CHMP positive opinion for Bomyntra, and Conexxence biosimilars for the treatment of osteoporosis and other bone-related conditions – Fresenius Kabi

Fresenius announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA has issued a positive opinion for its denosumab biosimilar candidates, Bomyntra and Conexxence (Denbrayce) for the treatment of osteoporosis and other bone-related conditions.

The biosimilars are recommended for approval for all indications of the reference products Prolia (denosumab) and Xgeva (denosumab) from Amgen. Bomyntra is a biosimilar medicinal product.  It is highly similar to the reference product Xgeva (denosumab), which was authorised in the EU on 13 July 2011. Data show that Bomyntra has comparable quality, safety and efficacy to Xgeva (denosumab).

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.