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Omnitrope Hiccup: How Not To File For Biogeneric Approval in Europe

 
• By Melanie Senior

Sandoz's Omnitrop was expected to become the first marketed biogeneric in Europe, following a positive CPMP recommendation last June. But in March 2004 it emerged that the European Commission, in an unusual move, had blocked the drug's approval late last year. While certainly a setback for Sandoz, and hardly comforting to the rest of the sector, the events appear to result from a misunderstanding over the legal basis of the application, rather than from any deeper reluctance among European lawmakers to approve biosimilar products.

In June 2003, biogenerics firms in Europe took heart when the European Medicines Evaluation Agency (EMEA) recommended approval of Novartis AG 's recombinant growth hormone, Omnitrop. This would likely be the first so-called "biosimilar" product to market, reflecting regulators' willingness to embrace generic copies of marketed biologicals and paving the way for plenty of others in the pipeline. At last some optimism within a young industry that has already encountered far more cost and complexity than it bargained for, in particular with regard to the scope and size of clinical trials necessary to prove equivalent safety and efficacy to existing products. (See "Biogenerics: Threat or Opportunity?" In Vivo Europe Rx, October 2003 Also see "Biogenerics: Threat or Opportunity?" - In Vivo, 1 October, 2003..)

The good mood didn't last long. An EU document published in March 2004 reveals that the European Commission (EC) had five months earlier refused to endorse the EMEA's recommendation, on...

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