Generic Competition in the Biopharmaceutical Industry

Date change: October 6th was selected instead of October 8th in order to accommodate our members who celebrate Yom Kippur.
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Follow-on Biologics (FOB’s) are generic versions of innovator biologic therapeutics to include recombinant proteins and antibody therapeutics. An abbreviated scheme for their approval in the US is currently under intense discussion and meticulous review in Congress and heavy debate among innovator and generic manufacturers.

An accelerated approval process for FOBs is associated with complex scientific, commercial, financial, and legal implications when compared to small molecule (and biologic) generics approved under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA) . Congress has acknowledged these complexities as evidenced by their solicitation of the advice from both biopharmaceutical and generic manufacturers, in addition to regulatory bodies to include the US Food and Drug Administration, US Federal Trade Commission, Centers for Medicare and Medicaid, and the EMEA. Subsequently, innovator biopharmaceutical manufactures, which face potential generic challenge to their biologic annual revenues totaling billions of US dollars, are currently engaged in intense debate with generic manufactures regarding provisions for an ANDA for FOBs.

In this seminar, Carl D.Rios and Mitchell Wong will provide a top-level review of the heavily debated complexities and implications of an abbreviated pathway for Follow-on Biologics to include manufacturing and clinical challenges, financial impact of competition to manufacturer and consumers, potential changes to regulatory exclusivity and patent litigation.

Learning Objectives:

Consider molecular differences between generic versions of small molecule drugs and biologics and the challenges these differences present to FOB production.

Review current abbreviated approval pathway and regulatory exclusivities for small molecules generics (and some biologics) in the US and consider their applicability to FOBs in light of EMEA’s abbreviated pathway.

Understand the debate surrounding FOBs and impact of FOBs to biopharmaceutical and generic manufactures, regulatory agencies, payors and consumers.

Bios:
Mitchell M. Wong, Esq., is a patent litigator at Morrison & Foerster LLP, where he litigates and advises clients on biotechnology and Hatch-Waxman issues. Mitchell received his B.A. from Columbia College and his J.D. from the Cornell Law School. He then served as a law clerk to the Honorable Andrew J. Kleinfeld of the U.S. Court of Appeals for the Ninth Circuit.

Carl D. Rios, Ph.D., is a Medical Science Liaison at Amgen Inc. and supports the Nephrology Therapeutic Area scientific platforms aligned to three therapeutic franchises, as well as supports clinical-level post-marketing and pipeline development. Carl's educational background includes post-graduate studies at Weill-Cornell Medical College and New York University.