(Not that we had anything to do with Califf’s confirmation but we are all glad that this is in the Agency’s rearview mirror and it now has a permanent rudder for the foreseeable future.)

Anyway, the AAM annual meeting is in full swing and I thought that I would give a few bullet points of some of the factoids we learned today:

  • Good news for the future of the generic pharmaceutical industry as, in the next four years, there are 166 billion dollars of innovator products that will be eligible for generic competition.
  • The FDA issued 149 new and revised product-specific bioequivalence recommendations, with fifty‑four of them for complex generic products.
  • With the first biosimilar approved in 2015, there are now thirty‑three approved, twenty‑one of them being marketed today and the rest winding their way through the patent thicket. Also, there are two biosimilars approved as interchangeable.
  • There is lots of real‑world data on the use of biosimilar products; according to Cigna, there are 700 million “patient days” of data just for its patients alone.
  • A representative from Sandoz stated that we should not create additional barriers for the use of biosimilars and not get hung up on interchangeability since all biosimilars are approved for safety and efficacy.

Additional details of the generic program’s efforts can be found in the Office of Generic Drugs 2021 Annual Report (here).