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

UsernamePublicRestriction

FDA Publishes BsUFA III Commitment Letter Ahead Of 2022 Renewal

Biosimilar Supplement Review Goals Aim To Speed Approvals

Executive Summary

Following months of negotiations with industry and stakeholders, the FDA has released the commitment letter for the third iteration of its five-year Biosimilar User Fee Amendments program, marking another step ahead of its reauthorization.

You may also be interested in...



Biosimilars Forum Calls For Further Action On Biden’s Competition Order

Generics Bulletin sits down with Biosimilars Forum executive director Julie Reed to discuss preparing the HHS for Humira biosimilars, what more the agency could do for the industry and the Forum’s priorities over the next year.

US FDA Unlikely To Issue Broad Biosimilar Guidance Saying Comparative Clinical Studies Unnecessary

OTBB head Sarah Yim says FDA internal thinking is not aligned on the idea and that a lot of convincing was necessary to drop the clinical study requirement for insulin biosimilars.

Real-World Evidence Under Consideration For Use In Interchangeable Biosimilar Applications

US FDA research funded under BSUFA III will investigate what kind of safety data is needed for interchangeability. A demonstration project aimed at improving biosimilar product development efficiency and enhanced regulatory decision-making also will be part of the new regulatory science research program.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

GB151267

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