FDA Schedules Meeting on Biosimilars

BOSTON (TheStreet) -- The U.S. Food and Drug Administration is scheduling a public hearing in November to discuss the development of copycat versions of biotech drugs, according to a draft notice of the meeting being circulated by the regulatory agency.

The proposed public hearing is another signal that FDA is moving deliberately towards creating a regulatory framework to foster new, lower-priced competition to the biologic drugs that are the growth engines of biotech companies like Amgen(AMGN) , Biogen Idec(BIIB) , Genzyme(GENZ) and others.

The FDA's two-day meeting on so-called biosimilar drugs will be held Nov. 2-3, according to a draft Federal Register notice titled "Approval Pathway for Biosimilar and Interchangeable Biological Products."

FDA has yet to formally announce the meeting, but the draft agenda has been circulating around Washington, D.C., according to health policy analyst Alec Vachon, who disclosed the FDA's plans Friday on Twitter.

The healthcare reform bill passed earlier this year by Congress gave FDA permission to approve biosimilars, which are copies of large protein, or biologic, drugs made in cultures of living, genetically altered cells. Biologic drugs are notoriously hard to manufacture, so until now, they've been exempt from federal law that allows for the manufacture of low-cost copies of small molecule, or chemical, drugs once the patents protecting their intellectual property expires.

Generic copies of chemical drugs are considered to be identical to their brand name counterparts and existing law allows doctors and pharmacies to substitute one for the other freely.

Biologic drugs, however, are complex proteins so copycat versions may be "similar" but not completely identical or have the same efficacy and safety profile. While FDA now has the authority to approve biosimilars, the agency has struggled so far to come up with clinical testing standards to ensure that patients treated with biologic copies receive the same benefits while not being put at any greater risk.

"The Food and Drug Administration (FDA) is announcing a 2-day public hearing to obtain input on specific issues and challenges associated with the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act)," states the agency's draft Federal Register notice, referring to the law which authorizes the approval of biosimilars.

"We believe the primary focus might be to better define what terms in the bio-similar legislation actually mean and to clarify exactly what the approval criteria will be for generics companies to secure true 'interchangeable' status," said ISI Group biotech analyst Mark Schoenebaum, in a note to clients Sunday.