Biosimilars Market Is at a Critical Turning Point

The next 12 to 18 months are likely to be a critical time for an industry at the forefront of 21st century health care — biosimilars. Congress enacted landmark legislation in 2010 creating an expedited FDA approval pathway for these products, and the biosimilars industry has begun to grow rapidly.

But the U.S. Food and Drug Administration and the courts are now considering several important aspects of the biosimilars statutory and regulatory framework, and their decisions will determine the industry's full potential as it comes of age.

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Diana L. Courson
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