Over the past few years, several forces have begun to converge that will likely shift the entire biomarket’s dynamics. Patents of top-selling biotechnology products have lost or will lose patent protection in the next half dozen years. A variety of legal and legislative moves are focusing on the regulation of biogenerics. And companies at the forefront of these changes are creating the pathways that others could follow.
In June 2007, the Senate approved the Biologics Price Competition and Innovation Act of 2007 (S. 1695), which would establish a pathway for the licensure of biosimilar biological products. This follows an effort in the U.S. House of Representatives by Henry Waxman in late September 2006, who introduced H.R. 1038, the Access to Life-Saving Medicine Act, which would allow abbreviated biogeneric applications based on BLA-registered reference products. The bill was reintroduced in February 2007 as an amendment to the PHS Act, which would provide two regulatory designations for biogenerics: “comparability” or “interchangeability”…
Timeline of Biogenerics Commercialization Milestones
Patent and Exclusivity Expirations of Key Biologics
Experts on this Topic
Steven B. Brugger. Senior VP, Strategic Business Operations, Momenta Pharmaceuticals Inc., Cambridge, Mass.; Momenta is a biotechnology company specializing in the detailed structural analysis and development of complex mixture drugs. For more information, visit momentapharma.com.
Troy Hampton. Senior Practice Executive, Managed Markets Practice, Campbell Alliance, Raleigh, N.C.; Campbell Alliance is a management consulting firm specializing in the pharmaceutical and biotech industries. For more information, visit campbellalliance.com.
Ajaz S. Hussain, Ph.D. VP and Global Head of Biopharmaceuticals Development, Sandoz Pharmaceuticals, Princeton, N.J.; Sandoz is a division of Novartis Pharmaceuticals that develops, manufactures, and markets off-patent medicines, as well as pharmaceutical and biotechnological active ingredients. For more information, visit sandoz.com.
Audrey Phillips, Ph.D. Executive Director, Biopharmaceutical Public Policy, Johnson & Johnson Pharmaceutical Services LLP, New Brunswick, N.J.; Johnson & Johnson is a comprehensive and broadly based manufacturer of healthcare products, as well as a provider of related services, for the consumer, pharmaceutical, medical-device, and diagnostics markets. For more information, visit jnj.com.
William B. Schultz. Partner, Zuckerman Spaeder LLP, Washington, D.C.; Zuckerman Spaeder is a law firm whose FDA practice represents individuals, generic, and small biotechnology companies, state governments, associations, and advocacy organizations before the courts, government agencies, and Congress. For more information, visit zuckerman.com.