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

New medicines under evaluation at the European Medicines Agency.

The Pink Sheet’s list of EU centralized approvals of new active substances now includes three new products including Janssen's Erleada, a next generation oral androgen receptor inhibitor for treating adults with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (e.g., medicine, vaccine, biologic).

In 2018, the European Medicines Agency considered 24 requests from drug companies for fast-track review of their planned marketing authorization applications. The agency has granted at least nine requests, eleven have been rejected and the results of four have yet to be disclosed.

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.