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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...

MSD announced that Ph III trials of Keytruda® (pembrolizumab) in combination with chemotherapy met its primary endpoint of progression-free survival for the treatment of stage III-IV or recurrent endometrial carcinoma.  Reportedly, the safety profile of Keytruda was consist...

Fresenius Kabi and Formycon AG announced they have reached a global license agreement to commercialise FYB202, biosimilar to Johnson & Johnson’s Stelara®. Under the agreement, Fresenius will have the exclusive commercialisation rights in key global markets, whilst Formy...

Roche’s Genentech is investing US$450M in expanding its biologics capabilities at Oceanside California. Approximately US$280M will go toward building a new biologics manufacturing facility that will begin operations in 2025. The new facility will produce protein-based medic...

Reuters reported that it expects only limited cost savings to result from Amgen’s launch of Amjevita® (biosimilar to AbbVie’s Humira® adalimumab) in the US in January this year.  Reuters reported that while Amgen launched Amjevita at two price points (one with a 5% discount...

The much anticipated launch of the first US Humira biosimilar occurred with Amgen launching Amjevita® (adalimumab) on 31 January 2023, pursuant to its settlement agreement with AbbVie which was penned in September 2017.  Amjevita® is the first adalimumab biosimilar to be la...