On August 8, 2017, Sanofi-Aventis (“Sanofi”) filed a patent infringement suit in the United States District Court for the District of New Jersey against Merck Sharp & Dohme (“Merck”) for infringement of U.S Patent Nos. 7,476,652 and 7,713,930. The suit relates to Merck’s insulin glargine vial drug product, a proposed follow-on biologic of Sanofi’s Lantus.
The U.S. Senate passed S.934 – FDA Reauthorization Act of 2017 on Thursday, August 3, 2017, by a 94-1 vote after having been passed by the House last month, as reported here. The President immediately signed it into law.
As we previously reported, the Biosimilar User Fee Act “BsUFA II” portion of the FDA
H.R.2430 – FDA Reauthorization Act of 2017, a bill reauthorizing all of the U.S. Food and Drug Administration (“FDA”) user fee programs, including reauthorization of the Biosimilar User Fee Act (“BsUFA II”), was passed in the House of Representatives on July 12, 2017, with bipartisan support by voice vote. The House bill comes as
The Biosimilar User Fee Act (“BsUFA”) was originally enacted in 2012, and the current legislative authority is set to expire at the end of September 2017. Under BsUFA, the U.S. Food and Drug Administration (“FDA”) is authorized to collect fees directly from biosimilar drug product applicants, and the fees are dedicated to expediting the approval
Introduction
The Biologics Price Competition and Innovation Act (“BPCIA”) created an abbreviated approval pathway for biological products shown to be “highly similar” to already FDA-approved biological products. By permitting the sponsor of a biological product to rely on data submitted by the holder of an FDA-approved biological product, the BPCIA is somewhat similar in concept
On January 12, 2017, FDA released its long-awaited final guidance on naming of biologics and biosimilars, entitled “Nonproprietary Naming of Biological Products.” According to FDA, the nonproprietary naming convention provided in the final guidance is intended to aid pharmacovigilance and to help prevent confusion and inadvertent substitution.
FDA’s newly-issued guidance covers the nonproprietary naming convention