Generics Bulletin 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


US FDA Outlines Biosimilar First Interchangeability Policy … In A Memo

Executive Summary

Stakeholders may be irked that the agency chose to release a memo on its interpretation of the first interchangeable exclusivity law before issuing formal guidance.

You may also be interested in...

Biosimilar Interchangeable Exclusivity Guidance Still Planned Despite Memo Release, US FDA Says

While many interpretations of the law protecting the first interchangeable biosimilar approved for a reference product are included in a recently released FDA memo, the agency says it has a limited scope.

Interchangeable Exclusivity: Pfizer To Rival Boehringer On Humira Biosimilar After US FDA Decision

FDA decision ends Boehringer Ingelheim’s exclusivity for interchangeable biosimilar of Humira after just a few months. Pfizer reveals pricing and launch information for its Abrilada version of adalimumab.

FDA Decision On Interchangeable Exclusivity Allows Pfizer To Rival Boehringer On Adalimumab

An FDA decision around the timing of first interchangeable biosimilar exclusivity has brought to an end Boehringer Ingelheim’s time on the market with a unique interchangeable Humira rival, with the agency also granting interchangeability for Pfizer’s Abrilada version of adalimumab.

Related Content


Related Companies

Latest Headlines
See All



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