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On 26 August 2026, Biocon announced that it received marketing authorisation from Japan’s Ministry of Health, Labour and Welfare for its pegfilgrastim biosimilar, referencing Amgen’s Neulasta® (known as G-Lasta® in Japan).  The biosimilar will be exclusively marketed in Jap...

On 26 August 2026, the Economic Times reported that India’s CDSCO has approved Dr Reddy’s biosimilar to BMS’ Orencia® (abatacept) for the treatment of moderate to severely active rheumatoid arthritis and active psoriatic arthritis in patients who have responded inadequately...

On 25 August 2026, Celltrion announced that it has launched Omlyclo® 300 mg, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), in Europe, commencing in Germany, the UK and France.

Omlyclo® was the first (and remains the only) omalizumab biosimilar to be approve...

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...