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On 23 March 2026, Bayer announced that Japan’s Ministry of Health, Labour and Welfare has approved Eylea™ 8 mg (aflibercept 8mg) for the treatment of macular oedema following retinal vein occlusion (RVO).  RVO is the third indication for Eylea™ 8mg in Japan, in addition to ...

On 23 March 2026, Cytiva announced that it has entered a contract with Yoshindo to support Yoshindo’s plans to establish biosimilar manufacturing capabilities for the Japanese market.  Yoshindo expects to begin supplying biosimilars manufactured in its own plant in Toyama f...

On 23 March 2026, Mochida Pharmaceutical and Ayumi Pharmaceutical announced that RGB-19, biosimilar to Roche’s RoActemra® (tocilizumab) was approved in Japan.  The approval covers forms of the biosimilar for intravenous infusion, subcutaneous injection and in an autoinjecto...

On 23 March 2026, Bio-Thera Solutions announced that it has entered an exclusive agreement with Intas Pharmaceuticals for the Indian commercialisation of BAT2506 (golimumab), biosimilar to J&J’s Simponi®.  According to Bio-Thera, this represents its first biosimilar par...

On 21 March 2026, multiple generic semaglutide products launched on the Indian market, proclaiming “Day 1 entry” on expiry of Novo Nordisk’s core Indian patent for semaglutide (Ozempic®/Wegovy®).

The products launched on the Indian market include:

Dr Reddy’s...

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...