New Report: Convergence in Boston: How multidisciplinary R&D is driving bench-to-bedside breakthroughs

The area in and around Boston, Massachusetts is as dense with world-renowned scientific experts as anywhere on earth. Here, in an area a little larger than one square mile, researchers from Harvard University, Massachusetts Institute of Technology (MIT), and a multitude of biotechs and Big Pharmas are driving the evolution of the technology and business of science. In doing so, research teams are increasingly looking to share data, research, and ideas.

Collaboration has always been key to science, but, as researchers have taken on ever-more complex projects, the need to work with people from different disciplines, backgrounds, and organizations has increased. Such collaborations run counter to the secretive, ego-driven, or financially-motivated sides of science, but have nonetheless taken root, even in for-profit fields, as organizations have realized the value of expanding the breadth of their internal expertise while looking outside of their walls for collaborators. We at Biotech Week Boston are excited by the possibilities that this new era of collaboration can bring to biotech. We’ve asked writer Nick Paul Taylor (Nature, Fierce Biotech, Regulatory Focus) to report on several innovators who are contributing to this convergence of disciplines and ideas here in Boston.

In this report, Nick looks at three people: "who have embraced the collaborative, multidisciplinary ethos and, in doing so, have influenced science, business, and the lives of patients to a far-greater degree than would have been possible through an isolationist approach. Their goals are diverse. One is working to improve drug availability in low and middle-income countries through the advance of biomanufacturing. Another is looking to nature for answers to biomedical problems that blight the lives of patients. Our third is coordinating a global campaign to unlock the secrets of the genome."

Nick continues: "What links the three researchers is not the type of science they do, but the way they do it. Each is an example of what scientists, particularly in hotspots such as Boston, can achieve when they are open to the sharing of data, research, and ideas."

We hope you enjoy Nick’s in-depth report. We are proud to say that all three innovators featured in this report will be speaking at Biotech Week Boston this October 2016. You can catch up with Jeffrey Karp’s newest discoveries and research at Biotech Week Boston's Cell and Gene Therapy Bioprocessing and Commercialization event. Jeffrey's talk is entitled "MSCs on steroids". Stacy Springs will be on a panel entitled "Industry-Academia Collaboration in Translational Research and Biomanufacturing of Next Generation Biologics at the Bioprocess International Conference and Exhibition. And Kristin Ardlie will discuss discuss GTEx Data and Analysis at Biorepositories and Sample Management.

We invite you to download “Convergence in Boston: How multidisciplinary R&D is driving bench-to-bedside breakthroughs.” The report is free and no email address or registration is required - so go ahead and share the link!

What exactly is #BiotechWeekBoston?

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

Share |

From bench to bedside: Stacy Springs and the BioMAN program connect theoretical concepts to real world application

In 1978, there were just 30 patents granted for biopharmaceuticals. Now biologic drugs make up more than 28% of all pharmaceutical sales - $41.7 billion in 2013. MIT CBI’s BioMAN program is focused on translating all of the research into successful manufacturing, so theoretical concepts can be turned into real world applications. They do this by bringing together thought leaders from across the biopharmaceutical industry including manufacturers, vendors, the FDA and academia. They also leverage the MIT research they have access to in order to advance new technologies as well as assess the global landscape.

This year MIT put out a report called “Convergence: The Future of Health” which states: “Convergence comes as a result of the sharing of methods and ideas by chemists, physicists, computer scientists, engineers, mathematicians, and life scientists across multiple fields and industries…it needs to be applied to help solve many of the world’s grand challenges.” To that we can add - as scientific discoveries progress collaboration between the academic world, the government and manufacturers is key to solving these challenges. That is what BioMAN was set up to do.

We at Biotech Week Boston have asked writer Nick Paul Taylor (Nature, Fierce Biotech, Regulatory Focus) to report on several innovators who are contributing to this convergence of disciplines and institutional boundaries here in Boston, and Nick reports on the work Stacy Springs  is doing at BioMAN Institute. At BioMAN Stacy is the Director of the Biomanufacturing Program and Executive Director of the Consortium on Adventitious Agent Contamination in Biomanufacturing. We’re proud to feature her in our report “Convergence in Boston: How multidisciplinary R&D is driving bench-to-bedside breakthroughs”. BioMAN “fosters a collaborative research environment that brings together thought leaders from industry, the government/FDA and academia.” Click to download and read about Stacy Springs and MIT’s CBI BioMAN program (no email address or registration is required).

