As biosimilar applications begin rolling in, FDA has issued two of its 2014 “promised” guidances, addressing important issues of how the agency is implementing the BPCIA: (1) what information FDA will consider to determine “first licensure” for a biologic licensed under 351(a), which is essentially a decision on eligibility for the 12-year exclusivity period provided to new biologics; and (2) regulatory expectations for clinical pharmacology in support of a biosimilar application.
Including biosimilars in the release of expected 2014 CDER draft guidance documents has sparked the public interest as industry, physicians, patients and others await additional cues on FDA’s implementation of the BPCIA. The Center for Drug Evaluation and Research’s 2014 agenda for new and revised draft guidances includes the following for Biosimilars: Biosimilars: Additional Questions
Not surprising after the European Medicines Agency (EMA) positive opinion for two biosimilars to Remicade (infliximab) in June, the first of these was authorized in September. Authorization of Remsima represents the first monoclonal antibody biosimilar, and the thirteenth biosimilar, authorized in the European Union. In the United States, the Food and Drug Administration is into
The Generic Pharmaceutical Association requests that the U.S. Food and Drug Administration assign the same non-proprietary name to a biosimilar as the one held by its reference biologic. FDA has not articulated a policy for naming of biologics, biosimilars and interchangeable biosimilars, although they asked for input on the topic in the Public Meetings and
A collection of associations for higher education wrote to FDA Commissioner Margaret Hamburg urging a requirement for biosimilar applicants to certify that they have complied with the information exchange and patent dispute resolution provisions of the BPCIA. The concern raised is that: “biosmilar sponsors can effectively circumvent every patent litigation provision of the statute simply
The usual suspects from regulated industry, patient and physician groups turned out for the U.S. Food and Drug Administration’s public meeting on the biosimilars guidances. Now that the draft guidances have been out for several months and the FDA has a stack of comments to consider, the dialogue has moved from the theoretical to the
According to several recent presentations by U.S. Food and Drug Administration (FDA) officials, the agency has established three committees charged with discussing and coordinating issues related to biosimilars to ensure consistency in the regulatory approach and guidance to sponsors. While FDA set up this infrastructure some time ago, with the issuance of the Draft Guidances
Thoughts on the U.S. Food and Drug Administration’s recently issued biosimilar guidance documents? The time to act is now. As described in our earlier post , FDA must provide the public an opportunity to comment on the three recently issued biosimilars draft guidances. 42 USC 262(k)(8)(B)(i). As described in the announcement notices in the Federal