Stelara® | Ustekinumab | Johnson & Johnson

03 Sep 2020 | All | Bio-Thera Solutions | Bio-Thera Solutions commences dosing in Ph I clinical trials of BAT2206 (proposed ustekinumab biosimilar).


30 Jul 2020 | US | Janssen | Janssen announces the FDA approved an additional indication for Stelara® (ustekinumab) for paediatric patients with skin lesions or moderate to severe plaque psoriasis.


26 Jun 2020 | All | Janssen | Janssen announces it has discontinued its Ph III LOTUS study of Stelara® (ustekinumab) in Systematic Lupus Erythematosus due to lack of efficacy.


15 May 2020 | All | Formycon | Formycon releases an update on its biosimilar portfolio.  Ph III clinical trials for a proposed ustekinumab biosimilar are scheduled to commence in Q3 2020. 


08 Apr 2020 | All | NeuClone | NeuClone Pharma announces it has completed monitoring visits and blood sampling for Ph I trials of NeuLara.


26 Mar 2020 | JP | Janssen | Janssen announces approval of additional indication of ulcerative colitis for Stelara® (ustekinumab) in Japan.


13 Mar 2020 | CN | Johnson & Johnson | J&J announces Dano® is now also indicated for the treatment of adults with moderate to severe Crohn's Disease. 


27 Jan 2020 | CA | Janssen | Health Canada approves ulcerative colitis as an additional indication for Stelara®.


22 Jan 2020 | UK | Janssen | The UK's NICE announces it will not recommend Stelara® for moderately to severely active ulcerative colitis due to uncertainties over cost-effectiveness.


18 Dec 2019 | All | NeuClone | NeuClone announces completion of patient recruitment and dosing in Ph I trials of ustekinumab biosimilar.


16 Dec 2019 | All | Dong-A Socio Holdings, Meiji Seika Pharma | Dong-A Socio Holdings and Meiji Seika announce commencement of Ph I trials of ustekinumab biosimilar.


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.


2019 | All | Polpharma Biologics | Polpharma publishes ustekinumab biosimilar is under development.


2019 | All | JHL Biotech | JHL Biotech publishes ustekinumab biosimilar is under development.


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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Biosimilars Bulletin 

August 19, 2020

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