We hope you enjoy Nick’s in-depth report. You can catch up with Stacy Spring’s newest research at Biotech Week Boston's Bioprocess International Conference and Exhibition event this October. Stacy will be on a panel entitled "Industry-Academia Collaboration in Translational Research and Biomanufacturing of Next Generation Biologics".

What exactly is #BiotechWeekBoston?

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

Share |

8 Reasons Why You Can't Miss BPI West | Plus! Register by Friday, 1/22 and Save $400

8 Reasons Why You Can't Afford to Miss BPI West:

1. First and only phase-based format event that fosters the collective sharing ideas, strategies and solutions across departments to improve speed, cost and quality at every stage of development
2. Breakdown the barriers and collaborate across stages of development to achieve end-to-end integration
3. Discover the latest breakthroughs on successfully implementing continuous processes and linking them together to achieve fully continuous processing from cell culture through to drug substance
4. Accelerate the design and development of novel drug substances for next generation therapeutics by integrating candidate selection and early development
5. Develop strategies for fast tracking early stage biologics and managing the life cycle of a break through therapy designated product
6. Speed up and streamline the transition into development by utilizing manufacturability assessments, automation, and QbD in late stage discovery and R&D
7. Implement disruptive technologies and achieve operational excellence to drive manufacturing efficiencies and minimize costs
8. Uncover the future of single-use systems and next generation facility design, modelling and management in current and emerging markets

Want to learn more about the event? Download the brochure.

Register by this Friday, January 22nd and receive up to $400 in savings - Use the code BPIWEST16BL to save.

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 |

Higher-Order Structure Comparability: Case Studies of Biosimilar Monoclonal Antibodies

Today, we feature an article from our partners at BioProcess International Magazine. This is an excerpt from the article Higher-Order Structure Comparability: Case Studies of Biosimilar Monoclonal Antibodies.

Higher-Order Structure Comparability: Case Studies of Biosimilar Monoclonal Antibodies

For successful development and marketing of biosimilars with desired efficacy and safety, this industry recognizes the central importance of extensive analysis comparing innovator and biosimilar molecules. It is also recognized in the biotechnology arena that our understanding of complex biologics remains limited even though we have many analytical technologies available to us. A recent FDA guideline for biosimilar development states the following:

The three-dimensional conformation of a protein is an important factor in its biological function. Proteins generally exhibit complex three-dimensional conformations (tertiary structure and, in some cases, quaternary structure) due to their large size and the rotational characteristics of protein alpha carbons. The resulting flexibility enables dynamic, but subtle, changes in protein conformation over time, some of which may be absolutely required for functional activity. . . At the same time, a protein's three-dimensional conformation can often be difficult to define precisely using current physiochemical analytical technology. (2)

With an understanding of our current capabilities in biologics higher-order structure (HOS) characterization, we developed an antibody array enzyme-linked immunosorbent assay (ELISA) to provide a new approach for evaluation of MAb HOS.

In a previous report, we showed that antibody arrays developed specifically toward marketed MAbs could detect structural differences that correlated well with other analytical readouts, including bioassays and glycosylation analysis (8). Experiments have shown that antibody arrays can detect subtle changes that sometimes were not detected by bioassays or any other analytical technologies currently available.

The arrays use more than 30 polyclonal antibodies to cover an entire MAb molecule, thereby measuring its surface-epitope distribution systematically and sensitively, whereas other assays measure only part of the molecule or give an average status of a biologic's population. So antibody array technology should be able to provide a unique measurement of biosimilar MAb HOS comparability. We suggest that additional surface exposure from a baseline readout be termed conformational impurity(8).

Another advantage for antibody array technology is its ability to quantify small amounts of conformational impurity using an easy-to-operate ELISA format. As little as 0.1% conformational differences could be detected from all areas covered by the polyclonal antibodies, thus providing for accurate and sensitive measurement of the status of a MAb's conformation. No data yet correlate the impact of conformational impurity with efficacy and safety of a biosimilar MAb. But it is reasonable to postulate that more conformational impurities (epitope exposures) would increase the risk for potential immunogenicity if those additional epitopes were originally inside the innovator MAb molecule, which has been proven to be tolerated by patients’ immune surveillance systems. A significantly different new epitope exposure could break self-tolerance to a MAb and induce immunogenicity. Furthermore, increased exposure of new epitopes raises the possibility of a biosimilar MAb interacting with other regulatory proteins in a patient's body, causing off-target effects.

