Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Best Pathway To Interchangeable Insulins Is In The Eye Of The Beholder

Executive Summary

Approaches suggested at a US FDA public hearing include allowing follow-on insulins to take a direct route to interchangeability without first having to be approved as biosimilars, and automatically declaring biosimilar insulins interchangeable with one or more reference products.

You may also be interested in...



FDA Publishes Immunogenicity Guidelines For Biosimilar Insulins

In a move that will likely be welcomed by industry, the US FDA has issued draft guidance stating that sponsors will generally not need to conduct comparative clinical immunogenicity studies in developing biosimilar/interchangeable products.

Biosimilar Insulins (Generally) Won't Need Comparative Clinical Immunogenicity Data, US FDA Says

In a move that will likely be welcomed by industry, the US FDA issued draft guidance stating that sponsors will generally not need to conduct comparative clinical immunogenicity studies in developing biosimilar/interchangeable products.

US FDA Will Allow Transitioning Products To Continue Referencing Drug Master Files

The 'technical detail' needed to be resolved in part to ensure there would be no shortages after the 2020 change from regulation as drugs to biologics for certain protein products, the agency said.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS125288

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel