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Stelara® | Ustekinumab | Johnson & Johnson

December 4, 2019

04 Dec 2019 | CN | Bio-Thera Solutions | Bio-Thera announces NMPA approval to commence Ph I trials of ustekinumab biosimilar.


28 Oct 2019 | All | Formycon | Formycon announces dosing has begun in PhI clinical trials of ustekinumab biosimilar.


17 Oct 2019 | All | NeuClone | Neuclone announces it has commenced dosing in Phase I clinical trials of biosimilar ustekinumab candidate. 


08 Sep 2019 | EU | Janssen | Janssen announces EC approval for additional indication for Stelara®. Stelara® is now indicated for the treatment of ulcerative colitis.


15 May 2019 | All | Neuclone/Serum Institute | Neuclone confirms Ph1 trials of biosimilar ustekinumab will commence in the second half of 2019, as previously announced.


09 Apr 2019 | JA | Alvotech, Fuji Pharma | Alvotech and Fuji Pharma announce exclusive agreement for the commercialisation of Stelara® biosimilar in Japan. Alvotech will be responsible for development and supply while Fuji Pharma will receive exclusive rights to commercialise the drug in Japan. This follows Fuji Pharma's recent US $50 million investment in Alvotech.


10 May 2018 | All | Neuclone/Serum Institute | Australia's Neuclone announces preclinical results for its biosimilar ustekinumab, which are now scheduled for Ph 1 clinical trials in 2019.


08 Jan 2018 | All | Neuclone | Australia's Neuclone confirms ongoing development of biosimilar ustekinumab, which is on target to enter Ph I trials in 2018.  Read more


11 May 2017 |All| Formycon| Germany's Formycon is developing biosimilar ustekinumab, targeting 2023 for a US launch, and 2024 for EU launch.  Read more







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