BioBlast®

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).

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.

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 (proposed ustekinumab biosimilar developed by Formycon and Bioeq) commence recruiting in Poland.

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.

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 dosing in Ph I clinical trials of BAT2206 (proposed ustekinumab biosimilar).

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

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

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

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

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

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

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 ustekinumab biosimilar.

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 ustekinumab biosimilar.

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

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