On Dec 24, 2024, Bio-Thera Solutions Inc. announced that it has partnered with Tabuk Pharmaceutical Manufacturing Company to commercialize BAT2206, a proposed ustekinumab biosimilar to Jansen’s STELARA, in Saudi Arabia. According to the partnership agreement, Tabuk will hold the marketing authorization and be responsible to manufacture, register, import, and market…
On December 18, 2024, Celltrion announced that the FDA has approved its ustekinumab biosimilar, STEQEYMA (ustekinumab-stba), referencing Jannsen’s STELARA. STEQEYMA is approved for subcutaneous injection or intravenous infusion in adult and pediatric patients for treatment of various psoriatic conditions, Crohn’s disease, and ulcerative colitis. STEQEYMA is the seventh ustekinumab biosimilar…
The European Medicines Agency’s (EMA) Committee for Medicinal Use Products (CHMP) recently recommended approval of six new biosimilars. The CHMP recommended approval of four biosimilars developed by Celltrion: (1) AVTOZVMA (tocilizumab), for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, CAR-T cell-induced…
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…
As we previously reported, this August the European Commission granted approval for Celltrion’s STELARA biosimilar, STEQEYMA. Earlier this month, Celltrion launched STEQEYMA in both Germany and the Netherlands. Celltrion also plans to launch STEQEYMA in Finland in mid-November, and in Ireland later in the month. STEQEYMA is the third ustekinumab…
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 October 9, 2024, Bio-Thera Solutions and Gedeon Richter announced they have reached an exclusive commercialization and license agreement for BAT2206, a biosimilar candidate to STELARA (ustekinumab). Under the agreement, Bio-Thera will be responsible for development, manufacturing, and supply of BAT2206, and Richter will have exclusive rights to commercialize the…
On October 14, 2024, Accord BioPharma, Inc. announced that the FDA has approved IMULDOSA (ustekinumab-srlf), a biosimilar to Johnson & Johnson’s STELARA (ustekinumab), indicated for the treatment of chronic inflammatory conditions, including psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. IMULDOSA is Accord BioPharma’s second FDA-approved biosimilar product in the…
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,…
As we have previously reported, the Inflation Reduction Act (IRA) changed the government’s treatment of certain prescription drugs under the Medicare program by directing the Secretary of Health and Human Services (HHS) to establish the Drug Price Negotiation Program (“the Program”; see here for a full recap of the Program’s…