Read our latest updates & insights

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 ...

On 27 December 2025, Medical Dialogues reported that Aurobindo Pharma’s wholly-owned subsidiary, CuraTeQ, had terminated its agreement with US-based BioFactura Inc regarding BFI-751, biosimilar to Janssen’s/J&J’s Stelara® (ustekinumab).  The termination is said to have ...

On 25 December 2025, Innovent announced that its Tabosun® (ipilimumab N01 injection), referencing BMS’ Yervoy®, in combination with Tyvyt® (sintilimab, co-developed by Innovent and Eli Lilly), has been approved by China’s National Medical Products Administration as a neoadj...

On 22 December 2025, Amneal Pharmaceuticals and mAbxience announced that the FDA has approved Boncresa™ and Oziltus™ (MB09), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively.  The approval follows the FDA’s March 2025 acceptance for review of Amneal/mAbxie...

On 24 December 2025, Celltrion announced that it has secured approval in Korea for an autoinjector presentation (75mg and 150 mg) of Omlyclo®, biosimilar to Novartis’ Xolair® (omalizumab).

Omlyclo® (CT-P39) was the first omalizumab biosimilar approved in Korea in Jun...

On 23 December 2025,  Samsung Bioepis announced that it has received marketing approval in Japan for Nipro™, biosimilar to J&J’s/Janssen’s Stelara® (ustekinumab).  Nipro™ delivers ustekinumab in a subcutaneous 45mg injection, and is the first product to gain marketing a...

On 23 December 2025, Formycon and Bioeq (a joint venture between Formycon and Polpharma Biologics) jointly announced that the FDA approved Nufymco® as an interchangeable biosimilar to Genentech’s Lucentis® (ranibizumab).

Nufymco® is the third interchangeable ranibizu...