BioWorld International Correspondent

LONDON - Sandoz International filed a lawsuit against the FDA in a bid to force a ruling on the new drug application for Omnitrope, Sandoz's biogeneric form of recombinant human growth hormone.

That matches a similar suit filed in Europe after European regulators turned down Omnitrope late in 2003.

Sandoz, a subsidiary of Novartis AG, of Basel, Switzerland, filed Omnitrope 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, or follow-on protein products, as the FDA terms copies of recombinant proteins.

A Sandoz spokesman said, "Since then, nothing has happened at all on the FDA front. There has been no progress, and that is why we issued the lawsuit."

The FDA did hold public workshops to assess scientific considerations related to developing biogenerics in September 2004 and then in February. "We participated in those meetings," said the Sandoz spokesman. "There were no new items raised and no new science."

Under both the Federal Food Drug and Cosmetic Act and the Food Prescription Drug User Fee Act, the FDA is required to either approve or reject NDAs, and cannot leave a drug in limbo. The lawsuit, filed in the U.S. District Court for the District of Columbia, aims to reverse the FDA's failure to rule on Omnitrope in accordance with the legal requirement.

While the lawsuit is still pending in Europe and there has been no progress on the Omnitrope application, the spokesman said the situation has become clearer. This is a result of the European Medicines Evaluation Agency (EMEA) issuing final guidelines outlining the general principles for the development and assessment of marketing authorization applications for biosimilars (the preferred terms for biogenerics in Europe).

The guidelines include detailed approval requirements for human growth hormone, insulin, erythropoeitin and granulocyte-colony stimulating factor. "Our first reaction [to the guidelines] was favorable," said the Sandoz spokesman.

Another biogenerics manufacturer, GeneMedix plc, of Newmarket, UK, also has reacted favorably to the guidelines. Paul Edwards, CEO, said they are broadly in line with expectations and reduce the risk of non-compliance with the registration pathway.

GeneMedix recently completed an erythropoeitin manufacturing facility in Tullamore, Ireland, which now is producing commercial-scale batches. The EMEA guidelines will require the company to carry out a 12-month immunogenicity study in 300-plus patients, extending the overall clinical trial by three to six months, but Edwards said that would not disadvantage GeneMedix, as any competitors will have to carry out the same studies.

Interested parties have until the end of October to comment on the EMEA guidelines.

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