Two More Pairs of Denosumab Biosimilars Enter US Market

How can we achieve a long-term sustainable biosimilars market?

October 11th 2023

Biosimilars Check-In: BI Launches Unbranded Adalimumab; New Omalizumab Deal; CRL for Insulin Aspart

October 10th 2023

By Skylar Jeremias

Boehringer Ingelheim (BI) launches an unbranded version of its adalimumab biosimilar; Alvotech and Kashiv Biosciences partner for an omalizumab biosimilar candidate; the FDA issues a complete response letter (CRL) for Biocon’s insulin aspart biosimilar.

Samsung Bioepis Presents Positive Phase 3 Data on Aflibercept Candidate

October 9th 2023

By Skylar Jeremias

At EURETINA 2023, Samsung Bioepis shared positive comparative efficacy data on its aflibercept biosimilar candidate, demonstrating that the product is as safe and effective as the originator (Eylea).

Dr Stephen Hanauer Welcomes Adalimumab Biosimilars to the Gastroenterology Space

October 8th 2023

By Skylar Jeremias

Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, explained the initial experience gastroenterologists have had with anti–tumor necrosis factor biosimilars and how new adalimumab biosimilars will impact the space.

The Promise of Biosimilars Is Within Reach for Health Systems

October 7th 2023

By Jim Lichauer, PharmD, BCPS, FASHP

A collaborative exercise with 16 health care organizations nets millions in savings.

The Top 5 Biosimilar Articles for the Week of October 2

October 6th 2023

By Justina Petrullo

Here are the top 5 biosimilar articles for the week of October 2, 2023.

Abrilada Approved as Second Interchangeable Humira Biosimilar

October 5th 2023

By Skylar Jeremias

Pfizer’s Abrilada (adalimumab-afzb) became the second biosimilar referencing Humira (adalimumab) to receive an interchangeable designation. The new label is intended to expand patient access to biosimilars.

FDA Approves First Tocilizumab Biosimilar

October 5th 2023

By Skylar Jeremias

Tofidence, a tocilizumab biosimilar developed by Biogen, will be used to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

Webinar: Experts Discuss Avenues to Improve Biosimilar Development Efficiency

October 4th 2023

By Skylar Jeremias

A recent webinar featured an in-depth discussion on the impacts that updated guidelines, a reduction in clinical efficacy testing, and biomarker analyses can have on the efficiency of biosimilar development.

BioRationality: Calling on Developers to Help Address Remaining Biosimilar Issues

October 3rd 2023

By Sarfaraz K. Niazi, PhD

Sarfaraz K. Niazi, PhD, summarized the citizen petitions he's filed to the FDA as well as changes he believes are needed to propel the biosimilar industry into the future, including calling on biosimilar manufacturers to help.