Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

FDA Draft Guidance on Biosimilar Interchangeability Sets High Standard

XTALKS VITALS NEWS

FDA

According to the regulatory agency, biosimilars will need to demonstrate the same clinical results as branded biologics for all approved indications, in order to be considered interchangeable.

Share this!

January 20, 2017 | by Sarah Hand, M.Sc.

The US Food and Drug Administration (FDA) has released some much-anticipated draft guidance on biosimilar interchangeability with its reference product. According to the regulatory agency, biosimilars will need to demonstrate the same clinical results as branded biologics for all approved indications, in order to be considered interchangeable.

This new regulatory framework sets the bar high for makers of biosimilars. In the US, only four biosimilars have been approved to-date, none of which are considered to be interchangeable with their reference product.



Right now, biosimilars need to demonstrate a high degree of similarity to its branded biologic counterpart in order to gain FDA approval. Drugmakers must show that the safety, purity and potency of a biosimilar match that of its reference product.

Unlike generic drugs however, biosimilars are not chemically identical to biologics, which is the reason why prescribers and pharmacists are unable to automatically substitute one for the other. To achieve interchangeable status, drugmakers will have to conduct trials aimed at determining whether switching from a biologic to a biosimilar poses any risk to the patient.

According to the guidance, post-marketing studies for already-approved biologics will not be sufficient to support an application for interchangeability. The FDA will be accepting comments on their draft guidance until March 20, 2017, at which time they will begin to compose their final guidance.

Sandoz’s biosimilar of Amgen's Neupogen (filgrastim) became the first biosimilar to be approved in the US in 2015. Since then, Sandoz has been granted another biosimilar approval, joining Hospira and Amgen’ approved biosimilars.


Keywords: Biosimilar, Biologic, FDA


| NEXT ARTICLE | MORE NEWS | BLOGS | VIDEOS | POLLS & QUIZZES | WEBINARS |

Share this with your colleagues!

MORE NEWS
Small Molecule May Disrupt Biofilm Formation on Implantable Medical Devices

March 28, 2017 - Researchers at Trinity College Dublin in Ireland have identified a small molecule capable of preventing bacterial biofilms from growing on medical implants.

Featured In: Medical Device News


FDA Approves PD-L1 Immunotherapy Developed by Pfizer and Merck KGaA

March 27, 2017 - Pfizer and Merck KGaA’s PD-L1 inhibitor, Bavencio (avelumab), has become the first immunotherapy to be approved by the US Food and Drug Administration (FDA) to treat a rare form of skin cancer, known as metastatic Merkel cell carcinoma (MCC).

Featured In: Biotech News


New Approach Could Allow Red Blood Cells to be Manufactured

March 27, 2017 - UK researchers at the University of Bristol have developed an immortal line of early adult erythroblasts capable of continuously producing mature red blood cells.

Featured In: Biotech News

LEAVE A COMMENT
 
  
THE XTALKS VITALS LIFE SCIENCE BLOG

Will Pharmaceutical Serialization Solve All of Our Drug Counterfeiting Problems?

REGISTER FOR THESE WEBINARS

Strategies for Deploying Innovative Solutions for Perimeter Security


High Performance Computing for High Content Screening - A Case Study


The FDA Guidance on the Assessment of Abuse Potential of Drug – A Critical Review


Treatment of Psoriasis: Improvements Through Clinical Trials


Copyright © 2016-2017 Honeycomb Worldwide Inc.