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May 15, 2011 (Vol. 31, No. 10)

Biosimilars Proceed with Caution from Starting Gate

Market Poised for Explosive Growth in the Coming Years as Hurdles Are Surmounted

  • Biosimilars were briefly (albeit unofficially) known as biogenerics, then follow-on biologics, before the current nomenclature was adopted. The U.S. FDA website defines biosimilars as “biological prescription drugs that are demonstrated to be ‘highly similar’ (biosimilar) to or ‘interchangeable’ with an FDA-approved biological product.” Yet some experts believe the designation ...

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