Read our latest updates & insights

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...

On 23 December 2025, CSPC Pharmaceutical Group Limited announced that it has obtained approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China of its Daratumumab Injection, biosimilar to Johnson & Johnson’s Darzalex®.

On 23 December 2025, Biocon Biologics announced that is has secured full and exclusive global rights for Hulio®, biosimilar to AbbVie’s Humira® (adalimumab), from Fujifilm Kyowa Kirin Biologics Co., Ltd. (FKB).

Under the new agreement, which supersedes an existing co...

On 22 December 2025, Alvotech announced the European launch of Gobivaz® (AVT05), biosimilar to Janssen’s Simponi® (golimumab), which is the first golimumab biosimilar to be marketed worldwide.

Gobivaz® has been awarded a National Health Service (NHS) England te...