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On 11 September 2026, Celltrion’s Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), was approved in Australia in a 300 mg/2 mL solution for injection in pre-filled pen (PFP) and pre-filled syringe (PFS) forms.

The Australian approval follows launch of...

On 11 September 2026, Shanghai Henlius Biotech announced that China’s National Medical Products Administration (NMPA) has accepted for review the new drug application (NDA) for HLX14 (120 mg/1.7 mL per vial), biosimilar to Amgen’s Xgeva® (denosumab).  This follows NMPA acce...

On 8 September 2026, Sandoz announced that it is aiming to establish a portfolio of more than 100 biosimilars by 2040 as part of its Bio100 plan to maximise value in the “golden decade” for biosimilars.  According to Sandoz, over the next 10 years, medicines worth more than...

On 8 September 2026, Biocon announced that, in partnership with Brazilian state-owned pharmaceutical laboratory, Bahiafarma, and Brazilian biotechnology company, Bionovis, it has entered a 10-year contract to supply Bmab 1500, biosimilar to Roche/Genentech’s Perjeta® (pertu...

On 4 September 2026, Business Standard reported that the Subject Expert Committee of India’s Central Drugs Standard Control Organisation (CDSCO) has given Roche a Phase 3 trial waiver for a high dose (920 mg) of Ocrevus® (ocrelizumab).  The waiver is conditional on Roche co...

On 4 September 2026, Daily Pharm Korea reported that South Korean-based Shin Poong Pharm has received Korean regulatory approval for Denovon™, biosimilar to Amgen’s Prolia® (denosumab).  The biosimilar is anticipated to launch at the end of 2026 following reimbursemen...