BioWorld International Correspondent

BRUSSELS, Belgium - New guidance on authorization of copies of biotech drugs has been welcomed by the European biopharmaceutical industry. EuropaBio said that a question-and-answer document released by the European Medicines Agency will help reinforce protection for innovations.

The agency said biosimilars - generic versions of biological medicines - "are similar but not identical" to the original. It accordingly warned against using copies instead of innovator products without the opinion of a qualified health care professional.

"Due to the complex method of production of biological medicines, the active substance may differ slightly between the biological reference and the biosimilar medicine," said the agency, and studies are required to "demonstrate that there are no meaningful differences between the biosimilar and the biological reference medicines in terms of safety or efficacy."

EuropaBio has interpreted the guidance as an endorsement of its own view of the uniqueness of the medicines produced by its innovative companies. The industry association also expressed its satisfaction at the "effective advice against automatic substitution of one biological medicine over another."

Speaking on behalf of the industry association, Serono's Andrea Rappagliosi said: "This document provides some clarification on the use of biosimilars and underscores the importance of the biosimilar regulatory pathway established in 2004."

But industry executives want to see the agency go further.

Thomas Bols, director of governmental affairs in Europe for Amgen Inc., urged European regulatory authorities to address outstanding issues on naming of products, interchangeability, and labeling of biosimilars.

The EU's medicines agency stressed that biosimilar medicines are subject to the same authorization requirements as other medicines, on the basis of a scientific evaluation of efficacy, safety and quality.

And while some information already available from the original product does not need to be reproduced, "legislation defines the studies that need to be carried out to show that the biosimilar medicine is similar and as safe and effective as the biological reference medicine," the guidance noted.