Celltrion wins positive CHMP opinions for 3 biosimilars in EU

Celltrion said Monday that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has issued positive opinions recommending marketing authorizations for three of its biosimilar candidates. 

These include Avtozma (CT-P47, tocilizumab), a biosimilar of Actemra (RoActemra in Europe); Eydenzelt (CT-P42, aflibercept), a biosimilar of Eylea; and two biosimilars of Prolia and Xgeva (denosumab), branded as Stoboclo and Osenvelt (CT-P41).

Avtozma is recommended for all indications of its reference product, including rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), juvenile idiopathic polyarthritis (pJIA), and giant cell arteritis (GCA). Eydenzelt is approved for various retinal disorders such as wet age-related macular degeneration (AMD) and diabetic macular edema (DME). Stoboclo and Osenvelt have been endorsed for the treatment of osteoporosis and cancer-related bone complications, respectively.

The CHMP recommendations were supported by clinical trials that demonstrated the biosimilars' equivalence to their reference products in efficacy, safety, pharmacokinetics, and immunogenicity. 

The European Commission (EC) will now decide on final marketing authorizations. If approved, these products will be available across EU member states, completing Celltrion's goal of building an 11-product portfolio ahead of its 2025 target. The company also aims to expand this portfolio to 22 biosimilars by 2030.

Celltrion emphasized its plans to leverage the expanded portfolio to diversify its revenue streams and enter new therapeutic areas such as ophthalmology and bone disorders, estimating the market potential of its current portfolio at approximately 135 trillion won ($94 billion).