EUCOPE Opposes Spain’s Order Grouping Biosimilars with Generics

October 22, 2014

A trade group of small to medium-sized European brand drugmakers has criticized a Spanish government order that may allow biosimilars to be interchanged with their reference product in the same way that generics may be substituted for brands.

Spain’s July 10 ministerial order creates a regulatory category for biosimilars that treat them as if they were generics, the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) said this week. The group criticized the order on grounds that biosimilars are not interchangeable, since biosimilars, unlike generics, are not equivalent to the innovator products.

In cases of on-going medical treatments, biosimilar substitution should only be allowed after an accurate scientific finding of interchangeability is established, and only upon the direction of a treating physician, EUCOPE argued in a draft position paper released this week.

In general, the group also called for giving biosimilars separate and unique proprietary names, rather than sharing the international non-proprietary name.

EUCOPE’s recommendations echo those of another trade group EuropaBio, which earlier this month called for distinguishable non-proprietary names for all biological medicines, including biosimilars, as a means to further enhance effective pharmacovigilance and patient safety. — Jonathon Shacat

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.