Biosimilar News Bytes to Wrap up 2016

A Shrug of the Shoulders on Savings Payers are becoming increasingly pessimistic that they will be seeing substantial savings with biosimilar products in the near term. The results of several market research projects we’ve conducted point to payers’ assumption that the 15% discounts seen today with Inflectra® and Zarxio® introductions will be mimicked by manufacturers of new biosimilar and follow-on products (assuming they cross the FDA approval and patent litigation barrier). Risking these introductions, the payers assume that makers of the originator products will simply match the offer, enabling the payer to take the path of least resistance and stick with the originator. But this means that the predicted tens of billions in savings to be gained by the biosimilar introductions will remain a mirage, at least until several competitors enter the market for the same originator.

Trastuzumab Biosimilar Data Published The Mylan and Momenta partnership announced that the phase 3 trial data on its biosimilar version of trastuzumab, previously announced at major medical meetings this year, has been published in the Journal of the American Medical Association. The HERITAGE study confirmed the safety and efficacy of MYL-1401O.

Final Guidance Released by FDA The Food and Drug Administration finalized and released its guidance “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product,” which describes how biosimilar products may be listed as “not similar,” “similar,” “highly similar,” and “highly similar with fingerprint-like similarity.” The latter, it is assumed, will be used as a basis for considering interchangeability designations. The guidance is a belated tool to assist drug makers with proving pharmacologically the similarity of their molecule to the originator.

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