The Committee for Medicine Products for Human Use (“CHMP”) recommended 14 medicines for European Medicines Agency Approval (“EMA”) approval (“marketing authorization”), during its monthly meeting on July 22-25, 2024.  Notably, the committee adopted positive opinions for the following 6 biosimilar products:

• Samsung Bioepis’s EKSUNBI (ustekinumab), Formycon AG’s FYMSKINA (ustekinumab), and Fresenius Kabi Deutschland GmbH’S OTULFI (ustekinumab) for the treatment of plaque psoriasis, pediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease.  The products were deemed highly similar to Janssen’s STELARA (ustekinumab), which was authorized in the EU on January 15, 2009.
• Reddy Holding GmbH’s ITUXREDI (rituximab) for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis and pemphigus vulgaris.  ITUXREDI was deemed highly similar to Roche’s MabThera (rituximab), which was authorized in the EU on June 2, 1998.
• Midas Pharma GmbH’s Ranibizumab Midas for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion and visual impairment due to choroidal neovascularization.  RANIBIZUMAB MIDAS was deemed highly similar to Genentech’s LUCENTIS (ranibizumab), which was authorized in the EU on January 22, 2007.   RANIBIZUMAB MIDAS is a “duplicate” of Ranivisio, which was authorised in the EU on August 25, 2022.  In the EU, “duplicate” medicines have identical composition and pharmaceutical form.
• Prestige Biopharma Belgium BVBA’s TUZNUE (trastuzumab) for the treatment of breast and gastric cancer.  TUZNUE was deemed highly similar to Genentech’s HERCEPTIN (trastuzumab) which was authorized in the EU on August 28, 2000.

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