On February 15, Alvotech announced that it reached more settlement agreements with Johnson & Johnson for ATV04, Alvotech’s biosimilar to STELARA (ustekinumab). The settlements cover Canada, the European Economic Area, and Japan, clearing the way for Alvotech to launch AVT04 in those markets, where AVT04 has already received regulatory approval. …
On January 10, Alvotech announced that the European Commission (EC) issued a marketing authorization to its European commercialization partner, STADA, for UZPRUVO (AVT04), a biosimilar referencing STELARA (ustekinumab). The authorization covers all European Economic Area countries, as well as Iceland, Liechtenstein, and Norway. UZPRUVO is the first ustekinumab biosimilar to…
On March 30, 2022, Fresenius Kabi announced that the European Commission approved STIMUFEND, a pegfilgrastim biosimilar referencing NEULASTA, for patients with non-myeloid cancer who are receiving myelosuppressive chemotherapy. STIMUFEND, to launch in a prefilled syringe, is Fresenius’s first approved molecule in its oncology biosimilar portfolio and second biosimilar approved in…
On January 10, 2022, Alvotech Holdings S.A. (“Alvotech”) and JAMP Pharma Group (“JAMP Pharma”) announced that Health Canada granted marketing authorization to JAMP Pharma for a high-concentration biosimilar to Humira® (adalimumab) developed by Alvotech. The biosimilar, also referred to as AVT02, will be marketed in Canada as SIMLANDI (100 mg/mL…