The Latest Biosimilars Updates on Policy and Partnerships: See the new additions the Business of Biosimilars and Generic Drugs Agenda

The past 12 months have rocked the follow-on biopharmaceutical sector, with major new draft guidelines at last released by the FDA and the formation of a new wave of industry-leading strategic partnerships that will accelerate product development and commercialization.

Recognizing the unprecedented and time-sensitive importance of these developments, the 13th annual Business of Biosimilars & Generic Drugs conference is now announcing an updated conference program that adds even more depth to our coverage of these crucial topics!

We would like to share our revamped & rebalanced program brochure. We have made it easier to catch every discussion related to the new FDA draft guidelines, and we have given you more opportunities to share strategic lessons on market access that apply to both biosimilars and small-molecule generics.

Download the updated agenda.

Take special note of the following key topics:

Speaker
Richard Brudnick

• - KEYNOTE: Richard Brudnick, Vice President, Co-Head Business Development / M&A, BIOGEN IDEC presenting “The Art of the Biotech Deal – Biogen Idec, Samsung, and the Future of Follow-On Biologics”
• - KEYNOTE: Suzanne Munck, Chief Counsel for Intellectual Property, FTC presenting “Turn Antitrust Laws to Your Advantage in the Generic and Biosimilar Market”
• - Dominic Marasco, Executive Vice President, Business Development, INVENTIV HEALTH presenting “Building the Necessary Goodwill for Successful Biosimilar Rollout”

The 13th Annual Business of Biosimilars and Generic Drugs 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 XP1786LINK. Have any questions about the event? Feel free to email Jennifer Pereira.

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Best techniques and media for reassuring both patients and physicians about the quality of biosimilars

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 are the best techniques and media for reassuring both patients and physicians about the quality of biosimilars? Is there anything in particular from a purely messaging and outreach perspective that you believe the biosimilars community could learn from techniques previously established for small molecule generics?

Mark's Answer:

I think communication is really key. Martina Weise from the European Medicines Agency (she’s on the Biosimilars Working Party for EMA) had communicated just about two weeks ago in an international conference in London that misinformation is the biggest problem that they’ve had in moving biosimilars forward in Europe. So, the misinformation is something that we have to address proactively. We have to get out in front of this in terms of the education of individuals (not only physicians but payers, as well as patients) regarding the benefit of biosimilars.

Educating about biologics is critical from the first place since there is limited understanding that biologics do change over time due to changes in manufacturing. The manufacturing process is altered or changed to scale up the process or transfer it to a different manufacturing plant. There are some inherent changes in the glycosylations of the molecules on the originator. So, the original biologic molecule does vary over time and it is not identical to itself over time. In light of this, one of the pieces of misinformation is that biosimilars are not safe or they are not efficacious because they are not identical to the originator molecule. Well, the fact is that the originator molecule is not identical to itself due to the complexities of biologic manufacturing. Sandoz uses the variability of the originator molecule over the years to provide a target for us to select the product attributes of the originator molecule. We try to design our biosimilar to be as close to the originator as the originator is to itself. It is important to communicate that the biosimilar name is a regulatory term that communicates the product has the same efficacy and safety profile

So, from a communication perspective I think we just have to start at the basics and talk about the overlapping with the originator molecule and when they are approved, they are approved to have the same safety, the same efficacy as the originator molecule. In fact, the European Commission has stated previously that if they approve a biosimilar, it is as safe and as effective as any other medication that they have approved. These are the types of educational processes that we’ll have to implement.

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!

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Approved FDA User Fees for Biosimilars

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

The FDA has recently released the 2013 User Fees for Biosimilars, which outlines the fees charged to companies that are seeking FDA approval of their biosimilar therapies. The fee schedule is in effect October 1, 2012 to September 30, 2013. The sponsor is responsible for paying fees associated with biological product development (BPD) of a biosimilar product. The biosimilar biological product application fees can be either $979,440 or $1,958,800 depending upon whether clinical data is included. The fees are necessary throughout the development process so that the FDA can review applications in a timely manner

The FDA charges user fees in an effort to supplement the current budget which helps pay for the review of medical devices, drugs and now biosimilar applications. Each area has its own fees associated with reviewing applications. Charging user fees also requires the FDA to abide by time tables agreed upon by industry and the FDA in order to expedite the review of applications. The user fee system for biosimilars was adopted from the Prescription Drug User Fee Act which requires sponsors to pay fees in order to assure timely review of applications submitted to the FDA. User fees have significantly decreased the approval time for new therapies. This important for patients suffering from diseases in which these therapies are intended to treat.

