A biosimilar, as the name indicates, is similar to another biologic that has already been approved for use. In 2006, Sandoz received the first approval in the European Union for a biosimilar, Omnitrope®, a version of somatropin, or human growth hormone. The company subsequently received EU approval for a second biosimilar, Binocrit®, which is a version of epoetin alfa for regulating the formation of red blood cells. While Europe already has established a regulatory pathway for biosimilars, the U.S. remains engaged in discussions on draft guidance documents, definitions of study requirements, and intellectual property issues. Some industry analysts say that biosimilars can cost 20–25% less than the original product.
Do you think the FDA is taking too long in establishing final regulations for the approval of biosimilars in the U.S.?