EMEA COULD SOON APPROVE FIRST FOLLOW-ON BIOLOGIC

The European Medicines Agency (EMEA) could approve Sandoz' generic biologic Omnitrope in April and Swiss firm BioPartners' follow-on product Valtropin by May, experts familiar with the issue told FDAnews.

The EMEA's Committee on Medicinal Products for Human Use (CHMP) recommended approval for Omnitrope in January and Valtropin in February. Omnitrope is a version of Pfizer's human growth hormone Genotropin (somatropin recombinant), and Valtropin is a version of Eli Lilly's growth hormone Humatrope (somatropin recombinant).

The EMEA typically makes a decision within 90 days of CHMP's recommendation for approval, said attorney Richard Kingham, a partner at law firm Covington & Burling.

The EMEA does not have to follow the committee's recommendation, but the law requires the agency to provide a detailed explanation if it decides not to do so. CHMP's opinion "carries more weight" than an FDA advisory committee vote, said Linda Horton, a partner at law firm Hogan and Hartson, during a recent FDAnews audioconference.

This would be CHMP's second approval recommendation for Omnitrope. The panel recommended the product in June 2003, but EU regulators last year rejected the application on legal grounds related to the drug's selected approval pathway, Sandoz said.

The EMEA recently finalized product-specific guidance for the manufacture of some biogenerics. The five final guidelines are for products containing insulin, somatropin and recombinant granulocyte-colony stimulating factor. While these documents are a step forward, the postapproval reports the EMEA will issue following approval of the first biogenerics will provide more complete information on what the agency expects from makers of such products, Kingham said.

Those reports should be out shortly after the decisions granting approval are issued, he added.

"We aren't going to get a real concrete sense of what they expect until the EPARs [European Public Assessment Reports] are issued," Kingham said. Many of the details "still need to be worked out in the context of specific marketing authorization applications," he said.

The EMEA guidelines and concept papers can be found at http://www.emea.eu.int/pdfs/general/direct/pr/8456106en.pdf (http://www.emea.eu.int/pdfs/general/direct/pr/8456106en.pdf). (http://www.fdanews.com/did)