On November 29, 2022, Janssen filed a BPCIA complaint in the District of Delaware against Amgen related to Amgen’s ustekinumb biosimilar ABP 654 of Janssen’s STELARA. This is Janssen’s first BPCIA case filed with...more
On November 11, 2022, STADA Arzneimittel AG (“STADA”) and Xbrane Biopharma AB (“Xbrane”) announced that the European Commission has granted a marketing authorization for XIMLUCI (ranibizumab), a biosimilar to Genentech’s...more
On November 7, the U.S. Patent and Trademark Office (USPTO) published a request for comments on areas for USPTO-FDA collaboration and engagement. The USPTO also announced a related public listening session to be held...more
11/9/2022
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This week Formycon AG (“Formycon”) announced details of its previously undisclosed pipeline project for FYB206, Formycon’s biosimilar of KEYTRUDA (pembrolizumab). KEYTRUDA is approved for the treatment of advanced...more
On September 19, 2022, the European Medicines Agency’s (“EMA”) Biosimilar Medicines Working Party (“BMWP”) and the Heads of Medicines Agencies (“HMA”), a network of the heads of the authorities responsible for the...more
This week Formycon AG (“Formycon”) announced positive preliminary efficacy and safety data from the VESPUCCI Phase III clinical trial for FYB202, Formycon’s biosimilar version of STELARA (ustekinumab). The Phase III...more
The Big Molecule Watch is monitoring clinical trial activities involving adalimumab. Here we report on three recent studies with adalimumab biosimilars for treating psoriasis, inflammatory bowel disease, Crohn’s...more