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

Biosimilar “Interchangeability” Standard Is Double-Edged Sword For Generics

Executive Summary

The interchangeability standard for follow-on biologics set out in Senate legislation creates a relatively smooth pathway for generic firms to seek approval of such products, but could also lead to an extended struggle to win acceptance for such products in the marketplace

You may also be interested in...



Senate Follow-On Biologics Bill Still Stuck In Evergreen Forest

Despite moving a bill out of committee last session, the Senate is still wrangling over the issue of whether modifications of existing products should get full exclusivity.

Senate Biosimilars Bill Readied For Take-Off In Next Congress

Kennedy will enter 111th Congress with a ready-to-go bill after committee officially reports out S. 1695 last week.

Biosimilars Pathway Seen As Part Of Health Care Reform Debate Next Year

The potential for cost savings from biosimilars is likely to entangle the debate over a pathway for their approval into the discussion on health care reform that will unfold in the next Congress

Related Content

UsernamePublicRestriction

Register

PS048512

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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