The 13th Annual Biosimilars and Generic Drugs Meeting it will be important for generic drug manufacturers to share with biosimilar manufacturers the history of the user fee program and to give insight into what biosimilar sponsors will need to be aware of as they begin to secure FDA approval of a biosimilar.  For more information on the event, download the agenda.  If you'd like to join me in Boston, register today and mention code XP1786BLOG and save 25% off the standard rate!

Do you agree that the FDA should charge companies user fees? Do you think these fees will be a deterrent for some biosimilar manufacturers in these tough economic times?  Based on the current pipeline of development which sponsor do you think will secure the first USFDA approved biosimilar?

The complete FDA user fee notice can be found here.

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Biosimilars Session Spotlight: Map the Strengths, Weaknesses, & Defenses of your IP Assets to Prepare for the Challenges of the Follow-On Process

Today we feature the workshop Map the Strengths, Weaknesses, & Defenses of your IP Assets to Prepare for the Challenges of the Follow-On Process .  This in-depth workshop will offer an interactive, case-study-driven examination of the latest advances in the patent exchange process for sponsors of follow-on biologics. These legal interactions have been thoroughly described in advance, but the pathway has some potential weaknesses concerning oversight and following up on lapses. How can biosimilar sponsors best firm up these methods?

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!

Speaker Michael Castagna

Featured Workshop: Map the Strengths, Weaknesses, & Defenses of your IP Assets to Prepare for the Challenges of the Follow-On Process

Featured Presenters: Michael Castagna, Executive Director of Immunoscience, BRISTOL-MYERS SQUIBB
Mark Hyman, Assistant General Counsel, Litigation & IP, HUMAN GENOME SCIENCES

About the Workshop: Intended for IP and legal counsel marketing professionals with
an established background in either brands or biosimilars. The pathway for biosimilar approval in the U.S. depends on extremely detailed sharing of patent portfolios between biosimilar and originator companies – but so far lacks a rigid system of oversight or accountability. Instead of letting this uncertainty slow down your work, you need to learn to accommodate and work around it. This interactive and case-study-driven session will focus on preparations for the step-by-step patent analysis, challenge, and defense stage of an abbreviated biologics license application.

• • Pre-empt patent challenges by identifying your weakest links
• • Investigate and accelerate the creation of process and manufacturing patents
• • Differentiate your new follow-on product from competitors

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Biosimilars Spotlight: Are Novel Names for Biosimilars Important?

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.

If biosimilars require the use of novel names, what could biosimilar companies do to try to turn that into a marketing advantage?

Mark's Answer:

I think there were misunderstandings early on when addressing the International Nonproprietary Name or INN. Novartis was very supportive from the beginning to use the same naming convention that is currently being used with all biologics in that they would have a unique proprietary name (for example the brand name). They would also use the INN or the generic name of the original molecule. When Novartis said that we wanted to use the same INN as the originator molecule (as would be done in all other conventions), we did not imply that we would brand our products with the INN or the generic name. We are global leaders in the commercialization of biosimilars and each one of our biosimilars has a unique brand name and then has the standard INN of the originator molecule. And that’s what we have been supportive of in the US. In reality, we do support a unique proprietary name, a unique brand name, but rely on using the same INN as the originator.

Some people have spoken on this and they’ve suggested the use of a unique INN different from the originator, which would be a little bit challenging from a track and trace and from a safety perspective because doctors and patients and payers really don’t know if they are getting the same product as the originator or not. We’ve been presenting this information in a straight forward fashion to convince FDA of the wisdom of using the same naming convention that they’ve used in all other biologics.

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!

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India unveils Draft of Biosimilar Guidelines

The government of India made a surprising announcement during the Biotechnology Industry Organization (BIO) international meeting June 18-21, 2012 in Boston MA.  BIO is the annual meeting of biotechnology leaders from across the globe.  With the Supreme Court upholding the Affordable Care Act (ACA) of 2010 just days after the convention it was appropriate that India unveil its guidelines for biosimilar development at BIO 2012. The ACA included the Biologics Price Competition and Innovation Act that allow the development of biosimilars.

