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.

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.

Guidance on Biosimilar Licensure

February 06, 2020

FDA published draft guidance for applicants seeking licensure of a proposed biosimilar or proposed interchangeable biosimilar.

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.

Pharma’s Decade in Brief

January 02, 2020

As a new decade has begun, this editorial reviews some of the biggest, brightest, and boldest happenings from the industry over the past 10 years.

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.

Biosimilars Struggle to Establish in US Market

November 12, 2019

Developers of biosimilars have become dismayed with difficulties in gaining acceptance and reimbursement from the US healthcare system.