High expectations for new US biosimilars following FDA guidance documents

In light of the upcoming FDA guidance for biosimilar approval, Novation, health care supply chain expertise and contracting company, has released a white paper, "Biosimilars – FDA Guidance Update," to help hospitals and health care providers better understand the key components of the Food and Drug Administration's draft guidance documents and suggested next steps.

"Experience with biosimilars in the European Union suggests that these 'highly similar' versions of reference biologics could result in price decreases of 20% to 30%," said Steven Lucio, director of clinical solutions, pharmacy, at Novation, adding: "In spite of the uncertainty about the exact timing of biosimilar availability, lower-cost alternatives to commonly used biologics will receive market approval in the near future."

The paper includes a discussion of key elements of the FDA's guidance including: