Diabetes

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.

Analyst: China Leads APAC Region for Biosimilar Development, Marketing

September 7th 2021

By Tony Hagen

Article

Shanghai Henlius Biotech, Innovent Biologics, and other Chinese biopharmaceutical makers are leading the wave of Asia-Pacific (APAC) biosimilar development, according to a GlobalData analyst.

Opinion: The Debate Over Animal Toxicology Studies

September 4th 2021

By Sarfaraz K. Niazi, PhD

Article

Animal toxicology studies still get included with biosimilar approval applications, although there are strong arguments that most of these studies are unnecessary. Sarfaraz K. Niazi, PhD, explains the pros and cons.

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.

Study: Biosimilar rhGH Well Tolerated and Effective in Turner Syndrome

August 23rd 2021

By Deana Ferreri, PhD

Article

A multicenter study of recombinant human growth hormone (rhGH) in children with Turner syndrome demonstrated safety and efficacy comparable to the reference product.

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.