However, he also urged a workable guideline for monoclonal antibodies is now urgently needed as the “science for monoclonal antibodies is already here today”.

Mr Perry added that “as regulations fall into place around the world, 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”.

Both the EMA and the WHO have prepared guidelines to facilitate regulatory approval of biosimilars in both the EU and globally.

The EMA currently has concept papers in the pipeline for European regulation of recombinant interferon beta and follicle stimulation hormone, as well as the long-anticipated guideline for monoclonal antibodies.

The WHO also has a global guideline on similar biotherapeutic products, which is based on the same basic scientific principles as in the EU.

“For the sake of Europe’s patients”, Mr Perry concluded that “further support for wider use of biosimilar medicines was required, including increased awareness and information, use of incentives and a rational approach towards interchangeability”.

Related articles

Global guidelines for biosimilars

EU guidelines for biosimilars

References

EGA Press Release. EGA calls for a workable guideline for biosimilar monoclonal antibodies and a consistent scientific global approach towards biosimilar medicines. 2 September 2010

EMA. Concept paper on the development of a guideline on similar biological medicinal products containing monoclonal antibodies. EMEA/CHMP/BMWP/632613/2009. 22 October 2009

WHO. Guidelines on evaluation of similar biotherapeutic products (SBPs)