Read the full article and see detailed illustrations here.



You can find out more about manufacturing process and meet and network with other professionals in the bioprocessing field at this year's BioProcess International Conference and Exhibition.  As a reader of this blog, when you register to join us October 20-23 in Boston, you are eligible to receive 20% off the standard rate when you mention code BPI14BLOG.

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

Share |

Opportunities in biopharmaceutical production: Biologics and new technologies

Last year at the BioProcess International Event, we had the opportunity to sit down with a few of the speakers and discuss what they see is impacting their jobs, some of the opportunities in the industry and emerging markets he works in.

In this video,  Günter Jagschies, Ph.D., GE Healthcare addresses:

• -Where he sees the industry headed in the slow moving, regulated biopharmaceutical industry
• -How biosimilars will change the field over the next few years
• -How the cost of drug development needs to change
• -Emerging technologies

Watch the full video here:


GE Healthcare will return to BioProcess International this year as a Gold Sponsor and will be presenting the technology workshop Guidelines for the Selection of Chromatography Media (Resins) and Steps to Meet Specific Purification Challenges.  To find out more about this workshop and the rest of the program, download the agenda.  If you'd like to join us October 20-23, 2014 in Boston, MA for the BioProcess International Conference and Exhibition, as a reader of this blog, when you register to join us and mention code BPI14BLOG, you can save 20% off the standard rate!  Would you like to get invovled in the event?  Feel free to reach out to Jennifer Pereira.

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

Share |

2013 BPI Conference Pre-Event Podcast Series: Upstream Processing

We’d like to share with you 2013 BPI Conference Pre-Event Podcast Series! This edition is Upstream Processing and previews what you will experience while attending the 2013 BioProcess International Conference & Exhibition this coming September.

Each of these podcast speakers will be joining us this September 16-19, 2013 in Boston for the BioProcess International Event. Featured Podcasts in this month’s upstream series are:

• The BioProcess International Conference & Exhibition: 10 Years of Industry Excellence
• By Barry Walsh and Michael Keenan, Conference Directors, IBC Life Sciences
• Apoptosis of CHO Cells Monitored by a Novel Dielectrophoretic (DEP) Cytometer
• By Michael Butler, PhD, Professor of Microbiology, University of Manitoba
• Challenges to the Entry of New Biologics into the Market
• By Joanne T. Beck, Ph.D., Vice President, Process Development, Shire Human Genetic Therapies
• Investigation and Reduction of Performance Variability in Single-Use Cell Culture Bioreactors
• By Rajesh Krishnan, PhD, Associate Director, Cell Line & Upstream Process Development, Gilead Sciences
• Fast Identification of Reliable Hosts for Targeted Cell Line Development
• By Yongping Crawford, PhD, Scientist, Early Stage Cell Culture, Genentech

To listen to each of these podcasts, visit the official webpage of the podcast series. 

Want to join these speakers and more at BioProcess International?  As a reader of this blog, we’re offering you a save 20% savings off the standard conference rates when you register to join us and mention priority code BLOG13JP when you register!*

Have any questions about the event or the program or want to get involved? Contact me jpereira@iirusa.com.

*This discount only applies to new registrations.

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

Share |

Indian Supreme Court: Glivec® Patent Case

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

A landmark case will soon be decided in the Indian Supreme Court between the Swiss drugmaker Novartis and the Indian patent office. The case is set to begin on September 11, 2012 regarding whether Novartis should be awarded a patent for the cancer drug Glivec®. Glivec® is prescribed to treat chronic myeloid leukemia and many gastrointestinal cancers. The case rests on whether or not Glivec® should be considered an innovative therapy worthy of patent protection.

The case spans from 2006 when Novartis attempted to gain patent protection for Glivec® but was denied by the Indian courts due to Novartis’ receipt of a patent in 1993, for an earlier Glivec® formulation, that has since expired. Novartis claims that the new Glivec® is innovative and deserves patent protection for that reason. However, section 3(d) of the Indian Patent law has restrictions on approving multiple patents for a single drug. The Indian government does not consider the new formulation of Glivec® to be innovative. The Indian government includes this clause in the patent law to prevent companies from “evergreening” a therapy. This would allow companies to continuously patent formulations, claiming innovative modifications, essentially preserving patent protection.

