Dermatology

Switching Patterns Highlight Nocebo Effect in European Patients Using Amgevita

July 23rd 2024

By Skylar Jeremias

About half of the patients in a European study who transitioned from reference adalimumab to a biosimilar version stayed on the biosimilar at the 1-year mark. However, researchers warned about a possible nocebo effect resulting in some patients switching back to the originator.

Samsung Bioepis’ Ustekinumab Biosimilar Demonstrates PK Equivalence in Healthy Adults

July 6th 2024

By Deana Ferreri, PhD

Article

A phase 1 study demonstrated pharmacokinetic (PK) bioequivalence of the proposed ustekinumab biosimilar SB17 (Samsung Bioepis) to the EU- and US-sourced reference products.

Eye on Pharma: New Data, Clinical Developments, and Biosimilar Partnerships

July 4th 2024

By Skylar Jeremias

Article

As Celltrion publishes phase 3 data on its tocilizumab biosimilar, other companies finalize partnerships, and Formycon begins development for a pembrolizumab biosimilar.

FDA Approves Samsung Bioepis’ Pyzchiva, a Biosimilar to Stelara

July 1st 2024

By Skylar Jeremias

Article

Pyzchiva (ustekinumab-ttwe) is the third ustekinumab biosimilar to receive approval for the American market. It was also approved with interchangeability.

Biosimilar Adoption in the UK: Patient and Consultant Views on Safety and Switching

June 26th 2024

By Skylar Jeremias

Article

Lack of knowledge and confidence in biosimilars continues despite growing education efforts, impacting provider willingness to prescribe biosimilar medicines and patient perceptions about their treatment and switching to a biosimilar.

No Differences in Treatment Persistence, Safety Detected for Anti-TNF Biosimilars vs Originators

June 22nd 2024

By Deana Ferreri, PhD

Article

A real-world study using data from the French National Health Data System, found no significant differences in treatment persistence or safety between anti-tumor necrosis factor (TNF)-α biosimilars and reference products in all indications of these biologics.

FDA Draft Guidance Removes Switching Study Requirements for Biosimilar Interchangeability

June 20th 2024

By Skylar Jeremias

Article

The FDA has issued an update to its guidance on requiring switching study data for biosimilars to be granted interchangeability, citing new science that shows these studies aren’t needed to establish biosimilar safety.

Switching Patients With IBD to Infliximab, Adalimumab Biosimilars Did Not Impact Efficacy

June 8th 2024

By Deana Ferreri, PhD

Article

Researchers reviewed real-world evidence on the safety and effectiveness of switching from tumor necrosis factor-α inhibitor originators to biosimilars in inflammatory bowel disease (IBD), prompted by mandatory switching policies in most Canadian provinces.

New Evidence Confirms Safe Biosimilar-to-Biosimilar Switching

May 28th 2024

By Skylar Jeremias

Article

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

Article

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.