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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

Australia’s Neuclone discloses the 5th product in its pipeline is biosimilar denosumab, which is at the pre-clinical stage.

Glenmark announces the launch of biosimilar adalimumab (developed by Zydus, marketed as Adaly®), in India.