International Biosimilar Approval and Launch Updates

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 Europe.  Fresenius has also filed its pegfilgrastim biosimilar candidate for regulatory approval with the U.S. Food and Drug Administration (FDA), and the application is currently under review.

Earlier this week, Celltrion Healthcare announced the launch of YUFLYMA, a high-concentration (100mg/mL), low-volume, citrate-free biosimilar to HUMIRA (adalimumab), as a new treatment option in Canada.  As we previously reported, the company originally received marketing authorization for YUFLYMA from Health Canada on December 24, 2021.  YUFLYMA has ten indications for the treatment of chronic inflammatory diseases and is available in two latex-free device types: Auto-injector and Pre-filled Syringe with Safety Guard.

Just yesterday, JAMP Pharma Group (“JAMP Pharma”) announced the launch of SIMLANDI, a high-concentration, low-volume, citrate-free biosimilar to HUMIRA (adalimumab) developed and manufactured by Alvotech. As we previously reported, JAMP Pharma and Alvotech originally received marketing authorization for SIMLANDI from Health Canada on January 10, 2022.  SIMLANDI (100mg/mL adalimumab, in 40mg/0.4mL and 80mg/0.8mL formulations), is the first biosimilar to be commercialized by BIOJAMP, a division of JAMP Pharma.