Generic Drugs

An Orthogonal Approach to Biosimilarity

April 02, 2015

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

Welcome to the Biosimilar Era

April 02, 2015

FDA approves a biosimilar and loses a commissioner in March.

Industry Responds to FDA Labeling Rule

March 30, 2015

Drug makers back alternative to FDA labeling update rule.

FDA Denies Amgen's Certification Petition in Biosimilar Patent Dance

March 30, 2015

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

BIO Encourages Transparency with Support of Biologic Interchangeability Bill

March 13, 2015

BIO and the Colorado BioScience Association urge Colorado Governor Hickenlooper to sign a bill that will help patients gain access to interchangeable biologic products following FDA approvals.

FDA Approves First Biosimilar

March 06, 2015

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

Modest Expectations for CMOs and Biosimilars

March 03, 2015

PTSM: Pharmaceutical Technology Sourcing and Management

Biosimilars may add a nice increment to the pipeline opportunities, for CMOs, but they are unlikely to be a bonanza for the industry.