Read our latest updates & insights

Alvotech announced that the FDA has granted a new Biosimilar User Fee Amendment goal date of 13 April 2023 for its AVT02 (biosimilar adalimumab), and that FDA has confirmed that the data provided are sufficient to support a determination of interchangeability, subject to a ...

Celltrion announced that it has submitted a BLA for CT-P13 SC (subcutaneous biosimilar infliximab) with the FDA.  CT-P13 is the first and only known infliximab to have both intravenous and subcutaneous formulations.

Ontario announced that it will adopt a biosimilars switching program from 31 March 2023.  Patients currently treated with Copaxone® (glatiramer acetate), Enbrel® (etanercept), Humalog® (insulin lispro), Humira® (adalimumab), Lantus® (insulin glargine), NovoRapid® (insulin a...

Significant biosimilar activities this week include:

15 Dec 22 | Zhejiang Doer Biologics and Merck clinical trials

Zhejiang Doer Biologics announced a clinical trial collaboration agreement with Merck to evaluate DR30303 (humanized anti-Claudin18.2 heavy chain...

Dr Reddy’s announced that DRL_TC (biosimilar tocilizumab) met is primary and secondary endpoints in Ph I trials.  Dr Reddy’s is developing DRL_TC in both subcutaneous and intravenous formulations.

Regeneron and Sanofi announced that the EC has expanded  the marketing authorisation for Dupixent® (dupilumab) in the EU to include adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.  Dupixent is the only targeted medicine to treat pru...

Zhejiang Doer Biologics announced a clinical trial collaboration agreement with MSD to evaluate DR30303 (humanized anti-Claudin18.2 heavy chain antibody Fc fusion protein) in combination with Keytruda® (pembrolizumab).  Under the agreement, Doer Bio will conduct the clinica...

MSD and Moderna announced that the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial of mRNA-4157/V940 (investigational personalized mRNA cancer vaccine), in combination with Keytruda® (pembrolizumab), demonstrated a statistically significant and clinically meaningful improvement i...

Fresenius Kabi announced that the FDA has approved its citrate-free biosimilar adalimumab (Idacio®) for all Humira® indications.  Idacio was approved in the EU 2019.  Fresenius intends to launch in the US in July 2023 pursuant to its settlement agreement with AbbVie.