CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars: On January 30, 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending the grant of marketing authorizations for three biosimilar products—Amgen’s PAVBLU and SKOJOY, and CuraTeQ Biologics’ DYRUPEG.
Amgen’s PAVBLU and SKOJOY, both biosimilars referencing EYLEA (aflibercept), are indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), and visual impairment due to myopic choroidal neovascularisation (myopic CNV). PAVBLU is further indicated for the treatment of visual impairment due to diabetic macular oedema (DME). If approved, Amgen’s PAVBLU and SKOJOY would be the fifth and sixth aflibercept biosimilars approved in the EU, following the approval of Biocon’s YESAFILI, Sandoz’s AFQLIR, Samsung Bioepis’s OPUVIZ, and Formycon’s FYB203.
CuraTeQ Biologics’ DYRUPEG, a biosimilar referencing NEULASTA (pegfilgrastim), is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). According to the press release, CuraTeQ expects the CHMP positive opinion to translate into a formal decision of approval by the European Commission in April 2025.
Celltrion Launches STEQEYMA (ustekinumab) in Additional European Markets: On January 23, 2025, Celltrion announced the launch of STEQEYMA, a biosimilar referencing STELARA (ustekinumab), in France. Celltrion had launched STEQEYMA in Italy and Spain earlier in January 2025, in the U.K. in December 2024, and in Germany and the Netherlands in November 2024.
As we previously reported, the FDA approved STEQEYMA in the United States and Celltrion is expected to begin marketing its biosimilar in February 2025.