Skylar Jeremias

Boehringer Ingelheim Files Citizen Petition to Change FDA's BPCIA Interpretation

December 04, 2020

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).

Biosimilar Legal Roundup: November 2020

November 30, 2020

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.

Providers Exploit Minor Differences Between Innovator Drugs and Biosimilars

November 24, 2020

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.