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On 4 September 2025, Brazil’s National Health Surveillance Agency (Anvisa) announced that it seized a batch of a drug sold under the name Opdivo®, after medicine registration owner Bristrol-Myers Squibb notified Anvisa that the batch was not known to be genuine.

Coun...

On 2 September 2025, Polpharma Biologics S.A. and MS Pharma announced that they have entered into licensing agreements for the commercialisation of proposed biosimilar candidates to guselkumab (PB019, referencing Janssen’s Tremfya®), ocrelizumab (PB018, referencing Roche’s ...

On 2 September 2025, Shanghai Henlius and Organon announced that the FDA has approved Bildyos® and Bilprevda® (HLX14), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively, for all reference indications.

Shanghai Henlius/Organon’s denosumab biosimilars ...

On 1 September 2025, STADA announced that international private equity investment firm, CapVest Partners LLP, has signed a definitive agreement to acquire the majority stake in the company.  The transaction is expected to close in H1 2026, subject to regulatory approvals an...

On 1 September 2025, Searl announced that it has gained approval from Pakistan’s Drug Regulatory Authority to market and sell its denosumab biosimilars, referencing Amgen’s Prolia® and Xgeva®.

In July 2023, Searle entered into a licence agreement with China’s Mabwell...

On 1 September 2025, Korea Biomedical Review reported that the European Medicines Agency (EMA) has approved Celltrion’s Phase 3 clinical trial plan (IND) for CT-P44, biosimilar to Johnson & Johnson’s Darzalex® (daratumumab), in relapsed or refractory multiple myeloma.  ...

On 1 September 2025, Australia’s Pharmaceutical Benefits Scheme published its summary of changes for the month of September.  Among the changes was the PBS-listing of Amgen’s supplemental denosumab brands, Corora® (60mg/ml PFS) and Ganvado® (70mg/ml vial), referencing Proli...

On 1 September 2025, Medical Dialogues reported that Lupin received approval from India’s Central Drugs Standard Control Organisation (CDSCO) to conduct a Phase 1 study of its certolizumab pegol biosimilar in 200mg PFS presentation, referencing UCB’s Cimzia®.

In July...

On 28 August 2025, Celltrion announced that it has launched two biosimilars in Vietnam:

Remsima® SC, biosimilar to Janssen’s Remicade® (infliximab); and
Herzuma®, biosimilar to Roche/Genentech’s Herceptin® (trastuzumab).

Alongside this launch, Celltr...