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… Continue Reading
Tag Archives: 351(k) pathway
Making U.S. Biosimilars a Reality – Everyone Seeks Clarity and Direction from FDA
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… Continue Reading
SCOTUS review of the Patient Protection and Affordable Care Act and “the biosimilar thing”
While a Supreme Court ruling on the constitutionality of the healthcare reform law is not expected until June, sponsors and regulators continue to lay the groundwork for biosimilars in the U.S. An unintended consequence of embedding the Biologics Price Competition and Innovation Act within PPACA without a severability clause leaves the biosimilars law vulnerable to… Continue Reading
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… Continue Reading
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… Continue Reading
Biosimilars, biosimilarity—what does ‘highly similar’ mean?
It is largely up to the FDA. In the U.S., what constitutes “highly similar” in the context of biosimilars is ultimately up to how the U.S. Food and Drug Admininstration applies the statutory language under the Biologics Price Competition and Innovation Act of 2009 (PDF). Demonstration that a biological product is “highly similar” to its… Continue Reading