Tuesday, June 06, 2006

Sandoz approval could open the floodgates for biosimilars in US

let's get some floodgates open...even if it takes using the word "biosimilar"...

06/06/2006 - German biopharma firm Sandoz has won a landmark first-of its-kind biosimilar drug approval in the US after a long battle with the US Food and Drug Administration (FDA). The decision could open the floodgates for generics manufacturers in this lucrative market.

Following the green light for Sandoz's copycat biologic growth hormone drug, Omnitrope, the company is now ramping up manufacturing at its fermentation plant in Kundl, Austria and expects to have the drug on the US market by the end of the year.
Omnitrope was approved in Europe in April by the European Commission and is already on the market in Germany, with launches planned in further European countries later this year. The drug was also launched in Australia in November last year.

According to the FDA Omnitrope is not officially called a generic because it is not rated as therapeutically equivalent to any of the other approved human growth hormone (hGH) products. It is however “sufficiently similar” to a product already approved and is thus given the term "follow-on protein product." In Europe the preferred term is ‘biosimilar'.

link to full article

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