The FDA recently requested comment on its draft guidance for implementation of the “deemed to be a license” provision as described in section 7002(e) of the Biologics Price Competition and Innovation Act of 2009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 24, 2015, the United Kingdom’s National Health Service (NHS) released a biosimilars guidance document, available here. In it, the NHS bans automatic substitution of biosimilars, meaning that pharmacists may not switch between biosimilars and reference biologics, or between one biosimilar and another, without the consent of the prescribing…
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…