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On 24 August 2026, Celltrion announced that it has applied to Korea’s Ministry of Food and Drug Safety for approval of CT-P51, biosimilar to MSD’s Keytruda® (pembrolizumab).  This is the second biosimilar pembrolizumab application filed in Korea, following Samsung Bioepis’ ...

On 21 August 2026, Celltrion announced that it has launched Steqeyma®, biosimilar to Janssen’s Stelara® (ustekinumab), in an intravenous (IV) formulation in Japan.

Celltrion’s IV formulation of Steqeyma® was approved in Japan in April 2026, with the subcutaneous form...

On 21 August 2026, Alvotech and Lotus Pharmaceutical announced that they have entered into a licensing and commercialisation agreement for Alvotech’s AVT34, biosimilar to AstraZeneca’s Imfinzi® (durvalumab), and AVT87, biosimilar to Roche/Genentech’s Hemli...

On 21 August 2026, the outcomes of the July 2026 meeting of the Australian Pharmaceutical Benefits Advisory Committee (PBAC) were published, with the following biosimilars recommended for PBS listing:

Biocon/Generic Health’s Yesintek® (ustekinumab), biosimilar to J...

On 19 August 2026, Ono announced that it has received additional approval for Opdivo® (nivolumab) Intravenous Infusion from the Taiwan Food and Drug Administration (TFDA), for the neoadjuvant treatment of adult patients with resectable Non-Small Cell Lung Cancer (NSCLC) and...

On 18 August 2026, Biocon announced that it has received supplemental FDA approval for Yesintek®, biosimilar to Janssen’s Stelara® (ustekinumab), in a single-dose prefilled autoinjector format (45 mg/0.5 ml and 90 mg/ml).

Biocon first launched Yesintek® in the US in ...

On 18 August 2026, Avalon Pharmaceutical and Bio-Thera Solutions announced that they have entered into an exclusive licensing agreement for the commercialisation of Bio-Thera’s BAT2406, biosimilar to Sanofi/Regeneron’s Dupixent® (dupilumab), in MENA.

Under the agreem...