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 Register, FDA has opened a dedicated docket for each guidance:
- Docket No. FDA–2011–D–0611:Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
- Docket No. FDA–2011–D–0602: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product
- Docket No. FDA–2011–D–0605 : Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.
FDA will accept comments to these dockets until April 16, 2012.
As the agency acknowledges in the Federal Register notices, FDA regulations allow the public to comment at any time on any guidance. 21 CFR 10.115(g)(5). Nevertheless, we expect that all three of the guidance dockets will see a significant amount of input from industry stakeholders and all other interested persons.
With regard to the Q & A Guidance, FDA has also announced that:
“FDA intends to update this guidance to include additional Q&As as appropriate and intends to post information by Q&A number on FDA’s Web site regarding the publication date of draft guidance Q&As for comment, the comment period, and the publication date of final guidance Q&As.”
77 Fed. Reg. 8885, 8886 (February 15, 2012). We will update you as soon as FDA issues any further draft Q&As for comment or finalizes any of the recently proposed ones.