US guidelines for biosimilars

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Last update: 25 October 2019

The regulatory body for approval of medicines in the US is the Food and Drug Administration (FDA).


Currently, the legal pathway in the US for the approval of biosimilars is the Biologics Price Competition and Innovation Act (BPCI Act) of 2009.

The BPCI Act is part of the healthcare reform legislation, which was signed into law on 23 March 2010 by President Barack Obama. The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated to be ‘highly similar’ (biosimilar) to, or ‘interchangeable’ with, an FDA-approved biological product.

FDA is still in the process of developing guidelines regarding biosimilars.

In order to implement the BPCI Act, FDA has already set up the Biosimilar Implementation Committee, co-chaired by Dr Janet Woodcock, Director of the Center for Drug Research and Evaluation (CDER) and Dr Karen Midthun, Acting Director of the Center for Biologics Evaluation and Research (CBER). In addition to this, the agency has in place two review committees; the CDER Biosimilar Review Committee which will be chaired by Dr John Jenkins and the CBER Biosimilar Review Committee which will be chaired by Dr Robert Yetter.

The agency also held a 2-day public meeting on 2 and 3 November 2010 to gain input on the act’s implementation from interested parties, including the public, healthcare professionals and manufacturers.

The FDA has the following guidelines regarding biosimilars:

1.  Overarching Guidelines
These guidelines cover all biosimilar products:

Scientific considerations in demonstrating biosimilarity to a reference product
Date: April 2015

Quality considerations in demonstrating biosimilarity to a reference protein product
Date: April 2015

Clinical pharmacology data to support a demonstration of biosimilarity to a reference product
Date: December 2016

2. Other Guidelines
Other guidelines relevant for biosimilars from the FDA include:

Biosimilars: questions and answers
Date: April 2015

Formal meetings between FDA and biosimilar sponsors
Date: November 2015 

Nonproprietary naming of biological products
Date: January 2017

Best Practices for communication between IND sponsors and FDA during drug development (includes biosimilar development)
Date: December 2017

Questions and answers on biosimilar development and the BPCI Act
Date: December 2018

Interpretation of the “Deemed to be a License” provision of the BPCI Act of 2009
Date: December 2018

Considerations in demonstrating interchangeability with a reference product
Date: May 2019

3. Draft Other Guidelines
The FDA has issued draft guidance documents for public comment. Instructions on how to submit comments is announced in a Federal Register notice.

Reference product exclusivity
Date: August 2014

Biosimilars: additional questions and answers
Date: May 2015

Labelling for biosimilar products
Date: March 2016

Implementation of the ‘Deemed to be a License’ provision of the BPCI Act
Date: March 2016

New and revised draft Q&As on biosimilar development and the BPCI Act (Revision 2)
Date: December 2018

The “Deemed to be a License” provision of the BPCI Act Q&As
Date: December 2018

Development of therapeutic protein biosimilars: Comparative analytical assessment and other quality-related considerations
Date: May 2019

4. Rules
The FDA has also issued rules. These rules cover issues related to biosimilar products:

Definition of the term “biological product”
Date: December 2018

Related articles
FDA holds public hearing on biosimilars pathway

US healthcare reform

The biosimilars challenge

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Source: US FDA

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