Update on Recent International Biosimilar Approvals

Approval of Fresenius Kabi’s Tocilizumab Biosimilar in the EU:  On September 19, 2023, Fresenius Kabi announced that the European Commission (EC) granted marketing authorization for TYENNE (tocilizumab), a biosimilar referencing Roche’s ROACTEMRA.  TYENNE is the first tocilizumab biosimilar approved in the EU.  TYENNE received approval for both subcutaneous (prefilled syringe and autoinjentor) and intravenous formulations for the treatment of various inflammatory and immune mediated conditions, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis, cytokine release syndrome (CRS) as well as for the treatment of COVID-19.  TYENNE is Fresenius Kabi’s third biosimilar product approved in the EU, following previous approvals of its biosimilars IDACIO (adalimumab) and STIMUFEND (pegfilgrastrim).

Approval of Biocon’s Aflibercept Biosimilar in the EU:  On September 20, 2023, Biocon Biologics Ltd., a subsidiary of Biocon Ltd., announced that the EC granted marketing authorization for YESAFILI (aflibercept), a biosimilar referencing Regeneron’s EYLEA.  The EC decision follows the positive opinion issued earlier this year by the European Medicine’s Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending approval of YESAFILI.  YESAFILI is intended for the treatment of neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV).

Approval of Alvotech’s Ustekinumab Biosimilar in Japan:  On September 25, 2023, Alvotech announced that its commercialization partner in Japan, Fuji Pharma Co., received marketing approval in Japan for AVT04 (ustekinumab), a biosimilar to Janssen’s STELARA.  According to Alvotech, this “is the first biosimilar to STELARA to be approved for sale in global markets.”  Alvotech states that “AVT04 was developed using an Sp2/0 host cell line and is manufactured by Alvotech using a continuous perfusion process,” and “[t]he Sp2/0 host cell line allows for more efficient sialylation of the molecule as compared to Chinese hamster ovary (CHO) cells and is the same type of host cell line used to produce STELARA.”  AVT04 is the first biosimilar approved under the commercial partnership between Alvotech and Fuji.