Understanding the U.S. Biosimilar Pathway in 2012 An In-Depth Look at the Debate and Its Implications
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After years of talk, the FDA has finally released its roadmap for biosimilars development. And while the guidances are the start of the often mentioned “roadmap” — they’re no GPS.
Confusion still abounds among drug and biologics makers, CROs and CMOs. The FDA’s proposed risk-based totality-of-the-evidence approach raises the regulatory bar to unexpected heights.
Already scratching your head and re-thinking your strategy? You’re not alone. Read on for the most up-to-date intel in the market…
The global market for biosimilars is exploding. Biologics are the top-selling medicines in the U.S. and 90% growth is predicted.
But in order to succeed you must be prepared and understand what the FDA expects, how they want your applications submitted and why your product deserves approval.
On Feb. 9, the FDA threw open the floodgates, issuing three draft guidances that promise to provide a roadmap for biosimilars development. And they opened up a public comment period that generated some serious discussion.
FDAnews called on two experts in regulatory law, Covington & Burling’s Erika Lietzen and Laura Sim, to explain what the FDA is trying to do, how the public comments might change the landscape and what you need to know NOW in order to stay out in front.
In just 90 minutes, you’ll dig deep into fine points like these, and more: If a protein is made via a completely different process than the reference product, is the patent infringed? How does the addition of the word “protein” to the PHSA definition of biologics affect the definition of “biological” and “biosimilars” under BPCIA? How does one identify the “reference” product and prove biosimilarity?
Among specific discussion topics:
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Overview and analysis of Title VII of the Patient Protection and Affordable Care Act (PPACA, P.L. 111-148), i.e., Biologics Price Competition and Innovation Act of 2009 (BPCIA)
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Review of the FDA’s draft guidances and industry comments
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Overview of the European Medicines Agency biosimilar submissions guidance
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Clarifying the new meaning of biosimilar pathway vs. 505(b)(2) and BLAs
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Examining the effect of this abbreviated approval pathway on innovation — how brand name and generic companies might be affected
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Exploring interchangeability requirements
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How will biosimilars fit in with life cycle strategies?
- targeting R&D efforts
- re-examining prosecution efforts
- anticipating vulnerable patents and litigation
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And much more
Meet Your Instructors
Erika Lietzan is a partner at Covington & Burling specializing in U.S. and international regulation of drugs and biologicals. Her expertise includes the law of biosimilars; Hatch-Waxman; BPCIA; data and market exclusivities; WHO initiatives; health outcomes and comparative effectiveness research; supply chain issues including counterfeiting, importation, pedigrees, and online pharmacy; drug safety issues including risk management and pharmacovigilance; and interactions with healthcare professionals including samples, grants, advertising/promotion and the PhRMA Code. Previously she served as Assistant General Counsel of PhRMA and chair of the American Bar Association’s Biotechnology Committee. She is a member of the FDLI Board of Directors and the American Law Institute.
Laura Sim is an associate in Covington & Burling’s Food & Drug practice group. She advises drug, biologic, device and food manufacturers on a range of regulatory and consumer protection issues involving the FDA, USDA and Consumer Product Safety Commission.