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On 2 April 2026, MSD announced that the European Commission has approved Keytruda® (pembrolizumab) in combination with paclitaxel, with or without bevacizumab, for the treatment of platinum resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in adu...

On 2 April 2026, The Economic Times reported that Bayer has reduced the upfront cost of Eylea® (aflibercept, 2mg) in India by about 44% to expand the eligible patient pool.  According to the report, Eylea® will now be priced at Rs 29,998, down from Rs 53,141.

The ann...

On 2 April 2026, Regeneron announced that the FDA has approved an extended dosing interval for Eylea HD® (aflibercept 8mg, “high dose”) of up to every 20 weeks for patients with nAMD and diabetic macular oedema (DME), following one year of successful response based on visua...

On 31 March 2026, Xbrane provided an update on the resubmission of its ranibizumab biosimilar BLA to the FDA following a Complete Response Letter (CRL) received in October 2025.  In November 2025, Xbrane had indicated that it expected to resubmit its BLA in March 2026.  How...

Shanghai Henlius and Organon have settled US BPCIA litigation brought by Amgen in June 2025 in relation to their denosumab biosimilars, Bilprevda® and Bildyos® (HLX14), as recorded by a Consent Order and Judgment filed with the US District Court for the District of New Jers...

In a LinkedIn post on 30 March 2026, Gedeon Richter announced that it expects its ustekinumab biosimilar “to become progressively available across European markets starting from March 2026”.

Gedeon Richter is commercialising the ustekinumab biosimilar in Europe under...

On 30 March 2026, Celltrion announced that it launched its high dose (300 mg) Omlyclo® (omalizumab), biosimilar to Genentech/Novartis’ Xolair®, in Korea, as reported by Korea Biomedical Review.

The Korean launch follows the January 2026 Canadian approval of high dose...

On 30 March 2026, Teva Pharmaceutical Industries announced that the FDA has approved Ponlimsi™, biosimilar to Amgen’s Prolia® (denosumab).  At the same time, Teva also announced that its regulatory applications for a biosimilar to Genentech/Novartis’ Xolair® (omalizumab) ha...

At its March 2026 meeting, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted the EMA’s April 2025 “Reflection paper on a tailored clinical approach in biosimilar development”.  Stakeholders had been invited to provide comm...