Manufacturing, Biosimilars and Biobetters

EMA Adopts Biologics Pharmacovigilance Practices

August 15, 2016

The agency has adopted guidelines on the pharmacovigilance of biological drugs.

Celltrion Plans to Develop Tests to Determine ADA Levels in Blood

July 05, 2016

A study shows high levels of ADAs to infliximab at the beginning of treatment were associated with a poor response later on.

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.

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.

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.

FDA Releases Interim Response to AbbVie’s Citizen Petition

December 07, 2015

FDA released an interim response to AbbVie’s citizen petition on the labeling of biosimilars.

Final Rule on Labeling Changes Pushed Back to July 2016

December 04, 2015

PTSM: Pharmaceutical Technology Sourcing and Management

FDA sets a July 2016 deadline for the final version of the rule on labeling changes for approved drugs and biologics.