Stelara® | Ustekinumab | Johnson & Johnson

09 Nov 20 | All | Formycon, Bioeq | Formycon and Bioeq announces they have commenced dosing in Ph III trials of FYB202 (proposed ustekinumab biosimilar) in patients with moderate to severe plaque psoriasis.

 

28 Oct 20 | All | Amgen | In its Q3 2020 financial results, Amgen announces that it is moving ABP 654 (proposed ustekinumab biosimilar) into Ph III development.

 

22 Oct 2020 | All | Formycon, Bioeq | Ph III clinical trials of FYB202 (proposed ustekinumab biosimilar developed by Formycon and Bioeq) commence recruiting in Poland.

 

20 Oct 2020 | All | NeuClone | NeuClone announces its proposed ustekinumab biosimilar has successfully met all primary and secondary endpoints in Ph I clinical trials. Noelle Sundstrom, CEO of NeuClone announced that the company plans to enter Ph III trials in 2021. The product is being jointly developed by NeuClone and the Serum Institute of India.

 

10 Sep 2020 | All | All | A new study presented at the Congress of Clinical Rheumatology East indicates that ustekinumab is safe and efficacious in young and elderly patients with psoriatic arthritis. Researchers reported that there were no clinically meaningful differences in the effectiveness and safety in PsA patients 60 years or older compared with those younger than 60.

 

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 

November 9, 2020

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