The European Medicines Agency has completed the process of drawing up its guidelines for companies developing similar biological medicinal products – or biosimilars – clearing the way for lower-cost versions of off-patent biologic drugs.

The legislation allows biosimilars to be approved without a full application package, providing studies showing that they have the same basic safety and efficacy profile as the pioneer drug. Previously, copies of off-patent biologic drugs were blocked from the market because it is not possible to make a biologic by one production process that is completely identical to another using a different process. Special criteria to show equivalence had to be drawn up.

And the completion of the work is timely, with two biosimilar versions of human growth hormone (somatropin) already recommended for approval in the EU and a number of others under regulatory review at the EMEA.

The agency said it now has four additional guidelines to add to the general regulatory document on similar biological medicinal products published in September 2005.

The new guidelines cover quality, non-clinical and clinical issues, with specific annexes giving guidance for medicines containing insulin, somatropin and recombinant granulocyte-colony stimulating factor. An annex for medicines containing epoetin will also be available shortly. They come into effect from June 1.

The new legislation opens up the market for lower-cost versions of a number of off-patent biologic drugs that collectively represent a global market of $20 billion or more.

- Meanwhile, the EMEA has also published two concept papers related to biosimilars. The first covers comparability of biotechnology-derived medicinal products after a change in the manufacturing process, while the second is on immunogenicity assessment of therapeutic proteins. A public consultation period on these two papers expires on June 1.