News | December 4, 2020

Boehringer Ingelheim Submits Citizen Petition To FDA Concerning Interpretation Of ‘Strength' In Biologics Price Competition And Innovation Act

Boehringer Ingelheim has filed a Citizen Petition asking the Food and Drug Administration (FDA) to correct its interpretation of the term “strength” as used in the Biologics Price Competition and Innovation Act (“BPCIA”). We believe the actions requested in this petition will benefit patients and the healthcare system, potentially leading to more robust biosimilar development and use, and reduce anti-competitive behavior within the biosimilars industry.

FDA’s current interpretation of “strength” does not allow a biological product to be licensed as a biosimilar and/or interchangeable product if there is any variation in inactive drug volume, even if it has the exact same amount of active drug content as the reference product.

By working closely with industry peers, payors, healthcare providers, and patient advocates, and engaging in a transparent and public discussion of the issues we have raised, Boehringer Ingelheim believes that correction of the interpretation by the FDA may increase access to more affordable biosimilar and interchangeable biological products approved via the 351(k) pathway.

We are proud of the role we play in raising public awareness of biosimilars as well as the importance of stimulating a competitive marketplace to bring more affordable treatment options to U.S. patients. Please click here ( to read the complete Citizen Petition and learn how to submit a comment to the FDA.

For more information about Boehringer Ingelheim’s biosimilar, please click here:   

About Boehringer Ingelheim
Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing.

We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation and is part of the Boehringer Ingelheim group of companies.  In addition, there are Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont, Inc. in Fremont, CA.

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Source: Boehringer Ingelheim