US biosimilars bill to grant 14.5 years of exclusivity

Under the Biosimilars bill introduced in the House on March 13, 2008, innovators would receive a minimum of 12 years of marketing exclusivity for a novel biological and could earn an additional two years if they received approval for a medically significant new indication within eight years following initial licensure. Sponsors could receive an additional six months of protection in exchange for conducting paediatric trials.

The bill introduced by the California Democrat Anna Eshoo and Texas Republican Joe Barton prioritizes the role of FDA in the biosimilar approval process. The Biologics Price Competition and Innovation Act permits the FDA to approve biosimilars that are interchangeable.

The bill drew immediate flake from the Generic Pharmaceutical Association (GPhA), which contended that the bill laid more emphasis on brand company profits rather than the patient needs. But the innovators group BIO welcomed the bill with some reservations.

Kathleen Jaeger, president and CEO of GPhA, said: “This new bill, at best, is a disappointing distraction that does nothing to advance legislation. The proposal creates a pathway filled with roadblocks to access, including an unjustifiable 14.5 years of market exclusivity beyond the years companies already have under their existing patents.”