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Regeneron and Bayer have withdrawn a preliminary injunction (PI) application against Sandoz in Germany in relation to Sandoz’s Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg).  According to a JUVE Patent report of 27 March 2026, the result is that Sandoz ...

On 25 March 2026, the Australian Pharmaceutical Benefits Assessment Committee (PBAC) published the agenda for its July 2026 meeting, with three biosimilars submitted for consideration.

One of the biosimilars will be considered for the first time, Biocon’s Yesintek®, ...

On 24 March 2026, Regeneron and Sanofi announced that the Japanese Ministry of Health, Labour and Welfare has approved Dupixent® (dupilumab) for the treatment of adults with moderate-to-severe bullous pemphigoid (BP).  Dupixent® is also approved in Japan for certain patient...

On 24 March 2026, Shanghai Henlius Biotech announced that Health Canada has approved Bildyos® and Tuzemty® (HLX14), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively, across all reference indications.

Under a June 2022 agreement, Organon has exclusiv...

On 24 March 2026, Singapore-headquartered Prestige Biopharma announced that it is “accelerating commercialisation” of Vasforda®/HD204, biosimilar to Genentech’s Avastin® (bevacizumab), following positive results from its global Phase 3 clinical trial.  The trial was conduct...

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...