The guidance document released by India is entitled “Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India” and outlines the biosimilar development procedures for Indian biopharma and global players. Here is a link to the guidance documents. India is now open for business in terms of international development and commercialization of biosimilars. The guidelines allow for India to be a part of the regulated global market currently developing biosimilars. Many hope that when the US FDA finalizes the guidances for biosimilars the market will begin to grow and develop. These guidances also assure global biopharma companies that India is developing standards similar to those already established in biotherapeutic development.

What are your opinions of the guidelines as the have been released?  How do you think these guidelines will affect global biopharma development?  Do you think India will be view as potential partners or competitors to the more established biotherapeutic markets?

For more information on this topic, check out the presentation by ShinJae Chang, VP, R&D, Celltrio titled "The Strategy and Case Study of Global Biosimilar Development" at the 13^th Annual Business of Biosimilars and Generic Drugs.  For more information on this session and the rest of the program, download the brochure.  If you'd like to join us in Boston for the event, register today and mention code XP1786BLOG to save 25% off the standard rate!

Do you see reglation of biosimilars coming soon to the US market? Why or why not?

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

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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.

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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

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Biosimilars on the move in Asia

While the United States waits on the ruling of the healthcare act tomorrow, including the fate of Biosimilars in the US, from the Supreme Court tomorrow, many countries in Asia Pacific have are embracing the opportunity of biosimilars in their market.  Many of the countries in Asia Pacific have embraced this more cost effective form of treatment for their growing middle class, who often pays for health insurance out of their pockets.  Countries like China, India and Korea lead the way  in manufacturing and others including Japan, Australia, Singapore and Malaysia have regulations according to Pharma Phorum.  While many of these biosimilars companies have no experience in regulated markets, they are developing and distributing biosimilars to semi-regulated.  This gives them immense amounts of knowledge of the drugs, as the Asian biosimilars market accounts for 25% of the worldwide market.

This September in Boston, the Business of Biosimilars and Generic Drugs will hear from Andrew Shaw, Senior Director, PKDM, Mylan on the topic of globalizing generics and biosimilars.   It could be argued that America is an emerging market in biosimilars, and Shaw will be discussing that.  For more information on Shaw's presentation and the rest of the program, download the agenda here.  If you'd like to join us this September in Boston, register with code XP1786BLOG and save 25% off the standard rate.

What are the benefits of the companies operating in the semi-regulated markets to their business when they decide to expand in to a regulated market, such as the United States or Europe?

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Biosimilar Development and Commericalization

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

The global development and commercialization of biosimilars in the US, EU and the world market is closer to becoming a reality. Currently, the US does not have an approved pathway for biosimilar development.  For companies interested in taking advantage of this market it is imperative that they become familiar with the regulatory, developmental, and legal aspects of global biosimilar production in their respective markets.   The global biosimilars market is estimated to be worth  approximately 18 billion dollars by 2017.  This is due to patent expirations on several blockbuster products such as Enbrel ® (Amgen), Epogen® (Amgen), Remicade® (Janssen), and Rituxan® (Biogen Idec). These patent expirations allow for the development of cheaper versions of highly complex and effective therapies.  As a result many countries are drafting guidelines for the development of biosimilars.

The US FDA recently held public hearings with stakeholders to discuss its current version of draft guidances for the development of biosimilars.  The stakeholder community consisted of patient advocacy groups, payer groups, big pharma and biotech companies.  Participants brought up issues pertaining to biosimilarity and interchangeability, reference versus biosimilar naming and labeling, use of reference samples from non-US sources for clinical trials, and the need for specificity as to which analytical methods are required for establishing biosimilarity. Presenters also warned the FDA about the ambiguity of the first drafts of the guidance documents and requested a more detailed final draft of the guidance document.   The final version of the FDA guidances on biosimilars should be finalized soon making it possible fro companies to develop much needed therapies.

The 13^th Annual Business of Biosimilars and Generic Drugs meeting on Sept 10-12, 2012 in Boston, MA will be one of the most informative events for those entering the biosimilars market.   Many of the speakers work with global manufacturers and will address some of the most pressing issues in the market with respect to biosimilar development and commercialization.

