Europe's biosimilar mess

Novartis AG's goal of having the first follow-on biologic on the European market has been dealt a major setback. Instead of the rapid trip to pharmacy shelves the company expected following a positive CPMP recommendation for its Omnitrop human growth hormone last June, the company's generics subsidiary, Sandoz, now is in the midst of an unusual legal challenge to the European Commission's subsequent refusal to approve the product.

A document released as a result of a legal action, as well as hints from European regulators, indicate that something went wrong last winter. ...