This notice establishes a public docket seeking comments from interested parties on determining whether biosimilar product development would be best served by focusing on product class-specific guidance documents that address common development issues that apply to a broad class of products (eg, monoclonal antibodies), or by developing product-specific guidance documents (eg, adalimumab products).
As part of the Biosimilar User Fee Amendment (BsUFA III program, the FDA has updated its biosimilar action plan and is revisiting how best to advance the development of new biosimilar products. FDA guidance can enhance scientific and regulatory clarity for the biosimilar product development community and represents the agency’s current thinking on a matter.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Stealth Biotherapeutics is an American biotech with a focus on mitochondrial therapies, in fields as diverse as metabolics, neurology and musculoskeletal.
FDA seeks comments on specific guidances for biosimilars
The US Food and Drug Administration (FDA) has issued a Federal Register notice, “Biosimilar Product Development Guidance; Establishment of a Public Docket; Request for Information and Comments.”
This notice establishes a public docket seeking comments from interested parties on determining whether biosimilar product development would be best served by focusing on product class-specific guidance documents that address common development issues that apply to a broad class of products (eg, monoclonal antibodies), or by developing product-specific guidance documents (eg, adalimumab products).
As part of the Biosimilar User Fee Amendment (BsUFA III program, the FDA has updated its biosimilar action plan and is revisiting how best to advance the development of new biosimilar products. FDA guidance can enhance scientific and regulatory clarity for the biosimilar product development community and represents the agency’s current thinking on a matter.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
Free
7 day trial access
Become a subscriber
£820
Or £77 per month
Chairman, Sanofi Aventis UK
More on this story...
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
More Features in Biosimilars
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze