FDA Approves Kirsty as First Interchangeable Insulin Aspart Biosimilar

July 15, 2025

The FDA has approved Kirsty, the first interchangeable insulin aspart biosimilar, enhancing access to affordable diabetes care for millions.

White Paper Offers Tips for Sustaining Biosimilar Progress, Avoiding a Market Void

July 15, 2025

BioRationality: How the FDA Can Bypass Congress to Change Biosimilar Guidance

July 14, 2025

Balancing Cost Savings With Clinical Practice for Multiple Myeloma Biosimilars: Tyler Sandahl, PharmD

July 14, 2025

Inpatient Biosimilar Use Grows, Offering Cost-Saving Opportunities for Health Systems

July 11, 2025

Dr Colby Evans: The Managed Care Perspective on Biosimilars in Immunology

May 9th 2023

By Skylar Jeremias

Article

Colby Evans, MD, a dermatologist and co-author of an American Journal of Managed Care® supplement “Biosimilars for Immune-Mediated Inflammatory Diseases: 2022 Update" shares the managed care perspective on using biosimilars to treat inflammatory conditions.

RWE: Rituximab Biosimilar GP2013 Effective in Patients With RA After Switching From Originator

May 8th 2023

By Deana Ferreri, PhD

Article

In a study including 2 years of real-world evidence (RWE), patients with rheumatoid arthritis (RA) who were switched from originator rituximab (Rituxan) to GP2013, a rituximab biosimilar, experienced positive results and maintained clinical outcomes.

Dr Andre Harvin Answers How Oncologists Can Work to Expand Access to Biosimilars

May 7th 2023

By Skylar Jeremias

Video

Andre Harvin, PharmD, executive director of pharmacy and oncology services at Cone Health, explains how oncologists can work with other stakeholders to expand access to biosimilars and how patients can work with providers and biosimilar manufacturers to address financial challenges.

Long-term Phase 3 Results Show Similar Efficacy, Cardiac Safety of SB3 vs Herceptin

May 6th 2023

By Deana Ferreri, PhD

Article

The authors of what they say is the largest and longest follow-up study comparing the trastuzumab biosimilar SB3 to the reference product (Herceptin) in HER2-positive breast cancer found “no clinically meaningful difference” between the biosimilar and the reference product.

The Top 5 Biosimilar Articles for the Week of May 1

May 5th 2023

By Justina Petrullo

Video

Here are the top 5 biosimilar articles for the week of May 1, 2023.

Asembia: Payers More Likely to Prefer Multiple Biosimilars for the Same Reference Product

May 4th 2023

By Skylar Jeremias

Article

In a panel at the 2023 Asembia Specialty Pharmacy Summit, speakers presented on the payer perspective regarding biosimilars, including that they feel comfortable preferring multiple biosimilars for the same reference product and are looking for interchangeability designations.

Despite Concerns Over Extrapolation, Bevacizumab Biosimilars Are Widely Used in mCRC

May 3rd 2023

By Deana Ferreri, PhD

Article

A review article investigating the use of bevacizumab biosimilars found that despite lingering concerns about their usage for extrapolated indications, bevacizumab biosimilars are regularly used in metastatic colorectal cancer (mCRC) even though clinical tests only evaluate them in patients with lung cancer.

Samsung Bioepis Shares 1-Year Phase 3 Results for Eylea Biosimilar

May 2nd 2023

By Skylar Jeremias

Article

At the 2023 Association for Research in Vision and Ophthalmology Annual Meeting, Samsung Bioepis shared comparable safety, efficacy, and immunogenicity data through 1 year between its aflibercept biosimilar (SB15) and the originator (Eylea).

BioRationality: FDA Advice to Biosimilar Developers on Using PD Markers, Avoid Clinical Efficacy Testing

May 1st 2023

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, dives into how pharmacodynamic (PD) markers may be better than clinical efficacy testing for predicting whether a biosimilar is equally as safe and effective as its reference product, in his latest column.

Biosimilars Rheumatology Roundup for April 2023—Podcast Edition

April 30th 2023

By Skylar Jeremias

Podcast

On this episode of Not So Different, we recap some of the main news in April regarding biosimilars used to treat rheumatic conditions, including some progressions and some setbacks as well as research on nonmedical switching from originators to biosimilars.