knockoff of the diabetes medication. 

Basaglar has the same amino acid sequence as Sanofi’s drug but for technical reasons is not considered a biosimilar—although for all intents and purposes, it is one.  By European standards, the drug does actually fall under the biosimilar classification and goes by the name Abasria.    

Said Christophe Arbet-Engels, Vice President, Metabolic-clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc., "Because of the combined diabetes, development and commercialization experience of Lilly and Boehringer Ingelheim, we are confident that Basaglar, upon final approval, will become a valuable treatment choice for people who need a basal insulin to manage their type 1 or type 2 diabetes."

The biosimilars news is going to keep coming. We’ll have the breakdown of the latest industry updates and trends at the Business of Biosimilars conference. Join us October 20-22 in Boston, MA. Download the agenda here to see what’s on tap.

SAVE $100. Register here and use code XP1986BLOG.

Follow us on Twitter: @FutureOfBiopharma & @Biosimilars
Join us on LinkedIn

Share this article with your social network, just click below to share now!

Share |

1st Annual Women Leaders in Pharma and Biotech Dinner Series

IIR is committed to the support and growth of women in the life sciences industry and after much success with the annual Women's Clinical Leadership Forum at the Partnerships in Clinical Trials conference, we're thrilled to introduce the Inaugural Women Leaders in Pharma & Biotech Dinner Series:

October 20, 2014 | 6:00 – 8:30PM

Omni Parker House | Boston, MA

View the full agenda and speaker lineup.

Reserve your seat today.

We invite established leaders and up-and-comers in the pharmaceutical industry — both women and men of all levels — to attend.

Take part in lively and open conversation amongst leaders in the biomedical, bio-technology, diagnostic, health informatics, healthcare, medical device, and pharmaceutical sectors as they discuss strategies to help women work their way up the life sciences ladder.

Don’t forget to check out IIR’s other events in Boston this October 20-22:

• ·   15^th Annual Immunogenicity and for Biotherapeutics
• ·   10^th Annual Bioassays & Bioanalytical Method Development
• ·   15^th Annual Business of Biosimilars

Questions? Contact Marina Adamsky. 

Share this article with your social network, just click below to share now!

Share |

Biosimilars Can Save Money and Lives. Why the Delay?

Biologic drugs are used to treat a number of serious, life threatening diseases and save countless lives.  They are, however, exceedingly expensive.  The average daily cost of a biological in the U.S. ($45) dwarfs that of chemical drugs ($2).  Annually, some of these drugs can cost patients as much as $400,000.  The question becomes “how do we make these treatments more sustainable?”  The short answer to that question centers around biosimilars as one study estimates they have the potential to save north of $250 billion from 2014 to 2024. 

 

The long answer to that question, however, is not as straight forward.  Manufacturers of biological drugs can continue to charge monopoly prices as long as those drugs remain under patent protection.  Even as these medications begin to come off patent, many over the next few years, the road for biosimilars to enter the market is not exactly paved.  While many other countries (Australia, Canada, and the EU specifically) have had a market for biosimilars since 2006, the US policy for entry of these drugs remains ambiguous. 

A big part of this delay can be attributed to the FDA’s lack of progress in establishing guidelines for the approval of biosimilars.  Although they did accept their first biosimilar application last week, there still lacks a definitive set of regulations.  Tentative guidelines had been provided both in 2012 and 2014 but a final set is still in progress. 

This uncertainty in the regulatory process has caused apprehension among many drug companies and left fewer players vying for a place in the market.  Said one pharmaceutical executive, “I would like absolute clarity before we make a large investment. The quality of the decision is worth more than speed.”

While the FDA wavers in putting a process in place, biologics manufacturers have engaged in stall tactics.  The longer biosimilar drugs stay off the market, the longer these companies can continue to enjoy massive profits—reportedly as much as $100 million a month for some drugs.  The latest strategy employed involves disputing the naming system to be put into place for these drugs.  Biologics manufacturers have lobbied to maintain separate names, and the equity that goes with those names, from competing biosimilars.

