Biosimilars and Biobetters

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.

Commentary: A Competitive Marketplace for Biosimilars

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.

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 Tackle Interchangeability Standards

April 01, 2020

Demonstrating interchangeability can ensure biosimilar substitutability at the pharmacy level.

Biosimilars Poised for Gains in US Market

April 01, 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.

Guidance on Biosimilar Licensure

February 06, 2020

FDA published draft guidance for applicants seeking licensure of a proposed biosimilar or proposed interchangeable biosimilar.

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.

Guidance Explains User Fee Structure for Biosimilars

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.

FDA Advances Biosimilar Approvals

November 20, 2019

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