Goodwin
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 from July 22-25, 2020. 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. ITUXREDI was deemed to be highly similar to Roche’s MabThera (rituximab), which had been approved in the EU on June 2, 1998. ITUXREDI is deemed to be highly similar to Roche MabThera’s (rituximab), approved in the EU on 2 June 1998.Midas Pharmaceutical GmbH’s
- Ranibizumab midas to treat neovascular age-related macular (wet RANIBIZUMAB MIDAS has been deemed to be highly similar to Genentech’s LUCENTIS, which was approved in the EU on January 22, 2007 (ranibizumab). RANIBIZUMAB MIDAS was deemed to be a “duplicate”, of Ranivisio which was approved in the EU on 25 August 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 is a highly similar drug to Genentech HERCEPTIN, a trastuzumab approved in the EU by August 28, 2000.
