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On 20 March 2026, Novo Nordisk announced that the FDA has approved its 7.2mg semaglutide injection, Wegovy® HD, for the reduction of excess body weight and maintenance of weight reduction long-term.  The high dose formulation is expected to be launched in the US in a single...

On 20 March 2026, Celltrion announced that it has obtained additional approval from Health Canada for an autoinjector formulation of Steqeyma®, biosimilar to Janssen’s Stelara® (ustekinumab).  This approval enables Celltrion to launch two additional autoinjector formulation...

On 20 March 2026, BMS announced that Opdivo® (nivolumab) has received approvals from the FDA, in combination with doxorubicin, vinblastine and dacarbazine (AVD) for the treatment of previously untreated, Stage III or IV classical Hodgkin Lymphoma (cHL) and from the European...

On 20 March 2026, Accord BioPharma, Intas Pharmaceuticals and Bio-Thera Solutions together filed four petitions for Inter Partes Review of Janssen’s US patent numbers 12,291,566 (IPR2026-00259), 12,122,824 (IPR2026-00258), 11,041,020 (IPR2026-00257) and 11,014, 982 (IPR2026...

On 19 March 2026, Chugai Pharmaceutical (a Roche subsidiary) announced that it filed a regulatory application with Japan’s Ministry of Health, Labour and Welfare for the medical device component of its Port Delivery Platform with ranibizumab.

The Port Delivery Platfo...

During its Q4/2025 Earnings Call on 19 March 2026, Alvotech provided updates on its launch plans and regulatory applications for various biosimilars, including golimumab, aflibercept, vedolizumab and pembrolizumab.

Alvotech confirmed that Gobivaz® (AVT05) was launche...

On 19 March 2026, Formycon and Klinge announced they have entered into a settlement and licence agreement with Regeneron/Bayer for FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), 2mg, in Europe and key markets in the Latin American and Asia-Pacific regions.  T...

On 18 March 2026, Sandoz announced it has entered into a licence, development and commercialisation agreement with Samsung Bioepis for up to five biosimilars, including vedolizumab.

Under the agreement, Sandoz will have exclusive rights to commercialise the biosimila...