Monday, August 2, 2010

Amgen to test safety and efficacy of biosimilar

Epogen will soon have competition. Amgen is testing it's biosimilar version of the drug. Contrary to other biosimilar tests, the study of the safety and the efficacy of the drug will be tested first. Then, Amgen will turn it into a Phase III trial next year.

Sumant Ramachandra, a senior vice president at Hospira, commented:
"This trial marks a key milestone for Hospira's biosimilars program. Congressional approval of a regulatory pathway for biosimilar drugs in the U.S. set the stage for our development of a U.S. biosimilar EPO. We hope to leverage our leadership in generics and our biosimilars experience in Europe to make affordable, safe and effective biosimilars available to U.S. patients and their healthcare providers once patents expire over the next several years."

Fierce Biopharma has more on the biosimilar from Amgen.

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