Generic Drugs/Biosimilars

Apr 14, 2016
By Pharmaceutical Technology Editors
The Office of Generic Drugs highlights the agency’s work to advance generic drugs.
Feb 18, 2016
By Pharmaceutical Technology Editors
The course, intended for healthcare professionals, provides an overview of biosimilar products and FDA’s biosimilar product development programs.
Feb 09, 2016
There are no clinically meaningful differences between Celltrion’s CT-P13 and Remicade, according to an FDA briefing released ahead of the formal panel meeting.
Feb 01, 2016
By Pharmaceutical Technology Editors
The Biosimilars Forum launched Partnership for Biosimilars Education and Access, an education initiative raising awareness of biosimilars in the US.
Jan 28, 2016
By Pharmaceutical Technology Editors
NICE announces plans to back biosimilar alternatives to Merck’s Remicade.
Jan 28, 2016
By Pharmaceutical Technology Editors
The agency is seeking industry input on product-specific recommendations to facilitate generic drug development.
Dec 08, 2015
By Pharmaceutical Technology Editors
Sandoz announces that the European Medicines Agency has accepted a MAA for a biosimilar of etanercept.
Nov 30, 2015
FDA should not release naming rules for biosimilars ahead of interchangeability guidelines, says the pharmacy benefit manager.
Nov 24, 2015
Text from a merger prospectus reveals the termination fee for the proposed Pfizer-Allergan deal would change if any new tax regulations were passed prior to the closing of the transaction.
Nov 06, 2015
Even though rising production and use of generic pharmaceuticals is saving billions for the nation’s healthcare system, policy makers continue to slap the industry with policies it claims will limit product development and sales.
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