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

Latin America: How Regulatory Transparency Can Tackle Non-Comparable Biologics

Executive Summary

Non-comparable biologics are a common problem in Latin America as they could deter companies with true biosimilars from entering the market. Among the solutions are better regulatory transparency and action to deal with “non-comparables” already on the market, says FIFARMA, the Latin American Federation of Pharmaceutical Industry.

You may also be interested in...



Global Template for Sharing Biosimilar Assessment Data Suggested By Regulators Group

Proposal suggests condensing key data and findings into under 10 pages, published in English.

Lack Of Industry Involvement In EU HTA Scoping Process Exacerbates ‘Unworkable’ Timelines

Scientific advice could help companies make up for the lack of involvement in scoping, but slots are in short supply.

German HTA Queries Polivy Benefits Amid Lack Of Evidence

Roche’s lymphoma drug Polivy could face pricing challenges in Germany as it undergoes a full benefit assessment.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS119683

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