In the weeks leading up to the  13^th Annual Business of Biosimilars and Generic Drugs meeting I will discuss topics with global implications to the development of the biosimilars market.  To find out more about this year's agenda, download it here.  If you'd like to join me, as a reader of this blog when you  register and mention code XP1786BLOG, you'll save 25% off the standard rate.

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Business of Biosimilars & Generic Drugs Session Spotlight: Outlook and Strategic Impact of U.S. Biosimilar Approval Pathway

After years of waiting, the FDA has finally released its draft guidelines for the development and approval of biosimilars. Now that the industry has a clear path forward, it is essential that you capitalize on the expert commentary of our speakers from Pfizer and Shire in order to best understand how to remain in compliance and reliably push your biosimilar candidates to the market.

Brian Harvey, Pfizer

This September at Business of Biosimilars and Generic Drugs, Brian Harvey, Vice President, U.S. Regulatory Strategy, Pfizer and Carrie Burke, Director of Government Affairs, Shire will be on hand to examine this topic in their presentation "Outlook and Strategic Impact of U.S. BiosimilarApproval Pathway" on Wednesday, September 12.  For more on this presentation and this year's event, download the brochure. If you'd  like to join us in Boston, register and mention code XP1786BLOG to save 25% off the standard rate.

Featured Session: Outlook and Strategic Impact of U.S. Biosimilar Approval Pathway
Featured Speakers: Brian Harvey, Vice President, U.S. Regulatory Strategy, Pfizer
Carrie Burke, Director of Government Affairs, Shire
About the Session: This timely session will focus on the latest updates on the
FDA’s user fee structures for biosimilars as well as their 2012 draft guidelines. The most signifi cant aspects of the biosimilar guidelines will be the allowability of foreign referent products, the assignment of unique non-proprietary names, and the extrapolation of multiple indications through shared MOA. The follow-on industry has its strong opinions on all three of these.

• • Grasp how the new legislation helps you overcome the barriers to market entry
• • Reassess your application and patent defense methods in light of the FDA’s “wall” around innovator data
• • Structure your analytical teams around the comparability methods that regulatory reviewers prefer
• • Frontload your capacity for factor certifi cation, PK studies, and other means to equate point of origin and/or functionality to regulators
• • Overcome additional roadblocks to biosimilar interchangeability at the state level
• • Strategize methods for turning unique name requirements into competitive advantage
• • Protect your budgets from any new studies that may be required if extrapolation of indications is not allowed

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Business of Biosimilars & Generic Drugs International Session Spotlight: Overview of Biosimilar Trends in BRIC Countries

As global demand for advanced therapeutics increases and more markets are newly becoming able to reimburse at least part of the costs, what commercialization, outreach, and research initiatives are you planning in order to make truly global product rollouts possible? This session will compare and contrast case studies of biosimilar sales in many different international markets, including Turkey, Mexico, Thailand, and Vietnam, in order to paint the fullest picture of the techniques you will need for global success.

This September at Business of Biosimilars and Generic Drugs, Alex Kudrin, Medical Director, Takeda Pharmaceuticals will be on hand to examine this topic in his presentation "Overview of Biosimilar Trends in BRIC Countries" on Tuesday, September 11.  For more on this presentation and this year's event, download the brochure. If you'd  like to join us in Boston, register and mention code XP1786BLOG to save 25% off the standard rate.

Featured International Session: Overview of Biosimilar Trends in BRIC Countries
Featured Speaker: Alex Kudrin, Medical Director, Takeda Pharmaceuticals
About the session: In this session, you'll learn to:

• •Anticipate how the economic growth and demand for new therapies will shape markets for biosimilars in these key new regions
• • Plan for creative and adaptable techniques to protect your IP in markets with different legal traditions and baselines
• • Design a multi-pronged approach for successful reimbursement based on government, insurance, and individual priorities and capabilities
• • Establish local partnerships to capitalize on vital trends and resources

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Don't miss the most diverse array of global case studies for the marketing of biosimilars!

Your business depends on your ability to construct a firm pathway to market-access for follow-on biopharmaceuticals - and every hour counts. With that in mind we are pleased to invite you to attend the 13th annual Business of Biosimilars and Generic Drugs – the only conference in the United States devoted entirely to giving you the tools you need for successful commercialization of biosimilars!

Our expert faculty will provide you with senior executive-level expert insight on all of your critical success factors, including regulatory approval, IP challenges, and planning and coordinating an international product rollout strategy attuned to the needs of each market.

