Development

Comparable Safety, Efficacy Between First Proposed Natalizumab Biosimilar, Reference for MS

March 3rd 2023

By Justina Petrullo

Article

Phase 3 study findings support a proposed natalizumab biosimilar (PB006) as the first biosimilar alternative to reference natalizumab (Tysabri) for treatment of relapsing-remitting multiple sclerosis (MS).

Dr Ivo Abraham Column: The 2022 WHO Biosimilar Guidelines—Loosening the Reins or Changing the Track? Part 1

February 28th 2023

By Ivo Abraham, PhD

Article

Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, details how biosimilar guidelines from the World Health Organization (WHO) have changed over time and whether those changes are beneficial for biosimilars in part 1 of this 2-part series.

ACR Supports Affordable Treatments, Use of Biosimilars Following Rigorous Approval Process

February 27th 2023

By Justina Petrullo

Article

The American College of Rheumatology (ACR) steadfastly supports the availability of safe and effective treatments for patients at the lowest cost possible, and underscores the necessity of scientific rigor for biosimilar use and approval.

Access 2023: FDA’s Dr Jacqueline Corrigan-Curay Gives Updates on Biosimilar, Generic User Fee Programs

February 22nd 2023

By Skylar Jeremias

Article

Jacqueline Corrigan-Curay, MD, JD, principal deputy center director of the FDA's Center for Drug Evaluation and Research, gave a keynote presentation at Access 2023 on how the Biosimilar User Fee Act and the Generic Drug User Fee Act have developed over the last year.

Contributor: The Promise of Biosimilars and the Harsh Reality of the US Market

February 20th 2023

By Kathy Oubre, MS

Article

In theory, by offering a lower-cost treatment option, biosimilars would help drive access for countless patients who simply could not afford the brand-name biologic. However, biosimilars have also encountered the harsh realities of the US health care system and its market forces.

FDA Issues CRL for Biocon Biologics, Viatris Avastin Biosimilar

February 14th 2023

By Skylar Jeremias

Article

Biocon Biologics and its partner Viatris received a complete response letter (CRL) for their biosimilar referencing Avastin (bevacizumab), the second CRL for the companies in 2023. The news comes as Biocon publishes increased revenues for biosimilars and generics.

What Will Be the Major Drivers Behind IQVIA's Predicted Biosimilars Uptake, Savings?

February 14th 2023

By Skylar Jeremias

Video

Adalimumab and ustekinumab biosimilars aren't the only factors that will drive biosimilar adoption and savings through 2023, according to Michael Kleinrock, lead research director for the IQVIA Institute for Human Data Science.

Preclinical Study Shows Comparability Between Omalizumab Biosimilar, Xolair

February 11th 2023

By Deana Ferreri, PhD

Article

The proposed omalizumab biosimilar KA (Shanghai Taiyin Biotechnology) demonstrated similar analytical characteristics, in vitro biological activity, and pharmacology and toxicology in animals compared with the originator (Xolair), according to investigators.

Phase 4 Study Finds Comparable Safety, Efficacy Between Etanercept Biosimilar, Enbrel for Autoimmune Diseases

February 10th 2023

By Justina Petrullo

Article

The first phase 4 postmarketing surveillance study for SB4 in South Korea as the first approved biosimilar of etanercept demonstrated comparable effectiveness and safety to previous SB4 evidence.

Seeing Eye to Eye: FDA's Dr Sarah Yim Discusses Efforts to Increase Confidence in Ophthalmology Biosimilars

January 29th 2023

By Skylar Jeremias

Podcast

On this episode of Not So Different, the FDA’s Sarah Yim, MD, discusses how the FDA is working to improve public trust in ophthalmology biosimilars and interchangeable products as part of a 3-part multimedia interview series.