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On 16 September 2026, Fuji Pharma announced that it has obtained marketing approval in Japan for Golimumab BS 50 mg autoinjector for subcutaneous injection (AVT05), biosimilar to Janssen’s Simponi® (golimumab), and Ustekinumab BS 130 mg intravenous infusion (AVT04), biosimi...

On 15 September 2026, The Economic Times reported that Dr Reddy’s has launched Nivorz™, biosimilar to BMS’ Opdivo® (nivolumab), in India.  Nivorz™ will be available in single-dose vial presentations (40 mg, 100 mg and 240 mg) and will be manufactured at Dr Reddy’s bio...

During a presentation on 15 September 2026, Amgen confirmed that it has filed an abbreviated Biologics License Application (aBLA) with the FDA for a biosimilar to Bristol Myers Squibb/Ono Pharmaceutical’s Opdivo® (nivolumab).  The aBLA has been accepted for review.  This is...

On 15 September 2026, Celltrion announced that it has filed an Investigational New Drug (IND) application with the FDA for a Phase 4 clinical trial of high-dose (240 mg) Zymfentra™ (SC infliximab), biosimilar to Janssen’s Remicade® (IV infliximab).

The trial aims to ...

In a judgment published on 15 September 2026 (but delivered on 27 August 2026), the Federal Court of Australia found that Pfizer had failed to establish that Samsung Bioepis’ production of Brenzys®, biosimilar to Pfizer’s Enbrel® (etanercept), infringed Pfizer’s Australian ...

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...