What Fresenius Kabi’s PB016 regulatory filings mean for the Entyvio biosimilar market
Fresenius advances PB016 into FDA and EMA review, but competition, manufacturing scrutiny and IV-only positioning will shape its launch path.
Pharma & Biotech
Pharma & Biotech
PB016 versus Entyvio: Polpharma Biologics joins the emerging vedolizumab biosimilar race
Polpharma Biologics’ PB016 enters FDA and EMA review, adding a new vedolizumab biosimilar challenge to Takeda’s Entyvio franchise.
Pharma & Biotech
Teva wants a slice of Roche’s CHF 7bn Ocrevus franchise, but PB018 still has a long road ahead
Teva gains broad rights to PB018 as Polpharma Biologics advances an Ocrevus biosimilar into clinical development for multiple sclerosis.
Pharma & Biotech
Teva and Polpharma Biologics sign global ocrelizumab biosimilar licensing deal
Teva Pharmaceutical Industries Ltd. has secured exclusive global commercialization rights to Polpharma Biologics’ proposed biosimilar to Ocrevus ocrelizumab for multiple sclerosis, covering both intravenous and subcutaneous formulations upon regulatory approval. Polpharma Biologics will remain responsible for development and manufacturing, while Teva will handle regulatory submissions and commercialization across major markets including the United States, Europe,
Pharma & Biotech
Can Polpharma Biologics and Tuteur improve access to autoimmune disease biologics in Latin America?
LATAM autoimmune care needs cheaper biologics. Polpharma Biologics and Tuteur are betting a biosimilar deal can shift access.