FDA has announced the opening of a docket (FDA-2016-N-2610) for interested parties (academic researchers, regulated industries, consortia, patient groups, etc.) to submit suggestions, recommendations and comments on a list of biomarkers that were used as outcomes to develop FDA-approved new molecular entities and new biological therapeutics from October 2007 to December…
Today FDA announced that it will hold a public meeting on October 20, 2016 to discuss its proposed recommendations for the reauthorization of the Biosimilar User Fee Act, which permits FDA to collect fees and use them for the process for the review of aBLAs. The current legislative authority for BsUFA…
The FDA has announced the rates for biosimilar user fees for the 2017 Fiscal Year: FY17 BsUFA Fees Biological Product Development Initial $203,810 Annual $203,810 Application w/Clinical Data $2,038,100 w/o Clinical Data $1,019,050 Supplement w/Clinical Data $1,019,050 Product $97,750 Establishment $512,200 Reactivation $407,620 The biosimilar user fees for a given fiscal year…
The FDA has extended the public comment period for its draft guidance “Labeling for Biosimilar Products: Guidance for Industry” by 60 days, to August 2, 2016: https://www.federalregister.gov/articles/2016/06/06/2016-13223/labeling-for-biosimilar-products-draft-guidance-for-industry-availability-extension-of-comment
The FDA recently requested comment on its draft guidance for implementation of the “deemed to be a license” provision as described in section 7002(e) of the Biologics Price Competition and Innovation Act of 2009 (“BPCI Act”). Section 7002(e) addresses the circumstances under which an application filed under section 505 of…
In a recent meeting, the FDA proposed modifications to the application review process for possible implementation into the Biosimilar User Fee Act (BsUFA). These modifications included establishing a review model similar to “the Program” initiated under the Prescription Drug User Fee Act (PDUFA). Highlights include a mid-cycle communication, a late-cycle…
On September 17, 2015, Janet Woodcock, M.D., the director of the FDA’s Center for Drug Evaluation and Research, testified at a congressional hearing on the topic of biosimilars. A link to her written testimony is provided here, and a link to the video of the Q&A session is provided here….
In April 2015, the FDA released three updated non-binding guidances regarding the process for biosimilar approval under section 351(k) of the Public Health Service Act (“PHS Act”) as amended by the Biologics Price Competition and Innovation Act of 2009. These publications, Biosimilars: Questions and Answers Regarding Implementation of the Biologics…