Senators Clarify Biosimilars Law

In a Jan. 7 letter to FDA Commissioner Margaret A. Hamburg, Sens. Michael B. Enzi (R-Wyo.), Kay R. Hagan (D-N.C.), Orrin G. Hatch (R-Utah), and John F. Kerry (D-Mass.) reminded the agency that the Biologics Price Competition & Innovation Act does not provide 12 years of market exclusivity for innovator biological drugs. The act “provides data exclusivity, which prohibits FDA from allowing another manufacturer of a highly similar biologic to rely on the Agency’s prior finding of safety, purity and potency for the innovator product,” the senators wrote. “It does not prohibit or prevent another manufacturer from developing its own data to justify FDA approval,” they clarified. The senators also pointed out that the law prohibits “any product from being granted more than one period of data exclusivity.” The lawmakers sent the letter in response to a question posed by FDA in a public hearing notice that stated biologics “may be eligible for a second 12-year period of marketing exclusivity.”