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Analysis: First FDA Biosimilar Filing


Avalere impressions on the first FDA biosimilar filing.

1. The first FDA filing of a biosimilar is a key step to the U.S. having biosimilars. With their approval (maybe as early as 1Q15) we will learn whether or not these new market entries will provide competition in the specialty drug market and enable payers to hold down costs.

2. We expect FDA to apply the same standard of safety, purity and potency to biosimilars as to any other biologic. Also the same quality standards (cGMP) will apply.

3. FDA approval will be the next step. We have yet to see how patients and their healthcare providers will react to the availability of biosimilars .While the biosimilars first approved in the U.S. will likely be those already approved in Europe, differences in the U.S. health care system mean that adoption will follow different patterns.

4. Avalere has done extensive modelling of the market dynamics associated with introduction of biosimilars to U.S. markets. Savings to payers, providers and consumers will be contingent on market pricing of new products, provider and patient comfort with prescribing, federal and state regulatory factors and the extent of branded and biosimilar competition.


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