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Biosimilars Law Blog

Tag Archives: Biologics Price Competition and Innovation Act of 2009

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 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

Awaiting FDA Guidance on Interchangeability for Biosimilars

The three draft Guidances recently released by the U.S. Food and Drug Administration on implementation of the Biologics Price Competition and Innovation Act of 2009 focus on how to demonstrate biosimilarity but don’t say much about demonstrating interchangeability.  FDA has asked for stakeholder input on biosimilar interchangeability at the agency’s upcoming one-day public hearing on

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 Global Comparisons

EMA regulatory approval changes for biosimilars on the horizon in the E.U.?

As mentioned in a previous post, the EMA set the standard for regulatory approval of biosimilars* with the adoption of their overarching general guideline in 2005 (CHMP/437/04 — PDF), followed shortly thereafter by guidelines on quality issues (EMEA/CHMP/BWP/49348/2005 — PDF) and on non-clinical and clinical issues (EMEA/CHMP/BMWP/42832/2005 — PDF). The pathway for biosimilar approval was