Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Changes To EU Orphan Similarity Concept Could Change Innovation Threshold For 10-Year Exclusivity

Executive Summary

The European Commission has proposed changes to the existing criteria used for determining whether a new medicinal product is similar to an already authorized orphan drug and, therefore, whether it can be accepted for evaluation and granted 10-year market exclusivity.

You may also be interested in...



EU Updates Definition Of ‘Similarity’ For Orphans In View Of Advances In Gene And Cell Therapies

Practical advice has also been issued on how the concept of similarity should be applied to advanced therapy medicinal products.

Pharma Welcomes Clarity On Similarity Assessment Of ATMPs Under EU Orphan Law

As the European Commission reviews the concept of similarity within the context of EU orphan drugs legislation, it has introduced a new section on advanced therapy medicinal products to clarify how similarity assessments should be carried out for such products. While the industry has welcomed this new guidance, it urges caution on this front as R&D in this field is still evolving.

New Guidance Brings Welcome Clarity on Practical Application of EU Orphan Drugs Law

EU pharmaceutical companies have welcomed new European Commission guidance that provides greater clarity on how several key provisions of the legislation on orphan drugs should be applied in practice.

Related Content

Topics

UsernamePublicRestriction

Register

LL1134044

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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