While this dispute carries on, patients are missing out on billions of dollars in savings.  Many have called for the FDA to re-calibrate their priorities and fast track a set of guidelines that would allow biosimilars to hit the market sooner.  Other countries have had regulations in place for almost eight years while we wait for officials to perfect ours.  Until then, drug companies will continue to pad their pockets with massive profits from these drugs.   

Biosimilars is projected to be a lucrative industry. Can you afford to miss out? We’ll have the latest industry news and trends at the Business of Biosimilars conference. Join us October 20-22 in Boston, MA. Download the agenda here to see what’s on tap.

SAVE $100. Register here and use code XP1986BLOG.

Follow us on Twitter: @FutureOfBiopharma & @Biosimilars
Join us on LinkedIn

Share this article with your social network, just click below to share now!

Share |

Biosimilars: The (Brand) Name Game

What’s in a name?  A lot if you’re talking about biosimilars.  The FDA recently received a letter from a 32 member coalition consisting of major pharmacies, health insurers and unions asking that they not require biosimilars to be given different names than biologics.  The group claimed that with distinct names for biologics and biosimilars, there’s an increased risk for medication errors as well the potential to slow the adoption of cost-saving drugs. 

The letter states, “Requiring different INNs (International Nonproprietary Names) for biologics and biosimilars could lead to patient and prescriber confusion, increasing the possibility of medication errors, and would also effectively separate the biosimilar from existing safety information about the underlying molecule.”

This request comes less than a year after the US Senate made a similar request to the FDA.  The letter from the senate states that “There is already a precedent for shared names (e.g., erythropoietins, somatropin, interferon), which has not resulted in any known issues.”  The more recent letter reiterated that argument and while also pointing to the fact that shared INNs have been successfully applied in the EU, Canada, Australia and Japan. 

There is also a concern that unique names could confuse both patients and prescribers and potentially hinder the adoption of these biosimilars and the cost savings associated with them.  The letter states there is anywhere between $42 billion and $108 billion in savings at stake over the first ten years of the biosimilar market. 

One group not on board with utilizing the same INNs?  Brand name drug manufacturers.  A distinct marketing advantage lies within these names and drug manufacturers are not willing to share them.  They claim that having unique names would make it easier to track adverse events in patient records—A claim refuted by generic drug makers who say these events can be identified through national drug codes.

While they’ve yet to institute a naming policy, indications are they may be waiting for a cue from the World Health Organization.  The INN System is overseen by the WHO, however its recommendations are not mandatory.

We’ll have more on latest in the biosimilars industry at the Business of Biosimilars  conference. Join us October 20-22 in Boston, MA. Download the agenda here to see what’s on tap.

SAVE $100. Register here and use code XP1986BLOG.

Follow us on Twitter: @FutureOfBiopharma & @Biosimilars

Join us on LinkedIn

Share this article with your social network, just click below to share now!

Share |

Biosimilars Challenges Facing US Companies

Estimates for biosimilar approval in the United States range anywhere from two to five years, but that may only be the start of some considerable challenges for US drug makers. 

The global market for oncology biosimilars is expected to boom over the next few years and predictions have that market alone generating between $6 and $12 billion by 2020.  A recent IMS report predicts the US will have a direct impact on the global reach of these products and this potentially lucrative business.  Explains the author of the report, “The US is the largest biologic market by size, and is pivotal to the success of the overall biosimilar market.”

But if the U.S. is to become the factor everyone expects, it will not be without overcoming their share of obstacles.  The report found the US to be trailing the rest of the world in biosimilar development primarily due to a complex regulatory process.

