Call for "Workable" Guideline for Biosimilar mAbs

The director-general of the European Generic Medicines Association (EGA), Greg Perry, emphasized the need for European Union biosimilar guidelines for monoclonal antibodies (mAbs), as well as for a harmonized, global approach to biosimilars in general, at the agency’s 8th International Symposium on Biosimilar Medicines last week.

“As regulations fall into place worldwide, there is a need to reach a global agreement on criteria and guidelines for biosimilar medicines in the interest of patients and the better availability of high quality medicines,” said Perry, according to an EGA press statement about the symposium.

Progress toward biosimilars regulation has been made in several countries outside the EU, including Australia, Canada, Japan, Turkey, and the US. EGA believes the time is fast approaching to undertake a “benchmarking” exercise. “A consistent, scientific global approach is essential to move towards true global development of biosimilars medicines,” said the EGA statement.

Steps toward a global, harmonized regulatory approach may already be in sight, with the World Health Organization (WHO) scheduled to finalize its guidelines on the evaluation of similar biotherapeutic products in 2011. According to EGA, the guidelines will be founded on the same basic scientific principles as in the EU.

In particular, Perry highlighted the importance of mAbs at the symposium and the need for “workable” guidance in this area. According to Peter Gaskin, a Principal Consultant at Aptuit Consulting, many companies are already targeting mAbs for biosimilar development. In a recent article written for Pharmaceutical Technology Europe, Gaskin explained that EU guidelines for biosimilar mAbs would be a significant development, particularly because mAbs represent some of the biggest selling products.

“If healthcare systems are to continue to function long-term, we must address the importance of biosimilar mAbs next,” said Perry. “Science for mAbs is already here today and our industry is expecting a workable guideline.”

See a related PharmTech article:
Bioimilars: Too steep a mountain to climb? (PharmTech Europe)