Generic Drugs/Biosimilars

Jun 09, 2015
By Pharmaceutical Technology Editors
The product, marketed as Sirdupla in the United Kingdom, is the generic version of GSK’s beta agonist and corticosteroid combination treatment for asthma.
Jun 08, 2015
In a Citizen Petition to FDA, AbbVie calls the current biosimilar labeling practices “legally unsound.”
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 27, 2015
Widespread use and abuse of opioid painkillers is prompting efforts to develop new drugs and formulations that resist abuse while providing relief to legitimate patients.
May 22, 2015
As the biopharma industry awaits FDA’s guidance on biosimilar naming, brand and generic manufacturers establish positions.
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The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.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.
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