Said Javier Coindreau, MD, vice president of global medical affairs for Pfizer Biosimilars Business Unit, in a recent interview with Specialty Pharma Times:

“One of the most important roadblocks is clarity in the regulatory pathways. The pathways are evolving all the time, and this is especially true in the biosimilar world. The current regulation doesn’t provide the needed clarity for specific molecules. One of the most challenging parts is when we submit drug submission packages with the best analysis finding the best chance for being approved, sometimes we struggle in identifying what exactly are going to be the demands of the regulatory agencies because the current regulations have many grey areas that need to be clarified case by case.”

Among other obstacles are the struggle in proving a biosimilar is the same product as the name brand.  Not only is it difficult to prove that a biosimilar is the same product as a name brand, but the process of proving that similarity is not well defined. 

Coindreau cited another reason that’s overlooked by many.  Difficulty in recruiting patients for clinical trials is an obstacle not just for US drug makers, but for global companies as well.  He discussed the idea that patients would be more apt to enter a trial for a new treatment as opposed to one that is supposedly the same.  “They think if I’m going to enter a trial, I’m going to do it for a new molecule not something that’s the same as the previous one,” he said. 

Whether the approval for biosimilars in the US is two years from now or five years, there’ll be a host of challenges for drug companies.  We’ll have more on those challenges at the Business of Biosimilars conference.  Join us October 20-22 in Boston, MA.  Download the agenda here to see what’s on tap.

SAVE $100. Register here and use code XP1986BLOG.

Follow us on Twitter: @FutureOfBiopharma & @Biosimilars

Join us on LinkedIn

Share this article with your social network, just click below to share now!

Share |

IIR's 15th Annual Business of Biosimilars Brochure is Ready for Download!

The biosimilars industry is projected to grow $200 billion by 2015.  Are you ready to capitalize on it?  IIR’s industry-leading 15th Annual Business of Biosimilars is back this October 20-22, 2014 in Boston and we’ll show you how to capture that growth through:

• •  Identifying business opportunities by analyzing the commercial realities of the market
• •  Increasing market access by expanding your global footprint in the US, EU and emerging markets
• •  Gaining clarity by understanding regulatory & legal considerations
• •  Driving commercial success through proactive clinical development

Download the brochure for full details.

You can personalize your agenda here.

Save $400 when you register by July 25^th.  Plus, you can save an extra $100 as a reader of this blog.  Register here and use code XP1986BLOG.

Questions? Reach out to me at MMadarasz@iirusa.com.

See you in October,

Mike Madarasz

Follow us on Twitter

Join us on LinkedIn

Share this article with your social network, just click below to share now!

Share |

The 14th Annual Business of Biosimilars Agenda Is Now Available!

With Biosimilar development interest growing and the first approved monocolonal antibody in Europe this past July it will only be a matter of time before the first Biosimilar application is submitted in the US. Biosimilar market penetration is expected to grow exponentially. Are you prepared to develop a biosimilar strategy that avoids wasting time and money to be the first to market?

The 14th Annual Business of Biosimilars provides insights from market leaders including Teva, Mylan, Hospira, Sandoz, Momenta, and Boehringer Ingelheim on choosing the best pathway for the development, approval and market access of a biosimilar product. The is the only event out there that provides a unique multidisciplinary approach with a one-stop shop for all relevant topics related to Biosimilar development and market access.

Highlights include:

• THE US BIOSIMILAR LANDSCAPE
• THE GROWING GLOBAL BIOSIMILAR MARKET
• ANALYTICAL CHARACTERIZATION
• BIOSIMILAR POLICY MAKING
• MATCHING A REFERENCE PRODUCT
• CLINICAL DEVELOPMENT
• PARTNERSHIPS

To learn more, download our full agenda.

The 14th Annual Business of Biosimilars will take place October 15-17, 2012 in Boston, MA. As a reader of the Business of Biosimilars blog, you’ll receive 15% off when you use code XP1886BLOG to register. Have any questions about the event? Feel free to contact Kate Devery at kdevery@iirusa.com or visit the webpage.

