Danish Registry Analysis Finds Consistent Safety After Switching to Infliximab Biosimilar GP1111

Biosimilars Council Position Paper Calls for End to Clinical Efficacy Trials for Biosimilars

June 4th 2024

By Skylar Jeremias

In a position paper from the Biosimilars Council, the organization points to evidence showing that clinical efficacy trials are a major barrier to biosimilar access in the US, calling for the FDA to change its policies to remove them in favor of other comparators.

BioRationality: FDA Updates Its Biosimilars Action Plan—A Major Step in Bringing More Biosimilars to Patients

June 3rd 2024

By Sarfaraz K. Niazi, PhD

Sarfaraz K. Niazi, PhD, analyzes updates to the FDA's Biosimilars Action Plan, as well as the agency's increased efforts to boost biosimilar adoption and education.

Biosimilars Gastroenterology Roundup for May 2024—Podcast Edition

June 2nd 2024

By Skylar Jeremias

On this episode of Not So Different, we review the biggest gastroenterology biosimilar stories from May 2024, covering new data from conferences and journals on infliximab and adalimumab products that demonstrate positive clinical results and confirm the safety of these biosimilars, as well as the feasibility of switching to them.

Posters Capture Clinical Impacts of Infliximab in Super-Responders, Pregnant Patients With IBD

June 1st 2024

By Skylar Jeremias

Posters from Digestive Disease Week 2024 look at how super-responders and pregnant patients with inflammatory bowel disease (IBD) react to treatment with subcutaneous infliximab and an infliximab biosimilar, respectively.

The Top 5 Biosimilar Articles for the Week of May 27

May 31st 2024

By Cameron Santoro

Here are the top 5 biosimilar articles for the week of May 27, 2024.

Biosimilars Gastroenterology Roundup: May 2024

May 30th 2024

By Skylar Jeremias

May proved to be a big month for biosimilar research, particularly in the gastroenterology space, where new data on infliximab and adalimumab products from conferences and journals alike demonstrated positive clinical results showcasing the safety of these products as well as switching to them.

Managing Treatment Strategies for Osteoporosis Amid Evolving Biologic and Biosimilar Landscape

May 30th 2024

Jeffrey Curtis, MD, MS, MPH, provides expert perspective for navigating the evolving treatment landscape of osteoporosis and key considerations for biologic and biosimilar utilization.

FDA Approves First Eculizumab Biosimilar

May 29th 2024

By Skylar Jeremias

The FDA approved Bkemv (eculizumab-aeeb) as the first biosimilar to Soliris (eculizumab) for 2 rare diseases. It was also approved with interchangeability.

New Evidence Confirms Safe Biosimilar-to-Biosimilar Switching

May 28th 2024

By Skylar Jeremias

A literature review revealed new data demonstrating that biosimilar-to-biosimilar switching is safe and effective.

Eye on Pharma: Simlandi US Launch; Ranibizumab Partnership; Expanded Access for Adalimumab Biosimilars

May 27th 2024

By Skylar Jeremias

Alvotech and Teva have launched Simlandi in the US; Xbrane Biopharma and STADA Arzneimitel partner with Valorum Biologics to bring a ranibizumab biosimilar to the US; Boehringer Ingelheim and Celltrion take steps to expand access to their respective adalimumab biosimilars.