Biosimilars and Biobetters

July 01, 2020

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

May 05, 2020

FDA/FTC collaborate to end false and misleading statements and discuss the future of biosimilars at March 2020 public workshop on a competitive marketplace for biosimilars.

April 08, 2020

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

April 01, 2020

Demonstrating interchangeability can ensure biosimilar substitutability at the pharmacy level.

April 01, 2020

FDA is encouraging alternative insulins and challenging anticompetitive practices.

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.

February 06, 2020

FDA published draft guidance for applicants seeking licensure of a proposed biosimilar or proposed interchangeable biosimilar.

February 06, 2020

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

January 23, 2020

The FDA guidance provides an explanation of changes to user fees under the Biosimilar User Fee Amendments of 2017 under Title IV of the FDA Reauthorization Act of 2017.

November 20, 2019

The agency’s approval of Abrilada (adalimumab-afzb), a biosimilar to Humira, brings the total of approved biosimilars to 25.