The outcomes of this case will determine whether the Indian government puts patient health before profits. With the increase in healthcare costs rising globally, the need for more affordable therapies is an issue for governments around the world. This is especially true in emerging markets such as India and China where much is being done to increase the overall health and wellbeing of the general population. The outcome of this case will influence the level at which the Indian government can and will provide healthcare for its citizens.

How do you think the Indian Supreme Court should rule on this issue? Do you think Novartis should gain FDA approval for Glivec® based on its innovative new formulation for Glivec®?

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

Share |

Woodcock reports release of biosimilars is imminent

While the release of guidance for biosimilars have been long awaited by the Pharmaceutical industry, Janet Woodcock has stated it could come as early as next week, but definitely before the end of the year.  Reuters reports that Pharma representatives and the FDA have come to an agreement on how fees would be collected to support the biosimilars process and a pathway.  While biosimilars are a generic version of biologics, which are used to treat such diseases as diabetes and multiple sclerosis.

What do you anticipate to see from the long-awaited biosimilars draft guidance?

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

Share |

Approval for biologics will not come easy with healthcare reform

With the new healthcare reform, there is an option for biosimilars to be approved for US use. However, due to the complexities of making the similar drug, the FDA will be more rigorous with their approval process, assuring that the generics and original drugs genetic structures are the same. Read the full article at Fierce Pharma here.

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

Share |

European healthcare cuts benefit biologic makers

According to a recent article at Reuters, the European Pharma industry is looking to its generic segments to profit. Sanofi aventis, Merck, Teva and Astra Zeneca have all indicated that they will look to strengthen their biologics divisions. Read the full article here.

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

Share |

2nd Annual Business of Biosimilars: New Dates & Venue Announced for 2010

September 20-22, 2010

Hyatt Regency Boston • Boston, MA

The biopharmaceutical market is at a crossroads. Some of the biggest-selling biologics are losing their patent protection, opening up a global market estimated at over $19 billion for biosimilars, otherwise known as “follow-on biologics” or “biogenerics”. Already we are seeing changing business models as a whole new set of global competitors emerges. As the industry moves forward, it asks itself:

*What will the new biosimilars market look like?
*How do you navigate regulatory challenges?
*Who can you partner with to leverage your company?
*What product launch and marketing strategies should you use?
*How do you ensure your economic success?

IIR’s 2nd Annual Business of Biosimilars conference delivers the tools you need to succeed in the biosimilar arena. Exchange ideas and best practices surrounding innovation, regulatory change, IP protection and patent litigation strategies, and commercial management.

Join leaders and industry experts to develop effective strategies to navigate scientific, regulatory, economic, and legal challenges to remain competitive in commercializing your biosimilar portfolio in the United States and abroad.

Do You Want Your Message To Reach Top Level Decision Makers?
To learn about how you can position your company as a leader and innovator through a custom sponsorship package, please contact Andrew Sinetar at 646.895.7472 or email asinetar@iirusa.com.

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

Share |

We invite you to join us tomorrow in Boston!

Coming up this week in Boston, September 23 - 25, we have three events that will bring professionals together to network, collaborate and learn about three of the most pressing topics in biopharma today: Vaccines, Biologics and Drug Delivery and Biosimilars.

We hope to see you there!

* * * *

The Vaccines Development Forum

The Vaccines Development Forum has added all new content to address rapid vaccine product in response to the world’s current pandemic. Explore the most mission critical updates and advances in the H1N1 flu vaccine rapid development with case studies and expertise from The National Institute of Health, GlaxoSmithKline, Vical, and CSL Limited.

Visit the Vaccines Development Forum Homepage


Visit the Vaccines Development Forum Agenda

* * * *

Biologics Drug Delivery & Beyond

Discover the latest scientific advances in biologics and RNA formulation and delivery at the Biologics Drug Delivery & Beyond event, coming up next month in Boston. Attending the event gives you exclusive access to experts from pharma, biotech, specialty pharma, and drug delivery companies and 15 + case studies for a clearer picture of where the opportunities and pain points lie, helping you to inject increased scientific strategies into your business decisions.

Visit the Biologics Drug Delivery & Beyond Homepage


Visit the Biologics Drug Delivery & Beyond Agenda

* * *

Business of Biosimilars

With US legislation for a biosimilars approval pathway making significant headway, many questions still remain for biotech, pharma and generic companies alike. Knowing this, The Business of Biosmilars Event is designed to address your key challenges and prepare you to compete in this dynamic new market.