Cheers,
The Business of Biosimilars Team

Business of Biosimilars Webpage
Join our Linkedin Group
Follow Us On Twitter

Share this article with your social network, just click below to share now!

Share |

Business of Biosimilars Day 1: Biosimilar R&D Planning and Protecting IP

Today's guest post features highlights from the first day of the Business of Biosimilars and Generic Drugs Summit and is authored by Amy M. Belton, PhD, Research Associate, Johns Hopkins University School of Medicine.

The presenters for the Summit portion of the 13th Annual Business of Biosimilars and Generic Drugs meeting discussed the biotherapeutic research and development, and legal criteria surrounding biosimilar development. The day began with a presentation from Michael Malecki, Senior Manager, Biosimilars, Amgen who discussed the importance of long term follow up of biosimilar therapies. He stressed the importance of placing value in due diligence and putting patient safety above all. This was further highlighted by the World Health Organizations Global Harmonization Guidelines, which stated that biosimilar manufacturers should look for differences that could ultimately be clinically meaningful.

The presentation by Magdalena Leszczyniecka, CEO, STC Biologics focused on potential variability during biosimilar development and the importance of robust analytics in mitigating potentially harmful effects to patients. She also stressed that during biosimilar development manufacturers must focus more on quality than high titers. Also, modifications to the biosimilar can occur during cell culture and/or purification suggesting that both upstream and downstream processes impact overall safety and efficacy.

The presentation by Michael Bauer, IP Counsel, Hospira stressed that the size and complexity of biosimilars offers increased patentability for parties developing biotherapeutics. He also stressed that biosimilar manufacturers must be aware of entire the process of biosimilar litigation and begin long before filing to assemble a legal team, to include additional backup counsel, to properly defend its biosimilar interests. In addition, Mark Hyman, IP Counsel, Human Genome Sciences gave a detailed description of the legal aspects of IP litigation with respect to biosimilar manufacturers in litigation with innovator companies. The final presenter was Michael Castagna, Executive Director of Immunoscience, Bristol Myers Squibb who stressed gave an assessment of the key areas that biosimilar manufacturers need to be aware of when deciding to develop biosimilars.

Share this article with your social network, just click below to share now!

Share |

See who’s attending the Business of Biosimilars and Generic Drugs event

The 13th Annual Business of Biosimilars & Generic Drugs event is taking place in 2 weeks! The following companies from over 10 countries around the world will be in attendance:

* Abbott Laboratories * Amgen Inc * Amneal Pharmaceuticals * AriVan Research LLC * Baxter Healthcare Corp * Biogen Idec * BioProcess International * Biotechnology Industry Organization * Boston Oncology * Bristol-Myers Squibb * Burrill & Co * Celltrion * Covance Laboratories Inc * Endo Pharmaceuticals Inc * Express Scripts * Federal Trade Commission * Gedeon Richter USA Inc * Greenblum & Bernstein PLC * HartmannWillner LLC * Harvest Moon Pharmaceuticals * Hoffmann-La Roche * Hospira, Inc. * Human Genome Sciences Inc * Janssen-Ortho Inc * Johnson & Johnson * Lathrop & Gage * Legasis Services * McAndrews Held & Malloy Ltd * Medac GmbH * Meiji Seika Pharma Co Ltd * Merck Serono SA * Momenta Pharmaceuticals Inc * Mylan Pharmaceuticals Inc * Nova Venture Fund Ltd * Novation, LLC * Par Pharmaceutical * Pharmac * Roxane Laboratories Inc * Sandoz Inc * Sawai Pharmaceutical * Shire * Sigmapharm Laboratories, LLC * STADA PharmDevelopment * STC Biologics Inc * Sutherland Asbill & Brennan * Teva Pharmaceuticals * Thomson Reuters * Valin Technologies * Wockhardt USA * Xencor Inc *

For more information on the event, visit the webpage.

