Development

Published Data Coupled With Real-world Evidence Show Safety of Biosimilar-to-Biosimilar Switching

March 22nd 2023

By Skylar Jeremias

Article

At the Festival of Biologics, Hillel Cohen, the executive director of scientific affairs at Sandoz, shared the current body of literature on biosimilar-to-biosimilar switching, saying that although there isn’t much published data, the vast real-world experience demonstrates the safety of this type of medication switch.

Uptake Barriers Will Deter Future Competitors From Investing in Biosimilars, Julie Reed Warns

March 21st 2023

By Skylar Jeremias

Article

At the Festival of Biologics, Juliana (Julie) Reed, executive director of the Biosimilars Forum, warned that without changes to encourage biosimilar uptake, companies will begin to ask the big question: Are biosimilars worth investing in?

Samsung Bioepis’ Stelara Biosimilar Proves Successful in Phase 1 Study

March 20th 2023

By Skylar Jeremias

Article

At the American Academy of Dermatology annual meeting, Samsung Bioepis shared positive results from a phase 1 study comparing its ustekinumab biosimilars (SB17) with the reference product (Stelara).

Contributor: FDA Introduces New AI-Based Safety Evaluation Tool to Help Demonstrate Biosimilarity

March 14th 2023

By Sarfaraz K. Niazi, PhD

Article

The FDA's new artificial intelligence (AI)-based modeling on characterizing protein aggregation could directly impact the safety assurance of biosimilars and other therapeutic proteins.

White Paper Argues Increased Competition Will Improve Biosimilar Uptake, Savings

March 8th 2023

By Skylar Jeremias

Article

A white paper touting biosimilar successes in the United States reasoned that increased market competition will help improve utilization rates, generate substantial savings, and encourage payers to cover biosimilars.

Dr Ivo Abraham Column: The 2022 WHO Biosimilar Guidelines—Loosening the Reins or Changing the Track? Part 2

March 7th 2023

By Ivo Abraham, PhD

Article

In part 2 of this 2-part series, Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, continued to examine guidelines from the World Health Organization (WHO) and how they view interchangeability and animal study requirements.

Celltrion Publishes Data on Maintenance Therapy Using Infliximab Biobetter

March 6th 2023

By Skylar Jeremias

Article

At the European Crohn’s and Colitis Organisation congress, Celltrion Healthcare shared positive safety and efficacy data on maintenance therapy including its infliximab biobetter allowing for subcutaneous administration, Remsima SC.

Review: 15 Years of Real-world Data Demonstrates Safety of Epoetin Alfa Biosimilar HX575

March 4th 2023

By Deana Ferreri, PhD

Article

Authors of a review of safety results across indications and study designs on the epoetin alfa biosimilar HX575 concluded that HX575 “has repeatedly demonstrated long-term safety” in all approved indications in both clinical trials and real-world studies.

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.