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GSK’s Nucala® (mepolizumab) has received approval in China and the UK as an add-on maintenance treatment for adult patients with inadequately controlled COPD characterised by raised blood eosinophils.

The approval by China’s National Medical Products Administration (...

On 6 January 2026, Fresenius Kabi announced that it has introduced a new presentation of Otulfi®, biosimilar to Janssen’s/J&J’s Stelara® (ustekinumab), in a 45 mg/0.5 mL single-dose vial for subcutaneous injection.

Following the introduction of this new presentat...

On 6 January 2026, Biocon Biologics announced that it will unveil three new biosimilars at the 2026 J.P. Morgan Healthcare Conference to be held 12-16 January 2026 in San Francisco.  The as yet unnamed biosimilars are for pembrolizumab (referencing MSD’s Keytruda®), nivolum...

Pearce IP’s Head of Litigation (NZ), Paul Johns, explores the usefulness of Swiss-type claims in New Zealand patents, including comparisons of key points of law and practice in other countries. He discusses the particular requirements for Swiss claims under New Zealan...

On 2 January 2026, Samsung Bioepis announced that it has begun direct commercialisation of Byooviz®, biosimilar to Genentech’s Lucentis® (ranibizumab), in Europe, following the transfer back of commercial rights from Biogen to Samsung Bioepis.

The pre-filled syringe ...

On 1 January 2026, Medical Dialogues reported that Dr Reddy’s has disclosed to various stock exchanges that it has received a Complete Response Letter (CRL) from the FDA in relation to its Biologics Licence Application (BLA) for AVT03, biosimilar to Amgen’s Prolia® and Xgev...

On 31 December 2025, Outlook Therapeutics announced that the FDA issued a Complete Response Letter (CRL) regarding the second resubmission of its Biologics Licence Application (BLA) for its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™, for wet AMD.

The C...

On 31 December 2025, Mabwell announced that it has received marketing approval from the Indonesian Food and Drug Authority for its Adalimumab Injection 9MW0113, biosimilar to AbbVie’s Humira®.

Mabwell jointly developed the biosimilar with Shanghai Junshi Biosciences ...