Generic challenger to Eprex approved

pharmafile | September 6, 2007 | News story | Sales and Marketing |   

The first ever biosimilar version of blockbuster anaemia drug epoetin alfa has been approved in Europe.

The drug is marketed by Amgen as Epogen in the US, while in Europe Janssen-Cilag markets it as Eprex.

Epoetin alpha is also clinically the same as Roche's NeoRecormon epoetin beta, meaning these products, and other similar ones, such as Amgen's Aranesp, will also face stiff competition from the new generic.

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Sandoz, the generics arm of Novartis has received the marketing approval for its version of epoetin alfa, which currently generates around $7 billion in revenue under a variety of branded versions.

More than 250,000 patients in Europe are estimated to be treated with epoetin alfa, which regulates the formation of red blood cells, the market being worth an estimated $600 million in Europe.

"We are pleased that the European Commission has taken the final step in approving our biosimilar epoetin alfa for marketing in Europe, and we will quickly bring this product to market for the patients and physicians who need it," said Andreas Rummelt, chief executive of Sandoz. "We are committed to continue making high-quality and cost-effective biosimilars available and have several projects in our pipeline."

The EMEA granted the first ever biosimilar licence for a leading product in a major market when it approved Sandoz's human growth hormone Omnitrope in April 2006.

 

 

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