Replies to post #222565 on Biotech Values

[DewDiligence]

PFE submits sBLA seeking interchangeability for Humira biosimilar, Abrilada, which was approved (without interchangeable status) by the FDA in 2019:

https://www.pfizer.com/news/press-release/press-release-detail/fda-accepts-review-pfizers-supplemental-application

The PAS [i.e. sBLA] was supported by positive topline data from the REFLECTIONS B538-12 study which evaluated multiple switches between treatment with ABRILADA and its reference product, Humira, both of which were administered with methotrexate in adult patients with moderate to severe rheumatoid arthritis (RA). The study met its primary goal by demonstrating pharmacokinetic equivalence in patients who switched multiple times between treatment with the two medicines. The company anticipates submitting study results for presentation at an upcoming medical congress.

The BsUFA date is in 4Q22. In the US, the FDA has approved eight Humira biosimilars, but only the one from Boehringer-Ingelheim, which has not yet launched, currently has interchangeable status.

Pursuant to a legal settlement in 2018 (#msg-145185001), PFE can launch Abrilada in the US market in Jul 2023.

Note: PFE’s PR was issued on 2/25/22.