Generic Drugs/Biosimilars

May 12, 2015
By Pharmaceutical Technology Editors
The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.
May 07, 2015
The US Court of Appeals granted Amgen’s request to block Novartis’ Neupogen biosimilar, Zarxio, from the US market until the court resolves litigation between the two companies.
May 06, 2015
By Pharmaceutical Technology Editors
Eleven of the leading US biosimilar developers have collaborated to form the Biosimilars Forum, a nonprofit organization formed to expand patient access to biosimilars.
May 04, 2015
Intellectual property lawyers estimate biosimilar litigation will swell as early as 2018.
May 02, 2015
Pharmaceutical Technology
The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.
Apr 28, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.
Apr 23, 2015
Originator product manufacturers will have to update and improve their processing platforms to stay competitive with the biosimilars coming to market.
Apr 02, 2015
Pharmaceutical Technology
FDA approves a biosimilar and loses a commissioner in March.
Apr 02, 2015
Pharmaceutical Technology
In this article, industry experts discuss critical analyses for demonstrating biosimilarity.
Mar 30, 2015
Biosimilar applicants will not be required to hand over their biosimilar applications and manufacturing dossiers to innovator companies, determines FDA.
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