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Biosimilars Law Blog

Tag Archives: FDA Biosimilars Guidances

Posted in News & Events

FDA Anticipates New Draft Biosimilar Guidances

Including biosimilars in the release of expected 2014 CDER draft guidance documents has sparked the public interest as industry, physicians, patients and others await additional cues on FDA’s implementation of the BPCIA.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

Posted in News & Events

Europe approves its first mAb biosimilar & FDA is handling 17 biosimilar INDs

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

Posted in Biosimilars vs. Generics

GPhA Petitions FDA Not to Distinguish Biosimilars by Unique Non-Proprietary Names

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

Posted in Biosimilars Patent Exchange, News & Events

Universities urge FDA to require certification of information exchange for biosimilar applications

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

Posted in News & Events

Biosimilars: Who’s Who at FDA?

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

Posted in News & Events

Public Comment on FDA Draft Biosimilars 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