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Sandoz obtains Sandoz Australian approval for biosimilar adalimumab Hyrimoz®. This is the third biosimilar adalimumab approval in Australia.

Celltrion gains Australian approval for biosimilar rituximab under two product names, Rituzena® and Tuxella®.

Apotex division Apobiologix launches pegfilgrastim biosimilar, Lapelga® in Canada.

FDA approves subcutaneous formulation of Herceptin for the treatment of HER2-overexpressing breast cancer.

In ongoing litigation between Boehringer and AbbVie, the court has ordered Boehringer to release its plans for biosimilar adalimumab, Cytelzo®. Cytelzo® has been approved by the FDA but has not yet been launched.

Selexis SA announces it has executed two commercial licence agreements with Turgut Pharmaceuticals for the development of biosimilar antibodies. This expansion of the partnership between the two companies aims to develop a biosimilar for the treatment of metastatic HER2-pos...

Samsung Bioepis partners with C-Bridge to commercialise biosimilars in China. Under the deal, C-Bridge will develop a new company, AffaMed Therapeutics to launch candidates such as ranibizumab, eculizumab and trastuzumab biosimilars.

Sandoz files suit against Amgen, seeking DJ of non-infringement and invalidity. This comes as Sandoz awaits FDA decision on its pegfilgrastim biosimilar, with Sandoz hoping to block any preliminary injunction motions from Amgen.

China’s National Medical Products Administration approves first rituximab biosimilar, Hanlikon®.

Alteogen announces new drug application to the Ministry of Food and Drug Safety for aflibercept biosimilar, ALT-L9.