Generic Drugs/Biosimilars

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.
Oct 29, 2015
By Pharmaceutical Technology Editors
USP responds to FDA's draft guidance on the naming of biological products.
Oct 27, 2015
Despite considerable investment by biotech manufacturers in developing competitive biologics for the US market, gaining FDA approval of these products has turned out to be a slow and complex process.
Oct 08, 2015
Data protection for biologics is reduced from 12 to five years as a result of the Trans-Pacific Partnership agreement.
Sep 28, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
The agency releases guidance on controlled correspondences related to generic-drug development.
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