Save the date for IIR’s 14th Annual Biosimilars Event!

No other event provides the business know-how of getting biosimilars to market quickly and efficiently.Through a multidisciplinary approach of competitive intelligence, regulatory strategy, bioanalytical comparability, clinical development and more, IIR’s industry-leading 14th Business of Biosimilars provides insight from market leaders on choosing the best pathway for a Biosimilar product.

Why you should attend:

 • NEW! Pre-conference workshop—Understanding the Nuts and Bolts of Biosimilar Regulatory Requirements
• NEW! Point-counterpoint talks deliver both the Biosimilar and Brand perspectives on hot policy topics
• Navigate the EMEA approval pathway for monoclonal antibodies
• Conduct structural and PK/PD comparability assessments
• Overcome the science and complexity of indication extrapolation
• Define the role of higher order structure in fingerprinting
• Analyze current biosimilar market trends and future challenges
• And more!

Hear executive-level expert insight on critical Biosimilar success factors from:

• Mark McCamish MD, PhD, Head Global Biopharm. Development, SANDOZ INTERNATIONAL GMBH
• Michael Malecki,Director, Regulatory Policy, AMGEN
• Bruce A. Leicher,Senior Vice President and General Counsel, MOMENTA PHARMACEUTICALS
• Dr. Michel Mikhail, Chief Regulatory Officer & Executive Vice President Global Regulatory - Governmental Relations,FRESENIUS KABI
• Dr. Duncan A. Emerton, Biosimilars Practice Lead, DATAMONITOR HEALTHCARE CONSULTING
• Naomi Pearce,VP, IP Counsel and Director, Global Biologics COE, MYLAN
• Erika Lietzan, Partner, COVINGTON & BURLING LLP
• Paul Greenland,Vice President—Biologics, HOSPIRA UK LIMITED
• Magdalena Leszczyniecka PhD MBA, President and CEO, STC BIOLOGICS, INC.
• Bob Ward, VP, Head of Strategy & Alliances, New Opportunities,ASTRAZENECA
• Elizabeth Jex, Attorney Advisor, Office of Policy Planning, FEDERAL TRADE COMMISSION
• Wenyan (David) Shen,VP, Global Head of Biologics Development, TEVA

Stay Tuned! We are currently in the process of finalizing the speaking faculty as well as the event website. Be sure to check out our website for more information.
Best,
The Biosimilars Team

Biosimilars Homepage
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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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New biosimlars report looks at commercial aspect

Industry Standard News has a new report titled, "The Prescribing Outlook for Biosimilars." In creating this report, researchers talked to physicians about safety, efficacy, pricing and other critical characteristics when it came to prescribing these drugs.

According to Kevin Olson, President, ISR,
“Because there is no regulatory pathway for approval of these products in the United States, the body of writing on this topic focuses either on the development of biosimilars or on the implications for approval of the products after development. We believe that drug developers and their partners in commercial divisions should also understand what adoption of these products may look like as it may have implications for development strategy and will certainly impact a product’s commercialization strategy. For example, we found that over half of the respondents believe that regulatory authorities should require full-fledged clinical trials for biosimilars as a condition of approval. This was true among both U.S. prescribers and E.U. prescribers and is an indication of prescribers’ levels of comfort with the products.”

Read the full article and find out more about the report here.

IIR’s 2nd Annual Business of Biosimilars conference delivers effective strategies to navigate scientific, regulatory, economic, and legal challenges you face to remain competitive in commercializing your biosimilar portfolio in the United States and abroad.

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Biosimilars White Paper: Panacea or Poison Pill? Making Sense of the New Biosimilars Law

I recently came across the BNA, Inc. white paper "Panacea or Poison Pill? Making Sense of the New Biosimilars Law." It takes an in-depth look at the new healthcare reform that allows the streamline development and FDA approval pathway for biosimilars.

According to the paper:

This article provides a brief overview of the history leading up to passage of the Biosimilar Act, discusses in detail both the FDA regulatory and patent litigation provisions of the act (with comparisons and contrasts to the Hatch-Waxman scheme), probes potential interpretations of key provisions, and offers practical strategic considerations both for companies seeking to pursue product approvals under the new law, and for companies whose products now may face increased competition from follow-on products.

Read the white paper here.

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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.

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Biosimilars to transform the competition

At Medical, Marketing & Media, they look at how the new approval pathway for biologics will not only increase the marketing for the biosimilars but the biologics as well. Follow-on Biologics will change the shape of the market, as they will be more than just a generic. While biologics will have market exclusivity for 12 years, once a follow-on biologic is on the market, prices for these are only expected to be 20-30% lower.

Do you expect the marketing for biologics to change once they face competition from biosimilars? Read more about this topic at MM&M.

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Biosimilars could help healthcare costs

Sam Taylor, the president of the North Carolina Biosciences Organization and James C. Greenwood, President and CEO, Biotechnology Industry Organization recently wrote an opinion piece about how the approval of a pathway for biosimlars, which could help tremendously when it comes to healthcare and reducing the costs of both medicine and care.

The letter states:
Done correctly, an approval process for biosimilars will protect patient safety, expand competition to reduce costs for consumers, and provide fair incentives for continued biomedical innovation.

As well as:
In considering biosimilars legislation, Congress must maintain incentives for continued investment in order to realize the full potential of this sector to provide new therapies and even cures to patients.

Read the full article here.

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

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Biosimilars: time for an approval pathway in the US

Congress has received another bill seeking to establish a biosimilars approval pathway in the US.

HR 1427 represents the latest attempt to secure legislation for a biosimilars approval pathway in the US. With a five year exclusivity period, the proposed bill will be viewed as pro-biosimilar and could therefore face considerable opposition from prescription drug manufacturers. However, given the escalating cost of healthcare in the US, the industry is under pressure to find a solution.

Escalating healthcare costs, driven by the increased use of biological therapies, has prompted a team of US congressmen led by Representative Henry Waxman to submit yet another biosimilars bill to Congress. HR 1427, the Promoting Innovation and Access to Life-Saving Medicine Act, is the latest in a series of similar bills proposed to Congress, all of which have failed. Through the bill, the team (which also includes Representatives Frank Pallone, Nathan Deal and Jo Ann Emerson) hopes to secure legislation for a biosimilars approval pathway in the US. HR 1427 is seen as a key step in President Obama's strategy of lowering the cost of biopharmaceuticals and making healthcare affordable to all.

HR 1427 would provide the FDA with the necessary authority to approve abbreviated applications for biosimilar products, an authority which the European Medicines Agency (EMEA) has had since 2006. Critical to this is that applicants must prove to the FDA that there are no clinically meaningful differences between the biosimilar and the reference product via clinical trials. Under the terms of the bill, the FDA would have scientific discretion to determine which studies would be necessary to prove the safety and efficacy of biosimilars

In comparison with other bills, HR 1427 is pro-biosimilar, with a five year exclusivity period consistent with the Hatch-Waxman Act. Extensions to this are possible, particularly when new indications are approved, but this period of exclusivity is likely to provoke stern opposition from prescription drug manufacturers. Three other bills currently being reviewed by Congress call for exclusivity periods of 12 to 15 years, which would give innovator companies ample time to recoup their investments.

With a new president in the Whitehouse, Big Pharma warming to the concept of selling biosimilars and healthcare costs escalating at a staggering rate, the time for compromise and progress may be here. As one industry trade group representative commented after the publication of the new bill, "We all have a common interest in establishing a responsible pathway."

Related research

Biosimilars Series: Stakeholder Analysis - A Panoramic View of the Emerging Biosimilars

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