European Biologics Regulatory Updates

Bayer’s aflibercept 8 mg recommended for approval in Europe: On November 10, 2023, Bayer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending aflibercept 8 mg for approval for extended treatment intervals in two major retinal eye diseases, neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). The CHOMP recommendation is based on positive results from the PULSAR clinical trial in nAMD and the PHOTON trial in DME. The final decision from the European Commission is expected in the coming months.

Aflibercept 8 mg was jointly developed by Bayer and Regeneron. According to the press release, Regeneron maintains exclusive rights to EYLEA (aflibercept 2 mg) and aflibercept 8 mg in the United States, and Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of EYLEA (aflibercept 2 mg).

Biocon Biologics receives approval in the UK for Aflibercept biosimilar: On November 13, 2023, Biocon Biologics Limited announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization for YESAFILI, a biosimilar aflibercept. The European Commission (EC) granted market authorization approval for YESAFILI received in September 2023. A company spokesperson stated “We are very pleased to receive the MHRA approval for YESAFILI®, biosimilar aflibercept, which will enable us to address the needs of patients impacted by macular degeneration and diabetic retinopathy, in the UK. This approval will expand our biosimilar offerings to patients across the globe, building on our oncology and diabetes product portfolios.”

STADA and Alvotech receive positive CHMP opinion for ustekinumab biosimilar: On November 11, 2023, partners STADA and Alvotech announced that the CHMP adopted a positive opinion for UZPRUVO (AVT04), a biosimilar candidate to STELARA (ustekinumab). The positive CHMP opinion for UZPRUVO marks the first time that the EMA has proposed authorizing a biosimilar to STELARA. According to the announcement, a marketing authorization with indications for Crohn’s disease, psoriasis and psoriatic arthritis would be valid across all European Union (EU) member states, as well as in Iceland, Liechtenstein and Norway. STADA’s Global Specialty Head, Bryan Kim, commented: “This positive CHMP opinion puts STADA and Alvotech in prime position to improve patient access in the ustekinumab and interleukin inhibitor markets. As a pioneer in driving biosimilar competition, STADA looks forward to offering Europe’s gastroenterologists, dermatologists and rheumatologists a valuable and cost-effective treatment option.”