FDA releases three biosimilars guidances

April 29, 2015 8:03 AM

The U.S. FDA finalized and published three new guidances which clarifies what’s needed to submit so-called 351(k) applications to the agency in order to gain new approvals.

Although companies are eagerly awaiting the guidance on interchangeability and also closely following the discussions on non-proprietary names for biosimilars, there are no definite timelines for those releases yet.

Before those guidances about interchangeability and non-prorietary names, the FDA has recently approved it’s first biosimilar (Zarxio – filgrastim) and a couple of submissions including the first monoclonal antibody biosimilar, Hospira/Celltrion’s infliximab, are still ongoing at the agency.

The new final guidances, which were delivered yesterday, on 28 April, finally closes some of the ongoing draft guidance procedures at FDA since February 2012.

The first document, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is biosimilar to a reference product for purposes of the submission of a marketing application under section 351(k) of the Public Health Service Act. This new guidance gives an overview of FDA’s approach to determining biosimilarity and discusses important scientific considerations in demonstrating biosimilarity.

The FDA’s other two documents are Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product and Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.

The first guidance about Quality Considerations provides guidance on analytical studies that are relevant to assessing whether the proposed product and a reference product are highly similar to support a demonstration of biosimilarity. FDA again emphasizes that, this document is not intended to provide an overview of FDA’s approach to determining interchangeability, which will be addressed in a separate guidance document.

And the final guidance gives answers to common questions like:
– Whom should a sponsor contact with questions about its proposed biosimilar development program?
– Can a proposed biosimilar product have a different formulation than the reference product?
– Can an applicant obtain licensure of a proposed biosimilar product for fewer than all routes of administration for which an injectable reference product is licensed?

Source: FDA

Leave a Reply

Twitter ID
(ID only. No links or "@" symbols)


Share an Article?

Writing an article is not only a great way to share your knowledge, but it is also a great way to give back to the community.

We value all our contributors and if you have a website, we will surely give a link back to your site and products.
Wanna contribute?


Biosimilar News was started for the people who are interested in this rapidly growing business area. So if you have suggestions or feedback on how we can improve, please let us know. If you want to see a specific topic covered, answer to a specific question, or anything else of this sort, just write us. We do our best to keep up!
Make a suggestion now!