Gastroenterology

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

Article

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

Article

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

Article

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

Article

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.

CVS Juggles Biosimilar Options on Its Formulary

August 26th 2021

By Tony Hagen

Article

CVS Caremark has reordered its list of preferred therapeutics, adjusting the emphasis on biosimilars, and demonstrating that preferential status can change at any time.

Opinion: A Modified 351(a) Licensing Pathway for Biosimilars

August 21st 2021

By Sarfaraz K. Niazi, PhD

Article

Use of the 351(k) biosimilar approval pathway entails legal challenges, high costs, and potentially higher clinical evidence standards. Sarfaraz K. Niazi, PhD, suggests that using the 351(a) pathway for standalone drugs and copy products may be faster and better. This is part 3 of a series.

Rumors of HHS Biosimilars Coding Change Spark Concerns

August 20th 2021

By Tony Hagen

Article

Worries about what HHS will propose in its anticipated biologics pricing reform policy have been exacerbated by a rumored coding change.

Advocacy Groups Call for Zero Co-pay Policy on Biosimilars

August 20th 2021

By Tony Hagen

Article

A group of 16 advocacy groups are urging HHS to make zero co-pays for biologics a part of its prescription drug price reform program.

Biden Asks Congress for Support on Pharmaceutical Price Controls

August 13th 2021

By Tony Hagen

Article

Passage of HR 3 is shaping up as a centerpiece of President Biden's effort to bring pharmaceutical prices under control. If drug companies won't negotiate prices, international reference pricing would kick in.