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Chong Kun Dang announces approval for biosimilar darbepoetin from the Ministry of Food and Drug Safety of South Korea. This is the first biosimilar darbepoetin to be approved in a highly regulated country.

Shanghai Henlius’ research team presented an update on its TmAb clinical program with Phase III trials underway in Poland, Ukraine, Phillippines and China.

Prestige announces licensing agreement with Cipla, granting Cipla exclusive rights to distribute and market Prestige’s TmAb biosimilar in emerging markets.

Fuji Pharma announces acquisition of 4.2% stake in Alvotech for roughly $50 million.

The NHS announces negotiations for the supply of adalimumab biosimilars have concluded with Amgen, Biogen, Mylan, Sandoz and AbbVie. This deal is predicted to save the NHS £300M per year.

Biocon announces EU marketing authorisation for biosimilar trastuzumub, Ogivri®. Ogivri® is indicated for the treatment of HER2 positive early breast cancer, metastatic breast cancer and metastic gastric cancer.

FDA approves TmAb biosimilar for the treatment of HER2-positive breast cancer. Herzuma® is the second TmAb biosimilar to be approved in the US. Celltrion is currently defending the biosimilar against Genentech, and while Genentech and Pfizer have reached a settlement, Cellt...

Xbrane submits first CTA to FDA for clinical trials of ranibizumab biosimilar candidate, Xlucane®. The Phase III trials will be conducted in patients with wet form of age-related macular degeneration.

Amgen files BLA for biosimilar infliximab.

NeuClone announces that it has biosimilar pertuzumab in preclinical development.