Regulatory Beat: Campaign Heats Up for Follow-On Biologics - Action by FDA and Congress seeks to clarify manufacturing and testing requirements for less costly "comparable" biopharmaceuticals. - BioPh


Regulatory Beat: Campaign Heats Up for Follow-On Biologics
Action by FDA and Congress seeks to clarify manufacturing and testing requirements for less costly "comparable" biopharmaceuticals.

BioPharm International
Volume 19, Issue 12


In explaining its action on Omnitrope, FDA reiterated its request for new legislation to clarify its legal authority to approve follow-on versions of any biotech therapies. Just before Congress recessed in October, three leading Democratic legislators offered a proposal to move the debate forward. Rep. Henry Waxman of California and Sens. Charles Schumer and Hillary Rodham Clinton of New York introduced the "Access to Life-Saving Medicine Act" (HR 6257) that describes an approach for approving copies of biopharmaceuticals. Although the legislators acknowledge that more complicated scientific issues are involved in demonstrating that a generic version of a biotech drug is the same as the branded product, they assert that the Omnitrope approval shows that this approach is "scientifically feasible."

The bill authorizes FDA to approve abbreviated applications for biological products that are "comparable" to previously approved biologics. FDA will determine on a case-by-case basis what clinical and preclinical studies are necessary to establish comparability, and all applications for follow-on biologics would pay user fees.

A summary of the bill points to the importance of documenting comparability with extensive technical and scientific knowledge. A comparable product has to share the "principal molecular structural features" and have the same mechanism of action (if known), route of administration, dosage form and strength. Manufacturing controls must assure product identity, strength, quality, and purity.

The legislation also encourages manufacturers to conduct additional testing to demonstrate that a product is interchangeable with the reference product, instead of just comparable. Interchangeable products would produce the "same clinical result(s)" as a reference product. Because clinical testing would be required, the bill offers manufacturers tax credits to cover the extra studies, plus six months exclusivity for the first applicant that establishes interchangeability.

The bill aims to prevent innovator firms from maneuvering to extend patents and block new follow-on products from market; there will be no authorized generics by brand firms during the exclusivity period and curbs on frivolous citizens petitions. The measure also seeks to resolve patent disputes early on by establishing a new patent listing and notification procedure.

Because follow-on biologics would be more difficult and time-consuming for FDA to assess and approve, the bill boosts FDA resources by establishing user fees for follow-on biologics applications, a move that may set a precedent for the generic drug industry overall. Generic drug manufacturers are the only drug industry segment that do not have to ante up to file applications or support FDA oversight of marketed products. The issue has been discussed for years, and the current squeeze on FDA resources puts these issues on the table for negotiation as part of the debate on the renewal of the Prescription Drug User Fee program (PDUFA) in the coming year.

Jill Wechsler is BioPharm International's Washington editor, 7715 Rocton Avenue, Chevy Chase, MD 20815, 301.656.4634,

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