Featured Speakers include:

• - G. Steven Burrill, CEO, Burrill & Company presenting “Think Different - Navigating the Brave New Globalized Life Science Industry”
• - Alex Kudrin, Medical Director, Takeda Pharmaceuticals presenting “Access the Emerging BRIC Markets for Biosimilars”
• - Bassil Dahiyat, CEO, Xencor presenting “Learn How to Design Profitable Strategic Partnerships for Follow-On Biopharmaceutical Development”

For more information on these case studies and the rest of the event, download the brochure here. 

The 13th Annual Business of Biosimilars and Generic Drugs will take place September 10-12, 2012 in Boston, MA. As a member of the Business of Biosimilars LinkedIn Group, you receive an exclusive discount of 25% off of the standard price when you register to join us. Simply use priority code XP1786LINK. Have any questions about the event? Feel free to contact Jennifer Pereira.

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Business of Biosimilars & Generic Drugs Session Spotlight: The New Paradigm in Strategic Partnerships for Follow-on Biopharmaceutical Development

Earlier this month, Biocon announced that it's partnership with Mylan to develop biosimilars could be worth $33 billion.  According to the Economic Times, their partnership was formed in order to develop five biosimilars drugs related to cancer an pain.  This is a similar trend emerging throughout the industry.  At the Business of Biosimilars and Generic Drugs Summit, we'll be looking at the evolving partnerships that are evolving in order to discover and develop biosimilars. For more information about the event, taking place September 10-12 in Boston, MA, download the brochure here.  If you'd like to join us, as a reader of this blog, register and mention code XP1786BLOG to save an exclusive 25% off the standard rate.

Featured Session: The New Paradigm in Strategic Partnerships for Follow-on Biopharmaceutical Development

Featured Speaker: Bassil Dahiyat, President and CEO, XENCOR

About the session: What does the recent trend of giant partnerships among biologics and generics companies foretell about the future of the industry? Is this soon to become a standard, and if so, what does your follow-on biologic company need to know and prioritize in order to choose the best partner and structure the strongest, most enduring, and most profi table coalition?

• • Applications for strategic entry into non-U.S. markets
• • Re-envisioning partnerships as a source of process patents to strengthen your product’s life cycle
• • Predict how your patent portfolio can be better protected through market consolidation

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Get the most detailed up-to-date strategies for moving your products into pharmerging markets!

Suzanne Munck, FTC

At past IIR “Generic Drug Summits”, our expert speaking faculty has always provided the most valuable event of the year in terms of sharing crucial and exclusive knowledge about the compliance and commercialization hurdles that you faced on a day-to-day basis. Now more than ever, the insight that we offer in our 13th annual Business of Biosimilars and Generic Drugs conference can help your company stay on top of the latest regulatory developments while capitalizing on new and untapped markets.

Our unequaled speaking faculty this year will provide you with the market-specific case studies and commercialization tactics that you need in order to expand your product portfolio and capitalize on growing global demand! Featured speakers include:

• - Andrew Shaw, Senior Director, PKDM, Mylan presenting “Establish R&D Methods and Timetables that will Streamline your Expansion into New Markets”
• - Abdullah Baaj, CEO, Boston Oncology presenting “Getting Global Manufacturing Processes Prepared for Product Rollouts”
• - Suzanne Munck, Chief Counsel for Intellectual Property, FTC presenting "Turn Antitrust Laws to Your Advantage in the Generics and Biosimilars Marketplace"

For more about these presentations and the rest of the program, download the brochure here.

The 13th Annual Business of Biosimilars and Generic Drugs 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 price when you register to join us. Simply use priority code XP1786LINK. Have any questions about the event? Feel free to contact Jennifer Pereira.

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Business of Biosimilars & Generic Drugs Session Spotlight: The World is Flat—Make Sure Your Sales Are Not—Commercializing Generics in Global and Emerging Markets

The United States and European markets are redically different when it comes to the approval and use of biosimilars.  New guidelines from the FDA in the United States should make could soon make it easier to bridge the gap and identify the market.  Not only will there be an emerging market for biosimilars in the United States, but around the world.  At Business of Biosimilars and Generic Drugs, we will help you identify emerging markets for your follow-on products: both in developing countries with populations that have just gained the capacity to purchase pharmaceuticals, and the U.S. and Europe where you can capitalize on new opportunities for generic / biosimilar versions of established drugs. It will give you the skills to match the needs of each unique market segment while answering any of their concerns about product effectiveness, quality, or point of origin.

