Generic Drugs

Alvotech Opens mAbs Biosimilar Facility in Iceland

June 10, 2016

Alvotech prepares for commercial biosimilar production in new facility with single-use bioreactors in Reykjavik, Iceland.

Biosimilars: Making the Switch Comes with Challenges

June 01, 2016

More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.

Biosimilars Council Says New Reimbursement Rules Will Hurt Competition in the Biosimilars Market

May 10, 2016

The GPhA and its Biosimilars Council expressed concern about the new proposed value-based reimbursement rules for Part B medications.

FDA Releases Annual Report on Generics

April 14, 2016

The Office of Generic Drugs highlights the agency’s work to advance generic drugs.

FDA Releases Online Course on Biosimilars

February 18, 2016

The course, intended for healthcare professionals, provides an overview of biosimilar products and FDA’s biosimilar product development programs.

Celltrion’s Biosimilar to Remicade Likely to be Approved for All Indications

February 09, 2016

There are no clinically meaningful differences between Celltrion’s CT-P13 and Remicade, according to an FDA briefing released ahead of the formal panel meeting.

Biosimilars Forum Launches Education Initiative

February 01, 2016

The Biosimilars Forum launched Partnership for Biosimilars Education and Access, an education initiative raising awareness of biosimilars in the US.

FDA Seeking Feedback on Generic Drug Recommendations

January 28, 2016

The agency is seeking industry input on product-specific recommendations to facilitate generic drug development.

NICE Announces Plans to Back Remicade Biosimilars

January 28, 2016

NICE announces plans to back biosimilar alternatives to Merck’s Remicade.

EMA Accepts Sandoz’s Biosimilar for Etanercept

December 08, 2015

Sandoz announces that the European Medicines Agency has accepted a MAA for a biosimilar of etanercept.