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Significant biosimilar activities this week include:

09 Feb 23 | EU | EMA accepts MAA for Alvotech’s AVT04 (ustekinumab biosimilar)

Alvotech and STADA announced that EMA has accepted the MAA for Alvotech’s AVT04 biosimilar to Janssen’s Stelara™.  The companies...

A new Fresenius Kabi study published in the Expert Review of Clinical Immunity has confirmed pharmacokinetic bioequivalence between a tocilizumab biosimilar and a US-licensed tocilizumab (Actemra®). The authors also found that the safety profiles were similar. Tocilizumab i...

Biocon announced that the FDA has issued a Complete Response Letter for Viatris (Mylan)’s BLA regarding the bevacizumab jointly developed with Biocon Biologics (biosimilar to Genentech’s Avastin®).  Biocon Biologics said in the announcement that is has submitted a comprehen...

Celltrion and Samsung Bioepis each filed motions seeking joinder of their respective IPR challenges to Regeneron’s 10,888,601 and 10,130,681 patents for Eylea® (aflibercept) with Mylan’s, which was instituted in January 2023.

PTAB also instituted Mylan’s IPR against ...

Samsung Bioepis filed a petition for inter partes review of Regeneron’s US 10,888,601, relating to Eylea® (aflibercept).  In August 2022, Regeneron sued Viatris (Mylan) for infringement of 24 patents relating to Eylea, including the‘601 patent.

Alvotech and STADA announced that EMA has accepted the MAA for Alvotech’s AVT04 biosimilar to Janssen’s Stelara™.  The companies expect the EMA to recommend AVT04 for approval as early as the second half of 2023.  In January 2023, the FDA accepted for review the BLA for AVT...

A new study published in Arthritis Care and Research found that mandatory switching policies were much more effective at driving biosimilar uptake than new start policies.  The study examined 5,884 patients taking infliximab (Johnson & Johnson’s Remicade®, Pfizer’s Infl...

Regeneron announced that the FDA has approved Eylea® (aflibercept) for the treatment of preterm infants with retinopathy of prematurity.  Eylea is now approved in the US to treat five retinal conditions caused by ocular angiogenesis.

Sandoz announced that FDA accepted its BLA for anti-RANKL mAb, biosimilar denosumab.  The application includes all indications included in the Amgen reference products Prolia® and Xgeva®.

Alvotech announced that it has entered into an exclusive agreement with Advanz Pharma for the commercialisation of AVT23 (omalizumab, biosimilar to Novartis’ Xolair™).  The agreement covers the European Economic Area, UK, Switzerland, Canada, Australia and New Zealand.  Alv...