Gastroenterology

Remsima Delivers Positive Results in IBD Switching Study

October 4th 2021

By Tony Hagen

Studies of the infliximab biosimilar Remsima in patients with inflammatory bowel disease were presented at United European Gastroenterology Week 2021.

September Roundup: Biosimilar Policy Recommendations, Clinical Developments, and Interviews

September 27th 2021

The month of September 2021 was chock-full of biosimilar news. From regulatory actions to policy initiatives to clinical news, no dust was gathering on the road toward wider biosimilar adoption.

Amgen Estimates $9.8 Billion in Cumulative US Biosimilar Savings

September 22nd 2021

By Tony Hagen

In a biosimilar trend report, Amgen discusses marketing achievements, US biosimilar policy, payer and provider acceptance of these agents, and the outlook for further growth.

FDA Delays Review of Alvotech's AVT02 Adalimumab Biosimilar Candidate

September 21st 2021

By Tony Hagen

Reykjavik, Iceland company Alvotech said the FDA review of its adalimumab candidate is held up by pandemic-related curbs on overseas inspections.

Opinion: FDA Changes to Biosimilar Development Guideline Save Money and Time

September 11th 2021

By Sarfaraz K. Niazi, PhD

Refinements to the analytical testing of biosimilar candidates to verify similarity were worked into 2019 guidance from the FDA. These changes offer what the author considers a more "rational approach."

Alvotech Reports Positive Switching Results for AVT02 Adalimumab Candidate

September 9th 2021

By Tony Hagen

The findings support Alvotech's bid for interchangeable status for the high-concentration, citrate-free adalimumab biosimilar candidate.

Strength of Patent Protection Varies by Patent Type

September 9th 2021

By Tony Hagen

The strength of a patent wall built up around an originator biologic depends on the quality of patents that make it up and the originator company's willingness to engage in costly litigation. Part 2 of a series.

BIO Attorneys Address Patent Thicket Misconceptions

September 8th 2021

By Tony Hagen

In this first part of a series, intellectual property attorneys from the Biotechnology Innovation Organization (BIO) contend that originator patents are not the formidable obstacles to biosimilars they are made out to be.

Report: Physician-Patient Education Can Improve Biosimilar Acceptance

August 31st 2021

By Tony Hagen

Misperceptions of biosimilars contribute to low acceptance of these products. Two Cardinal Health researchers discuss barriers to understanding and the importance of biosimilar education.

Opinion: How to Get FDA Clinical Efficacy Testing Waivers for Biosimilars

August 28th 2021

By Sarfaraz K. Niazi, PhD

Clinical efficacy studies are not always required for biosimilars, and it's possible to resist if the FDA does ask for them. Sarfaraz K. Niazi, PhD, suggests a game plan.