The 13th Annual Business of Biosimilars and Generic Drugs Event will take place September 10-12, 2012 in Boston, MA. As a reader of this blog, you receive an exclusive discount of 25% off of the standard rate when you register to join us. Simply use priority code XP1786BLOG. Have any questions about the event? Feel free to contact email jpereira@iirusa.com.

Share this article with your social network, just click below to share now!

Share |

Celltrion Gains Approval for Remicade Biosimilar

Today's guest post is authored by Amy M. Belton, PhD, Research Associate, Johns Hopkins University School of Medicine.

A leading Korean biopharmaceutical company, Celltrion, recently announced their successful approval by the Korean Food and Drug Administration (KFDA) to develop the biosimilar monoclonal antibody Remsima.  The biosimilar “Remsima” is a version of the blockbuster drug Remicade (inflixamab) by Johnson and Johnson.  Remsima was approved under the global biosimilars guidelines making it the world first true biosimilar antibody.  Remsima has been approved by the KFDA for the treatment of rheumatoid arthritis, ulcerative colitis (UC), Crohn’s disease, ankylosing spondylitis and psoriasis.

The cost of treatment with Remicade can range from $19000-$22000 a year per patient. These costs are usually covered by major medical insurance. The biosimilar Remsima could offer a 20-40% decrease in cost for the payor and patient. This offers significant decreases in the costs associated with treatment. Celltrion started as a contract manufacturing organization and is now entering into agreements with companies such as Hospira to develop biosimilars for other blockbuster drugs.

At next month's 13^th Annual Biosimilars and Generic Drugs meeting in Boston, MA participants will be able to get insight from ShinJae Chang, VP, R&D Celltrion into the strategies used to develop and market biosimilars globally.  For more on this session, download the agenda.  If you'd like to join me in Boston, register today and mention code XP1786BLOG to save 15% off the standard rate!

Do you think Celltrion will be able to successfully market Remsima globally (US, EU markets)? If not, what do you think will be some of their roadblocks? Do you think they are now the global leader in biosimilar development?

Share this article with your social network, just click below to share now!

Share |

Biosimilars Spotlight: Important take away points in the current FDA draft guidelines

Recently the Business of Biosimilars and Generic Drugs team sat down with Mark McCamish, the Global Head of Biopharmaceutical Development, Sandoz International, a Division of Novartis to discuss the current state of biosimilars and many of the regulations,or lack there of, facing the United States.

Today's Question: What do you consider to be the most important take away points in the current FDA draft guidelines? What developments are you most hoping to see in the next iteration?

Mark's Answer:

I think the key take away points from the current FDA draft guidelines are that they show flexibility, they have a step-by-step approach, and they have a science-based understanding. With that flexibility a sponsor such as Sandoz can come in and discuss their analytical characterization and their biologic characterization of their molecules, which is a foundation for appropriate reduction of clinical trials and pre-clinical trials. The draft guidances did show flexibility and if that flexibility can be woven into the final draft/the final guidances, it will be a step for FDA in terms of helping us in the development and commercialization of biologics.

There are some challenges that still remain. Interchangeability wasn’t addressed and there were some challenges potentially in some of the clinical trial scenarios addressing immunogenicity. So, those have to be further refined. But, we appreciated the flexibility, the step-by-step approach and a reliance on the analytical characterization of the molecules themselves.

For access to the entire podcast and transcript, download it here.

The Business of Biosimilars and Generic Drugs Summit will take place September 10-12 in Boston, MA. For more information on the speakers and presentations for this year's event, download the brochure. if you'd like to join us, register today and mention code XP1786BLOG to save 25% off the standard rate!

Share this article with your social network, just click below to share now!

Share |

Business of Biosimilars & Generic Drugs Session Spotlight: When Being the Same is Good Enough: Building Public Confidence and Interest in Biosimilars

There’s an enormous amount of public confusion and misconceptions about the efficacy and safety of biosimilars, even in markets such as Europe where these products are already available. By anticipating and countering the public’s fears you can assure better product uptake.  Today we feature the session "When Being the Same is Good Enough: Building Public Confidence and Interest in Biosimilars," presented by Alex Bruni, VP for Commercial Operations, Merz Pharmaceuticals.

