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Biosimilars: The Time Has Come

Biosimilars' time has come--in Europe, at least. The European regulators asserted during a workshop in Paris at the beginning of December that biosimilars guidelines will be finalized before mid-2006. This will open up a market which could be worth $8 billion within five years in the EU, according to the European Generic Association (EGA).

In Europe, at least. This was the subtext of a joint workshop organized by the European Medicines Agency, EMEA, and the Drug Information Association in Paris at the beginning of December. The event brought together all stakeholders in the biosimilars debate—innovators, generic firms, regulators, physicians and patient groups--to discuss remaining areas of uncertainty in the draft guidelines on the development and approval of biosimilars, which EMEA issued last year. (See "Biosimilars: EMEA Wants Approvals," IN VIVO, September 2005 Also see "Biosimilars: EMEA Wants Approvals" - In Vivo, 1 September, 2005..)

There was plenty to discuss. Well before the exchanges were complete, however, EMEA asserted that the guidelines will be finalized...

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