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How Biosimilars Are Approved and Litigated: Patent Dance Timeline

A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an FDA-approved reference biological product. Biosimilar applicants have a number of choices to make on the path...more

Introduction to Biologics and Biosimilars

Biologics are a fast-growing class of therapeutic compounds. In the United States, patent litigation between biologic manufacturers and biosimilar applicants occurs under the Biologics Price Competition and Innovation Act...more

Insulin and Other Biological Products Previously Regulated as “Drugs” Transition to Biologics Regulation on March 23, 2020

The market for insulin and certain other biological products may change in the coming months and years, as a provision in Biologics Price Competition and Innovation Act (BPCIA) goes into effect on March 23, 2020 changing how...more

Increasing Competition in the Biologic Market Through Truthful Advertising

This past week, FTC and FDA have taken further steps to encourage robust biosimilar competition in 2020 and beyond, this time with a particular focus on truthful and non-misleading advertising....more

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