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Big Pharma's Exit From Biosimilars May Be Imminent
Biosimilar developers are targeting blockbuster “Big Pharma” biologic originator companies. Roche and AbbVie, two companies most susceptible to biosimilar erosion, have vocalized a need for stringent regulatory frameworks — calling for appropriate data, individualized labels, and unique identification for all biotherapeutics — while attempting to rebuff competition by reformulating their products and beefing up both their pipelines and intellectual property (IP).
Scientist Invented A New Pathway To Approve Biosimilars, And The FDA Is Listening
In an extraordinary move, the FDA has withdrawn the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” after receiving public comments and one citizen petition (FDA-2018-P-1876). The goal of the guidance was to provide an action plan for evaluation of similarity between proposed biosimilars and the original products.
Biosimilar Regulatory Roundup: March 2019
March 2019 kicked off with a surprise, when FDA Commissioner Scott Gottlieb, MD, announced he was leaving the administration. In addition, the FDA released updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars; approved a Pfizer biosimilar; and more.
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