BioWorld International Correspondent

LONDON - Europe has opened the floodgates to generic biopharmaceuticals, agreeing that the human growth hormone Omnitrope, manufactured by Sandoz GmbH, is equivalent in quality, safety and efficacy to the registered originator product.

The first positive opinion for a biogeneric needs to be endorsed by the European Commission, but it would be unlikely to overturn the recommendation of approval by the European Medicines Agency (EMEA).

Following on from the decision, EMEA said it is expecting eight applications to register biogenerics in 2006. Biopharmaceuticals with global sales of more than $10 billion annually will come off patent by 2007.

Andreas Rummelt, CEO of Sandoz, said, "Omnitrope will contribute to cost savings in health care systems, and we are confident that the European Commission will now grant marketing authorization."

The move by EMEA leaves the FDA trailing on the issue of approving biogenerics. Sandoz, of Holzkirchen, Germany, filed Omnitrope (somatropin) with the FDA in July 2003. In September 2004, the FDA said that although there were no deficiencies in the application, it could not reach a decision. That was because of uncertainty around the scientific and legal issues involved in registering biogenerics, also called follow-on protein products.

Although it since has held public workshops to discuss the issue, the FDA is yet to set out an approvals pathway.

In September, Sandoz filed a lawsuit against the FDA, claiming it illegal to leave an application in limbo. That lawsuit still is pending, and Rummelt said, "With Omnitrope's positive status in Europe, we now hope the FDA will finally move in granting a marketing authorization for the U.S."

That is not to say that Omnitrope has had an easy time with European regulators. In June 2003, EMEA recommended it for approval, but the commission refused marketing authorization on legal grounds. However, the legal pathway for approval was agreed on subsequently, and Sandoz submitted a second application in July 2004, resulting in the recommendation last week that it be approved.

The pioneers of the biotech industry have fought hard against the approval of generics, claiming biopharmaceuticals cannot be copied in the same way as chemical drugs. EMEA conceded exact copies are impossible and made that explicit by ditching the term biogeneric in favor of biosimilar.

Alongside legal moves to allow the registration of biosimilars, EMEA issued a series of general guidelines covering quality and safety issues, and specific guidelines for four products - erythropoietin, granulocyte-colony stimulating factor, insulin and human growth hormone. While those requirements are not as exacting as the route to registration for originator products, they are more complex and costly that the process of registering small-molecule generics.

For EMEA, the recommendation that Omnitrope be approved draws to a close a five-year consultation process to establish rules for the development and approval of biosimilars.

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