Biosimilarity, yes. Interchangability, no.

  • by: |
  • 04/29/2015

FDA has released three final guidance documents on biosimilars but left for later its regulatory answers on requirements for demonstrating interchangeability of a biosimilar with a reference product and terms for establishing the exclusivity period for pioneer biologics. 
FDA will address these issues in a separate draft guidance. The agency does not have an estimated timeline for when the document will be released.

The agency released final guidances covering scientific and quality considerations in demonstrating biosimilarity. The document on scientific considerations includes additional information on study design, endpoint selection and appropriate patient populations for a comparative clinical trial. 
The guidance also clarifies what factors to consider when assessing whether products are highly similar, including expression system, manufacturing process, impurities, reference product and reference standards.

The agency also issued a guidance providing questions and answers on biosimilars, which explain how sponsors can justify extrapolation from a single indication to support approval for additional indications on a reference product's label. The document indicates that sponsors should avoid extrapolation from indications for which the reference product has obtained accelerated approval but has not yet demonstrated clinical benefit in post-marketing trials. 

The Q&A also includes FDA's expectations for the submission of pediatric study plans and outlines justification that should be provided by a sponsor to use comparative data with a non-U.S.-licensed product to support an application to FDA.



Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

Blog Roll

Alliance for Patient Access Alternative Health Practice
Better Health
Biotech Blog
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
Envisioning 2.0
FDA Law Blog
Fierce Pharma
Fresh Air Fund
Furious Seasons
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
In the Pipeline
In Vivo
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
More than Medicine
National Review
Neuroethics & Law
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmacology Corner
Pharmaceutical Business Review
Piper Report
Prescription for a Cure
Public Plan Facts
Real Clear Politics
Shark Report
Shearlings Got Plowed
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog