Biosimilars & Generics

David Gaugh, AAM’s executive VP of sciences and regulatory affairs, was named the interim CEO, making him the fourth person to run the association since February 2020.

Sen. Mike Lee, R-UT, has introduced draft legislation in the US that would stop the FDA from requiring biosimilars to conduct ‘unnecessary’ switching studies in order to obtain an interchangeability designation.

ANVISA, Brazil’s medicines regulator, is asking for feedback on the regulatory pathway for biosimilars.

Jazz’s REMS patent on distribution of Xyrem does not belong in the Orange Book because it is directed to systems rather than a method of using the drug, court rules, agreeing with FTC’s analysis.

ASP metric used in Medicare, and often in commercial insurance, for reimbursement of physician-administered drugs is an important factor in the sales arc for biosimilars. Price negotiations under IRA could bring their own margin-squeezing pain to pharmacy-benefit biosimilars.

US FDA has 120 days to review generic sponsors’ requests for letters to help them obtain product samples, but will not send them to the reference product company.

The European Medicines Agency said it was possible to use immunobridging studies to authorize COVID-19 vaccines now that a number of COVID-19 vaccines authorized in the EU are proven to be safe and effective and can be used as comparators in trials.

The Union for International Cancer Control and the World Health Organization are prioritizing off-patent drugs in their efforts to facilitate oncology medicine access in developing nations.

Agencies are holding public ‘listening session’ to get input on method of use patents and ‘skinny labeling,’ REMS patenting, PTAB proceedings and other topics.

Acting OGD Director Susan Rosencrance says in an interview that the generics assessment system has evolved substantially since she moved to the Office of Pharmaceutical Quality in 2015.

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Spanish competition regulator the CNMC has fined Merck Sharp and Dohme €39m for abusing its dominant position, by blocking Insud Pharma’s rival to the Nuvaring vaginal contraceptive ring through “unjustified legal action” that sought to delay market entry of Insud’s Ornibel version. The originator is considering an appeal.