Visit the Biosimilars webpage

Visit the Biosimilars Agenda

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

Share |

Are you getting ready for Biologics Drug Delivery & Beyond?

Biologics and RNA Drug Delivery is the groundbreaking conference showcasing cutting edge drug delivery technologies and advances in integrating them with biologic formulations to expand product pipelines.

We are pleased to bring this event to Boston, the hub of the east coast Biotech industry, making it easier and more affordable for you to attend than ever before. Attending the event requires no travel costs or investments.

• Gain competitive advantages by developing your biologic with needle-free delivery: discover the latest in needle-free delivery of biologics and learn how to reformulate your products for needle-free delivery
• Establish what technologies hold the most promise for advancing your biologics, RNAi, SiRNA, and DNAi pipelines to determine where investments should be made and resources should be allocated to
• Discover the latest scientific advances in biologics delivery and formulation for a clearer picture of where the opportunities and pain points lie, so you can inject a strategic POV into business decisions
• Address these development challenges and business opportunities with regards to how to overcome the challenges and formulate your drugs for different drug delivery methods

Visit our website for the comprehensive speaking faculty and complete agenda details.

So join us today and walk away with the technologies that will hold the most promise for needle-free delivery of biologics.

If you'd like to network with other professionals in the drug delivery field, join our LinkedIn group! Or follow us on Twitter at http://www.twitter.com/drugdeliveryiir!

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

Share |

Liquid protien could help in drug delivery

According to in-Pharma Technologies, a newly developed liquid protein, which would be the first in the world, and could help with the delivery of therapeutic proteins and high potency drugs.

Professor Stephen Mann who was incharge of the team that developed the protien stated “represents a possible way forward to a novel state of biomolecular matter, and could therefore have a number of important [biomedical] applications.”

Read the full article here.

If you'd like to network with other professionals in the drug delivery field, join our LinkedIn group! Or follow our Drug Delivery Twitter here.

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

Share |

Biotech Drugs: More or Less Exclusivity?

This article in telegram.com brings up the much talked about debate in biologics in exactly how many years should makers of drugs by exempt from generic competition. Many pills are hard to re-produce but there are many drugs that are made of simple chemicals and are easy to replicate. Congress is trying to approve legislation now that would allow the FDA to approve generic versions of biologic drugs, and this could save consumers a lot of money in the long-run.

The Health Committee has approved for 12 years of exclusivity for the biotechnology industry, but the Obama administration seems to think that 7 years is a fair compromise? Do you agree with the Obama administration?

If you're interested in networking with other professionals in the field of Biosimilars, join our LinkedIn Group here.

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

Share |

Exclusivity period for biologics

Obama believes that biologics should be able to face competition after seven years on the market instead of 12-14.

Nancy-Ann DeParle, director of the Office of Health Reform, and Peter Orszag, director of the Office of Management and Budget wrote a letter to Rep. Henry Waxman stating

"Lengthy periods of exclusivity will harm patients by diminishing innovation and unnecessarily delaying access to affordable drugs."

Read the full article here.

If you're interested in networking with other professionals in the field of Biosimilars, join our LinkedIn Group here.

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

Share |

Future Drug Sales Predictions Highlight Importance of Follow-on Biologics Legislation

According to Patent Docs, "six of the top ten selling drugs by 2014 will be biologics. Today, half of the top ten best-selling drugs are conventional small molecule drugs, as shown in the table below; in terms of sales, these drugs account for about 61% of the revenues garnered by the top ten best-selling drugs."

Check out the chart : Top 10 Drug Products by Sales in 2008

But by 2014, the number of drugs sold that are biologics "are predicted to account for a 75% of the revenues, an almost 2-fold increase in the relative contributions of biologic drugs to the sector."

Check out the chart: Top 10 Drug Products by Sales in 2014

According to the article, "some traditional Big Pharma companies stand to benefit from their association (partnering) or acquisition of biotechnology companies, with Roche being a clear example as purveyors of three of the top ten predicted best-selling drugs in 2014."

For more information, please click here.

Future Drug Sales Predictions Highlight Importance of Follow-on Biologics Legislation

Gather with other professionals to discuss the emerging trends in Pharma, including biopharma strategy, R&D, product marketing, clinical studies-- join Future of BioPharma, today!

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

Share |