ADVERTISEMENT
2 /3 FREE ARTICLES LEFT THIS MONTH Remaining
Chemistry matters. Join us to get the news you need.

If you have an ACS member number, please enter it here so we can link this account to your membership. (optional)

ACS values your privacy. By submitting your information, you are gaining access to C&EN and subscribing to our weekly newsletter. We use the information you provide to make your reading experience better, and we will never sell your data to third party members.

ENJOY UNLIMITED ACCES TO C&EN

Policy

Senators Clarify Biosimilars Law

by Britt E. Erickson
January 17, 2011 | APPEARED IN VOLUME 89, ISSUE 3

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.”

X

Article:

This article has been sent to the following recipient:

Leave A Comment

*Required to comment