Friday, September 24, 2010

New term I like: “bio-betters”

As Congress approves a regulatory pathway for “biosimilars,” start-ups think the bigger opportunity is “bio-betters.”
  • Biosimilars are the closest thing possible to generic versions of biotech drugs. Unlike conventional small-molecule drugs made through chemical synthesis, large-molecule, biopharmaceuticals are produced in living organisms – such as animals or bacteria – and cannot be copied exactly.
  • Bio-better means a drug is in the same class as an existing biopharmaceutical but is not identical. While a biosimilar should perform as well as the original, a bio-better is expected to have certain advantages, such as improved safety and efficacy.
And unlike biosimilars, there’s no abbreviated regulatory route for bio-betters. But because they follow in the footsteps of a drug that has already been shown to be a therapeutic and commercial success, the risk of failure is expected to be lower than with most new drugs.

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