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

Serono Rebif Blocked By Orphan Exclusivity, FDA Says, But Timing Is Unclear

Executive Summary

Serono has been informed by FDA that approval of its multiple sclerosis therapy Rebif is blocked by the orphan drug exclusivity of both Berlex' Betaseron and Biogen's Avonex, but has not been given a date for when that exclusivity will expire.

You may also be interested in...



Orphan Drug Status: Are Head-to-head Trials Needed To Show Superior Safety?

CSL Behring petitions FDA to revoke Wilate's orphan drug designation, but Octapharma counters that the effectiveness of its product's dual viral inactivation processes can be seen in post-market reporting.

Serono Rebif Approval Is First Orphan Drug Challenge Based On Efficacy

FDA's licensure of Serono's Rebif marks the first time the agency has overridden orphan drug exclusivity based on an efficacy endpoint, a March 7 1Office of Orphan Products Development memo outlining FDA's rationale for the approval states

Serono Rebif Approval Is First Orphan Drug Challenge Based On Efficacy

FDA's licensure of Serono's Rebif marks the first time the agency has overridden orphan drug exclusivity based on an efficacy endpoint, a March 7 1Office of Orphan Products Development memo outlining FDA's rationale for the approval states

Related Content

UsernamePublicRestriction

Register

ID005817

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