OR WAIT null SECS
June 02, 2015
Will biosimilars share a compendial identity like generic drugs do?
May 27, 2015
Eight physician groups wrote to the commissioner of FDA to stress the importance of transparency in biosimilar labeling to decrease prescribing risks.
May 22, 2015
As the biopharma industry awaits FDA’s guidance on biosimilar naming, brand and generic manufacturers establish positions.
May 12, 2015
The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.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
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
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.
April 28, 2015
FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.
April 23, 2015
Originator product manufacturers will have to update and improve their processing platforms to stay competitive with the biosimilars coming to market.