Pink Sheet 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

AbbVie Seeks Strict Interchangeability Standards For Biosimilars

This article was originally published in The Pink Sheet Daily

Executive Summary

Interchangeability must be demonstrated for every indication on reference product's label even if biosimilar is not approved for all the same uses, AbbVie says in citizen petition filed three weeks after Amgen submitted a 351(k) application referencing Humira.

You may also be interested in...



Biosimilar Litigation: Genentech Avastin Suit Tossed; Janssen Remicade Case Uncertain

US court dismisses Genentech suit over Amgen's patent dance moves; Janssen v. Celltrion trial is postponed as parties fight over Janssen's standing to sue; and Amgen wants to bar AbbVie citizen petition filers from seeing its Amjevita information.

Biosimilar Litigation: Genentech Avastin Suit Tossed; Janssen Remicade Case Uncertain

US court dismisses Genentech suit over Amgen's patent dance moves; Janssen v. Celltrion trial is postponed as parties fight over Janssen's standing to sue; and Amgen wants to bar AbbVie citizen petition filers from seeing its Amjevita information.

Biosimilar Labeling: Should FDA Just Throw Up Its Hands And Finalize Guidance?

Brand and generic industries are on opposite sides of spectrum on most issues; there is mutual opposition, however, to the use of a meaningless four-letter suffix in the proper name of a product.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS078116

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