Manufacturing

Articles

Eight physician groups wrote to the commissioner of FDA to stress the importance of transparency in biosimilar labeling to decrease prescribing risks.

Physician Groups Band Together on Labeling of Biosimilars

The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.

FDA Releases Q&A on Biosimilars

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.

Court Blocks First FDA-Approved Biosimilar, for the Time Being

Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

Intellectual property lawyers estimate biosimilar litigation will swell as early as 2018.

Biosimilars Will Bring Significant Litigation and Patent Challenges

Stephen Wicks, PhD, is the scientific regulatory policy and intelligence officer of the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe, Stephen.WICKS@edqm.eu. EDQM is a leading organization that protects public health and amongst other things is responsible for the European Pharmacopoeia.

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.

Ensuring the Quality of Biologicals

FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.

FDA Releases Final Biosimilar Guidance

Originator product manufacturers will have to update and improve their processing platforms to stay competitive with the biosimilars coming to market.

Biosimilars May Spur Improvements in Reference Product Manufacturing Processes

In this article, industry experts discuss critical analyses for demonstrating biosimilarity.

An Orthogonal Approach to Biosimilarity

Biosimilar applicants will not be required to hand over their biosimilar applications and manufacturing dossiers to innovator companies, determines FDA.

FDA Denies Amgen's Certification Petition in Biosimilar Patent Dance

In a landmark decision, FDA approved Zarxio, making it the first biosimilar product in the United States.

Manufacturing, Biosimilars and Biobetters