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Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast™ updates below.
Scientific Name: ustekinumab

Cipla expands biosimilar partnership with Alvotech for ANZ

March 2, 2021

Cipla and Alvotech announced that they have expanded their partnership for the marketing and distribution of four biosimilar medicines in Australia and New Zealand. The agreement includes biosimilar aflibercept, ustekinumab, denosumab and golimumab candidates. This agreement is in addition to the previous agreement between Alvotech and Cipla for the commercialisation of AVT02 (biosimilar adalimumab candidate).

Vizient releases Pharmacy Market Outlook

January 27, 2021
Health care performance improvement company Vizient releases its Winter 2021 Pharmacy Market Outlook. Vizient projected that the greatest price increases to members would occur in Humira® (adalimumab), with a 7.5% price increase predicted over the next 18 months. Adalimumab also topped the list of greatest total spend by product among Vizient members, followed by pembrolizumab, rituximab, infliximab, ustekinumab, nivolumab and denosumab. New figures also showed trastuzumab biosimilars have captured a significant market share, contributing to 39% of cost to members in September 2020.

Celltrion provides ustekinumab update

December 21, 2020
Celltrion announces Ph III trials of its proposed ustekinumab biosimilar CT-P43 will be completed by the second half of 2022. Celltrion also announced plans to launch the product when the API patents expire in the EU in September 2023 and in the US in July 2024.

Formycon and Bioeq commence Ph III trials of ustekinumab

November 9, 2020

Formycon and Bioeq announce they have commenced dosing in Ph III trials of FYB202 (proposed ustekinumab biosimilar) in patients with moderate to severe plaque psoriasis.

Amgen releases Q3 2020 financial results

October 28, 2020

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

Ph III clinical trials of FYB202 commence

October 20, 2020

Ph III clinical trials of FYB202 (proposed ustekinumab biosimilar developed by Formycon and Bioeq) commence recruiting in Poland.

NeuClone announces Ph I clinical trials ustekinumab biosimilar results

October 20, 2020

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.

Polpharma publishes ustekinumab biosimilar is under development

October 16, 2020

Polpharma publishes ustekinumab biosimilar is under development.

Congress of Clinical Rheumatology East presents results from new study on ustekinumab

September 10, 2020

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.

Bio-Thera Solutions commences clinical trials of BAT2206

September 3, 2020

Bio-Thera Solutions commences dosing in Ph I clinical trials of BAT2206 (proposed ustekinumab biosimilar).

FDA approves additional indication for Janssen Stelara®

July 30, 2020

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

Humira® sales negatively impacted by prescription of alternative mechanism of action agents

July 20, 2020

Spherix reports that the EU market for AbbVie’s Humira® has been negatively impacted by gastroenterologists increasingly prescribing alternative mechanism of action agents, including Stelara® (ustekinumab) and Entyvio® (vedolizumab) for ulcerative colitis (UC) and Crohn’s disease (CD) and the increased prescription of adalimumab biosimilars. These increases have come at a cost to AbbVie, with use of Humira® in UC and CD decreasing in the EU.

Janssen discontinues Ph III LOTUS study of Stelara®

June 26, 2020

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

Formycon update on biosimilar portfolio

May 15, 2020

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

NeuClone Pharma announces progress for Ph I trials of NeuLara

April 8, 2020

NeuClone Pharma announces it has completed monitoring visits and blood sampling for Ph I trials of NeuLara.

Janssen announces additional indication for Stelara® approved

March 26, 2020

Janssen announces approval of additional indication of ulcerative colitis for Stelara® (ustekinumab) in Japan.

J&J announces Dano® indication

March 14, 2020

J&J announces Dano® is now also indicated for the treatment of adults with moderate to severe Crohn’s Disease. 

Health Canada approves additional indication for Stelara®

January 27, 2020

Health Canada approves ulcerative colitis as an additional indication for Stelara®.

UK’s NICE discourages Stelara®

January 22, 2020

The UK’s NICE announces it will not recommend Stelara® for moderately to severely active ulcerative colitis due to uncertainties over cost-effectiveness.

NeuClone announces completion of patient recruitment and dosing in Ph I trials of biosimilar ustekinumab

December 18, 2019

NeuClone announces completion of patient recruitment and dosing in Ph I trials of ustekinumab biosimilar.

Dong-A Socio Holdings and Meiji Seika announce commencement of Ph I trials of biosimilar ustekinumab

December 16, 2019

Dong-A Socio Holdings and Meiji Seika announce commencement of Ph I trials of ustekinumab biosimilar.

Bio-Thera announces NMPA approval to commence Ph I trials of biosimilar ustekinumab

December 4, 2019

Bio-Thera announces NMPA approval to commence Ph I trials of ustekinumab biosimilar.

Formycon announced dosing has begun in Ph I trials of biosimilar ustekinumab

October 28, 2019

Formycon announces dosing has begun in PhI clinical trials of ustekinumab biosimilar.

NeuClone announces commenced dosing in Ph I trials of biosimilar ustekinumab

October 17, 2019

NeuClone announces it has commenced dosing in Phase I clinical trials of biosimilar ustekinumab candidate.