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December 04, 2020
Article
To spur more biosimilar development and reduce anticompetitive practices, the company argued the FDA could improve its interpretation of the term “strength” in the Biologics Price Competition and Innovation Act (BPCIA).
December 02, 2020
Article
The FDA clarified a number of concerns surrounding the appropriate procedures for industry to apply for interchangeability status.
November 30, 2020
Article
In November, the Supreme Court heard arguments on the Affordable Care Act, Europe fired up its efforts to create a more biosimilar-friendly environment, and Genentech fought to protect its bevacizumab franchise.
November 24, 2020
Article
Minute differences between biosimilars and reference products are not considered “clinically meaningful,” but these differences are exploitable when it comes to addressing allergies related to originator products.