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Analyst Compiles List of Major Biosimilar ‘Knockoffs’

Companies wonder who’s next

Looking for all the major biosimilars in development? Look no further — biotech analyst Dr. Mark Schoenebaum of Evercore ISI has provided a comprehensive list to the BioSpace website.

On March 6, Novartis won approval for the nation’s first biosimilar after the FDA said that the company could sell its leukocyte drug Zarxio, a knockoff of Amgen’s blockbuster treatment Neupogen (filgrastim).

“Biosimilars will provide access to important therapies for patients who need them,” said FDA Commissioner Margaret Hamburg. “Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy, and quality standards.”

Biosimilars, which are made inside living cells, are always uniquely different in composition, which differentiates them from generic drugs, which are exact replicas of other drugs. Biosimilars have been widely available in Europe since 2006, but the FDA was granted the right to review and approve them only after the Patient Protection and Affordable Care Act was passed in 2010.

Now, as the industry braces for a change that is unprecedented since the advent of generic drugs, market watchers are scrambling to see which companies could have their own pipelines threatened by knockoffs — and how regulators might approach this thorny issue.

Schoenebaum compiled the following list of biosimilars currently in development:

Epogen (Epoetin Alfa) Biosimilars

  • Binocrit/HX575 (Sandoz) –– in phase III trials
  • Mircera (Roche) –– launched in E.U.
  • Unnamed (Hospira) –– filed in U.S.

Neulasta (Pegfilgrastim) Biosimilars

  • CHS-1701 (Coherus) –– in phase III trials
  • LA-EP2006 (Sandoz) –– in phase III trials
  • Lonquex (Teva) –– launched in E.U.
  • PF529 (Pfenex) –– in preclinical trials
  • Unnamed (Apotex) –– filed in U.S.
  • Unnamed (Mylan/Biocon) –– in preclinical trials

Neupogen (Filgastrim) Biosimilars

  • Granix (Teva) –– launched in E.U.
  • Unnamed (Apotex) –– filed in U.S.
  • Unnamed (Hospira/Celltrion) –– filed in U.S.

Source: BioSpace; April 3, 2015.

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