In Vivo 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

The US Biosimilar Pathway: Unclear Just How Abbreviated, But Could Provide Useful Biosimilar 'Stamp'?

You may also be interested in...



Biosimilars: A New Kind Of Innovation

The lesson from first-generation biosimilars is that these aren't just small-molecule style copies. They require significant clinical and commercial support to overcome prescriber skepticism. For those lining up to tap into the next-generation opportunity, biosimilars represent a new kind of innovation, where the novelty lies in a drug's value-focused pricing, quality, cost-effective production, and in peripherals such as support-services and means of delivery. Although biosimilar market dynamics will vary from molecule to molecule, this emphasis on price and value rather than scientific breakthrough exemplifies a new definition of innovation in the biopharma sector.

Biosimilar User Fee Agreement Reached, But Will Require Appropriations Boost

Tentative agreement closely resembles FDA's original proposal.

Biosimilars Pathway Dilemma: When Should Sponsors Pick (k) Before (a)?

Extrapolation and interchangeability appear to be the linchpins for biosimilar sponsors mulling whether to send applications to the emerging 351(k) pathway or the traditional novel biologics approval system.

UsernamePublicRestriction

Register

ID017698

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