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On 7 April 2026, Apotex announced that Health Canada has approved Denoza™, biosimilar to Amgen’s Prolia® (denosumab), for all indications of the reference biologic.

Sandoz’s Wyost® (approved February 2024) and Jubbonti® (approved March 2024) were the first denosumab ...

On 7 April 2026, Biocon Limited announced that it has launched Bosaya™ and Aukelso™ (denosumab-kyqq), biosimilars to Amgen’s Prolia® and Xgeva®, respectively, in the US.  The launch follows Biocon’s 1 October 2025 settlement and licence agreement with Amgen, which permitted...

On 7 April 2026, Outlook Therapeutics announced that it has submitted a formal dispute resolution request (FDRR) to the FDA following a Type A meeting in March 2026 in relation to its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™, for wet AMD.

The FDRR is...

On 6 April 2026, Aurobindo’s wholly owned subsidiary, CuraTeQ Biologics, announced it has obtained positive top-line results from a Phase 3 study of BP11 (omalizumab, 300 mg), biosimilar to Genentech/Novartis’ Xolair®.

According to CuraTeQ, the study, which was condu...

On 2 April 2026, Biocon filed a petition for post grant review (PGR) of Regeneron’s patent US12168036 entitled “Methods for Treating Angiogenic Eye Disorders with High Doses of VEGF Receptor Fusion Proteins”.

Biocon’s petition seeks to join Alvotech’s pending PGR in ...

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...