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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 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.
April 02, 2015
In this article, industry experts discuss critical analyses for demonstrating biosimilarity.
March 30, 2015
Biosimilar applicants will not be required to hand over their biosimilar applications and manufacturing dossiers to innovator companies, determines FDA.
March 06, 2015
In a landmark decision, FDA approved Zarxio, making it the first biosimilar product in the United States.
March 03, 2015
Biosimilars may add a nice increment to the pipeline opportunities, for CMOs, but they are unlikely to be a bonanza for the industry.
February 20, 2015
The Patent and Trademark Office sends notice rejection of the company’s Remicade patent.