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FDA approves Xbrane’s Phase III clinical trial for a biosimilar ranibizumab candidate Xlucane®.  Xbrane expects to enrol approximately 600 patients in 16 countries with the first patient expected in March 2019.

Korean Biosimilar company Alteogen announces completion of pre-clinical studies relating to ALT-L9, biosimilar aflibercept, and that it intends to file an investigational NDA with the US in 2018.  It also intends to roll out aflibercept in Japan (through partner Kissei Phar...

Kissei announces positive Ph III trials for JR131, biosimilar darbepoetin, with a view toward regulatory filing in 2018.

Sandoz announced the FDA has accepted for review its application under s351(k) for biosimilar adalimumab.   

Genentech has sued Sandoz and Kyowa Hakko Kirin (Sandoz’s exclusive distributor) in Japan, alleging the sale of biosimilar RmAb (Rixathon®/Riximyo®) infringes 3 Genentech patents. Rixathon®/Riximyo® was approved in JP in Sep 2017.

At the JP Morgan conference, Richard Gonzalez, (chairman of the board and CEO of AbbVie) confirms that AbbVie does not expect biosimilar competition for Humira® until 2022.

Teva and Celltrion file DJ action in the District Court (Northern District of California) against 37 rituximab patents alleging they are invalid, unenforceable and/or not-infringed. FDA accepted Celltrion’s ABLA on 27 June 2017, and the parties entered a patent dance....

Biocad obtains approval for its biosimilar infliximab in Russia.

Amgen discloses at JP Morgan Healthcare Conference that it is in process development for a cetuximab biosimilar.

Australia’s NeuClone confirms ongoing development of biosimilar ustekinumab, which is on target to enter Ph I trials in 2018.  Read more