For more information about The Business of Biosimilars and Generic Drugs taking place September 10-12, 2012 in Boston, MA, download the brochure.  As a reader of this blog, when you regsiter to join us today and mention code XP1786BLOG, you'll receive a discount of 25% off the standard rate!

Featured Session: The World is Flat—Make Sure Your Sales Are Not—Commercializing Generics in Global and Emerging Markets

Featured Speaker: Andrew Shaw, Senior Director, PKDM, MYLAN

About the session: Identify growing markets (with a particular emphasis on Latin America, Asia, and MENA) to which your business plans can adapt fastest:

• - Tactics for reassuring new audiences about the suitability and acceptability of your product
• - Choosing and training regional partners required for formulation, manufacturing, and distribution
• - The U.S. as an ‘emerging’ market – focus on new methods for branded generics and facilitated reimbursement that can find new profit sources

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Current State of Biosimilars in the United States

The FDA has had the regulations to approve biosimilars in place for two years.  Yet, as Pharmalot points out, it is yet to receive an application for approval. Gillian Woollett, a vice president at Avalere Health, a healthcare consulting firm, took some time to share her views on the current state of biosimilars.  She points out that there are 149 biologics approved for use in the United States and over 900 are in clinical development.  Those who take the biologics on a daily basis pay about $22 a day.  The market is expected to reach $150 billion by 2016.  It costs $250 million to develop a biosimialr.  So does this open the door for biologics in the US?

In Europe, there are already 14 biosimilars approved and on the market, many out sell their originator biologics.  However, Woollett is quick to point out that in the EU, the EMA doesn't give complete interchangeability to biologics and biosimilars.  The United States FDA does have this ability.  But at the end of the article, Woollet points out that the approval is ultimately about the patient, and many things will be determined by how much the biosimilars will cost who will be paying for it.

At the Business of Biosimilars & Generic Drugs this September, Hoss Dowlat, Vice President, Regulatory Affairs, PHARMA-BIO CONSULTING will be on hand to present "Experiences from Developing Biosimilars for EMA: Unique Perspectives from Growth Hormones to Monoclonal Antibodies,"looking at how the US and European markets may differ and how to coordinate a roll out between the two markets.  To find out more about this session and the program, download the brochure here. If you'd like to join us this September 10-12 in Boston, register today and mention code XP1786BLOG to save 25% off the standard rate.

Do you believe we'll see a biosimilars presented for approval in the US in the next year? Why or why not?

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Business of Biosimilars & Generic Drugs Session Spotlight: Think Different—Navigating the Brave New Globalized Life Science Industry

Steve Burrill is one of the most influential and trusted experts and advocates in the biotech industry, bringing over 40 years of experience with him. He has helped establish and grow many companies and stewarded the development of major strategic partnerships. This year at Business of Biosimilars & Generic Drugs, talk he will be discussing the new paradigm of organizational partnerships required for biosimilar development, approval, and commercialization, as well as how the industry must respond to regulatory change in order to grow.

For more information on Steve's presentation and the rest of  the 13th Annual Business of Biosimilars & Generic Drugs taking place September 12-14, 2012 in Boston, MA, download the agenda here.  As a reader of this blog, when you register to join us and mention code XP1786BLOG, you'll receive a discount of 25% off the standard rate.

Featured Session: Think Different—Navigating the Brave New Globalized Life Science Industry
Featured Speaker: G. Steven Burrill, CEO, BURRILL & COMPANY
About the session: G. Steven Burrill is one of the biotech industry’s greatest icons and advocates, with over 40 years of experience in guiding biotech firms towards greater growth, adaptability, and success. Now in the face of dramatic new regulatory changes and a shaky global economy, Mr. Burrill will help you focus on the key factors now impacting follow-on biologics and guide your company towards long-term staying power.

• • Strategic partnerships and acquisitions for biosimilar development: how big is this trend, and how can you take advantage if you aren’t already?
• • Healthcare reform in an election year: make sure that whoever loses in November, you win
• • Outlook and options for reimbursement amid economic uncertainty and global competition

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