Alex Bruni

The Business of Biosimilars and Generic Drugs will take place September 10-12, 2012 in Boston, MA.  For more information on the rest of the program, download the agenda.  If you'd like to join us in Boston, register today and mention code XP1786BLOG to save 25% off the standard rate!

Featured Session: When Being the Same is Good Enough: Building Public Confidence and Interest in Biosimilars
Featured Speaker: Alex Bruni, VP for Commercial Operations, Merz Pharmaceuticals
About the Session: Even as small-molecule generics have grown to take the majority of the prescription market, there are still widespread misconceptions and apprehensions about their quality and effectiveness. Biosimilars have yet to prove themselves in the U.S. market, but they will surely face the same public scrutiny and “urban legends.” How can you best confront counter-messaging and position your product as the best in its class?

Share this article with your social network, just click below to share now!

Share |

Exclusive Interview - Dr. Mark McCamish, Global Head of Biopharmaceutical Development, Sandoz

Image Source

The 13th Annual Business of Biosimilars & Generic Drugs offers you access to an exclusive interview with Dr. Mark McCamish, Global Head of Biopharmaceutical Development at Sandoz.

Dr. McCamish’s remarks cover such key topics as:

• • The critical role biosimilars can play in increasing access and lowering healthcare costs
• • Key takeaway points in the current FDA Draft Guidelines on biosimilar development.
• • Implications of using unique names to identify biosimilars
• • Importance of communication in building acceptance and understanding of biosimilars

Download download the interview.

The 13th Annual Business of Biosimilars and Generic Drugs Event will take place September 10-12, 2012 in Boston, MA. As a reader of the Future of Biopharma blog, you receive an exclusive discount of 25% off of the standard price when you register to join us and use priority code XP1786BLOG.  For more information on this year's program, download the brochure here.  Have any questions about the event? Feel free to contact Jennifer Pereira.

Share this article with your social network, just click below to share now!

Share |

Business of Biosimilars & Generic Drugs Session Spotlight: Analyze the Regulatory Criteria that your Generic Drug Candidate Must Meet

Amidst all the focus on the Affordable Care Act, it is important to remember that there were other important new codes taking effect this year regarding the reimbursement and user fees for generic drugs. Candis Edwards, Senior Director for Regulatory Affairs and Compliance at Amneal Pharmaceuticals, will detail the best ways to account for new generic drug user fees in your business plan, as well as providing a timely update on factors that had changed concerning REMS agreements between branded and generic pharma companies.

Today, we highlight the session Analyze the Regulatory Criteria that your Generic Drug Candidate Must Meet presented by Candis Edwards, Senior Director, Regulatory Affairs & Compliance, Amneal Pharmaceuticals.  Business of Biosimilars and Generic Drugs will take place September 10-12, 2012, in Boston, MA.   For more information on the rest of the program, download the agenda.  If you'd like to join us in Boston, as a reader of this blog, register to join us and mention code XP1786BLOG and save 25% off the standard rate!

Featured Session: Analyze the Regulatory Criteria that your Generic Drug Candidate Must Meet
Featured Speaker: Candis Edwards, Senior Director, Regulatory Affairs & Compliance, Amneal Pharmaceuticals
About the Session: 2012 saw the installation of a new regime of user fees for sponsors of generic drug candidates. This timely session will analyze the impact that these changes will have on your business model and appropriate methods for making the best use of your regulatory interactions.

• • Anticipate and account for new user fees in your business plan
• • Itemize the differences between new user fee structure and earlier payment systems
• • Update on important factors concerning REMS agreements between generic and brand companies

Share this article with your social network, just click below to share now!

Share |