On December 1, 2024, Biocon announced that the FDA has approved YESINTEK™ (ustekinumab-kfce), a biosimilar to J&J’s STELARA®. YESINTEK is approved for the treatment of Crohn’s disease, Ulcerative Colitis, Plaque Psoriasis and Psoriatic Arthritis. According to the announcement, Biocon had entered into a settlement and licensing agreement with Janssen to…
Alvotech recently submitted a Citizen Petition to the FDA requesting that the agency refuse to license any ustekinumab biosimilar as interchangeable with STELARA if it is manufactured using a Chinese hamster ovary (“CHO”) cell line—and in particular Samsung Bioepis’s PYZCHIVA (ustekinumab-ttwe). Alvotech stated that “unless and until the Agency has…
On September 27, 2024, Formycon AG (“Formycon”) and its commercialization partner Fresenius Kabi (“Fresenius”) jointly announced that the European Commission (EC) has issued a marketing authorization for FYB202/OTULFI™ (ustekinumab-aauz), a biosimilar to STELARA®. FYB202/OTULFI™ is an interleukin-12 and interleukin-23 antibody and was approved for moderately to severely active Crohn’s disease,…
Samsung Bioepis’ PYZCHIVA On July 1, Samsung Bioepis Co., Ltd. announced that the FDA has approved PYZCHIVA (ustekinumab-ttwe), a biosimilar referencing STELARA (ustekinumab). PYZCHIVA is approved for the treatment of moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active…
On April 25, 2024, the Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion, recommending the granting of marketing authorization for Biogen Netherlands B.V.’s biosimilar TOFIDENCE (tocilizumab), for the treatment of rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA) and coronavirus disease…
On February 29, Biocon Biologics Ltd announced that it signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson (“J&J”) regarding Bmab 1200, Biocon’s proposed biosimilar to STELARA. The agreement allows Biocon to launch in the United States in February 2025, pending FDA approval. As part…
As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023. Below are some of the top regulatory developments from 2023. FDA Approvals In 2023, there were 23 FDA approvals of Biologic License Applications, including for Vertex’s CASGEVY and Bluebird’s LYFGENIA, the first…
On Tuesday, October 31, FDA approved Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to and interchangeable with Janssen’s STELARA (ustekinumab). WEZLANA is the first product to be approved as a biosimilar to STELARA. As we covered previously, Janssen and Amgen settled their BPCIA litigation regarding Amgen’s ustekinumab biosimilar product in May 2023….