Biosimilars and Biobetters

EC Approves Celltrion Healthcare’s Adalimumab Biosimilar

February 17, 2021

The EC has granted marketing authorization to Celltrion Healthcare for its adalimumab biosimilar, Yuflyma (CT-P17).

Cadila Pharmaceuticals Launches Biosimilar Rituximab

August 13, 2020

The company has launched its biosimilar rituximab, Ritucad, for the Indian market.

Henlius and Accord Healthcare Receive European Approval for Biosimilar Trastuzumab

August 13, 2020

The companies received approval from the EC for Zercepac (HLX02), a biosimilar referencing Roche’s originator biologic, Herceptin (trastuzumab).

CHMP Gives Positive Opinion on Centus Biotherapeutics’ Bevacizumab Biosimilar

August 13, 2020

The committee has given a positive opinion on the biosimilar bevacizumab for several cancer indications.

Using Analytical Assays to Ensure Biosimilar Quality

August 05, 2020

The use of analytical assays is crucial for determining that biosimilar critical quality attributes remain on point.

Pharmaceutical Technology Europe

Analytical Assays Determine Biosimilar Product Quality

July 01, 2020

Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.

The Design Driver for Biosimilar Adoption

April 08, 2020

Industry opportunities are increasing for biosimilars, but companies should pay close attention to delivery device design to facilitate success.

Biosimilars Poised for Gains in US Market

April 02, 2020

FDA is encouraging alternative insulins and challenging anticompetitive practices.

FDA Smooths Transition of Biologic Approvals

February 21, 2020

As the date for transitioning the approval of biologic drug to a new pathway comes closer, FDA publishes a final rule and answers questions on the pathway changes.

FDA and FTC Collaborate on Competitive Biologics Market

February 06, 2020

The two agencies are collaborating to support a robust biologics marketplace by taking steps to deter anti-competitive business practices.