European Performance Tracker

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

Doxecitine/doxribtimine, UCB’s investigational orphan drug for pediatric and adult patients with thymidine kinase 2 deficiency, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include Alhemo, Novo Nordisk's product for the prevention of bleeding in patients with hemophilia A and FVIII inhibitors or hemophilia B and FIX inhibitors.

A total of 141 products have made it onto the European Medicines Agency’s PRIME (priority medicines) scheme since 2016 and over 370 applications have been denied entry.

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Elinzanetant, Bayer’s investigational treatment for hot flashes in menopausal women, is among the latest drugs that have been filed for review by the European Medicines Agency for potential EU marketing approval.

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add four new products, including Anzupgo, LEO Pharma's treatment for moderate to severe chronic hand eczema in adults for whom topical corticosteroids are inadequate or inappropriate.

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.