Current State of Biosimilars in the United States

The FDA has had the regulations to approve biosimilars in place for two years.  Yet, as Pharmalot points out, it is yet to receive an application for approval. Gillian Woollett, a vice president at Avalere Health, a healthcare consulting firm, took some time to share her views on the current state of biosimilars.  She points out that there are 149 biologics approved for use in the United States and over 900 are in clinical development.  Those who take the biologics on a daily basis pay about $22 a day.  The market is expected to reach $150 billion by 2016.  It costs $250 million to develop a biosimialr.  So does this open the door for biologics in the US?

In Europe, there are already 14 biosimilars approved and on the market, many out sell their originator biologics.  However, Woollett is quick to point out that in the EU, the EMA doesn't give complete interchangeability to biologics and biosimilars.  The United States FDA does have this ability.  But at the end of the article, Woollet points out that the approval is ultimately about the patient, and many things will be determined by how much the biosimilars will cost who will be paying for it.

At the Business of Biosimilars & Generic Drugs this September, Hoss Dowlat, Vice President, Regulatory Affairs, PHARMA-BIO CONSULTING will be on hand to present "Experiences from Developing Biosimilars for EMA: Unique Perspectives from Growth Hormones to Monoclonal Antibodies,"looking at how the US and European markets may differ and how to coordinate a roll out between the two markets.  To find out more about this session and the program, download the brochure here. If you'd like to join us this September 10-12 in Boston, register today and mention code XP1786BLOG to save 25% off the standard rate.

Do you believe we'll see a biosimilars presented for approval in the US in the next year? Why or why not?

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