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On 10 April 2026, Replimune announced that the FDA had issued a complete response letter (CRL) to its BLA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.  Sushil Patel, Ph.D., CEO of Replimune said, “As we previously...

On 10 April 2026, Apotex announced that it received the first US FDA Tentative Approval for its Abbreviated New Drug Application (ANDA) for Semaglutide Injection, a generic version of Novo Nordisk’s Ozempic®.  FDA Tentative Approval signifies that Apotex’s product meets all...

On 1 April 2026, Shanghai Henlius Biotech announced that its Investigational New Drug (IND) application for HLX319, biosimilar to Genentech/Roche’s Phesgo® (Perjeta® (pertuzumab), Herceptin® (trastuzumab) and hyaluronidase), has been approved by China’s National Medical Pro...

On 9 April 2026, Biocon’s Yesintek®, biosimilar to Janssen’s Stelara® (ustekinumab), was approved in Australia in the following forms:

45 mg/0.5 mL solution for injection vial;
90 mg/1 mL solution for injection pre-filled syringe;
45 mg/0.5 mL solut...

On 9 April 2026, Shanghai Henlius Biotech announced that China’s National Medical Products Administration (NMPA) has approved two new non-Hodgkin’s lymphoma indications for Hanlikang® (HLX01), biosimilar to Genentech/Biogen’s Rituxan®/MabThera® (rituximab).

The two n...

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 ...