Biosimilars/Research

Biological therapies for psoriasis: evaluating durability and persistent benefits

Biosimilars/Research | Posted 05/12/2023

A review by Rusiñol et al. emphasized the significant impact of biologicals on psoriasis management. Anti-IL-17 and anti-IL-23 biologicals are regarded as highly effective and long-lasting treatments in real-world scenarios, with IL-23-targeting biologicals showing the best safety profile and potential to modify the natural course of psoriasis.

Switches between biosimilars and their reference products

Biosimilars/Research | Posted 28/11/2023

Biologicals are the fastest-growing class of medications in the United States and account for a substantial and growing portion of healthcare costs. The Biologics Price Competition Act of 2009 created an abbreviated approval pathway for the US Food and Drug Administration (FDA) to help provide patients with greater access to safe and effective biological products. As of 1 November 2023, FDA has approved 44 biosimilar products, 7 of which are interchangeable biosimilars. These products can be used to treat many conditions such as chronic skin and bowel diseases, arthritis, kidney conditions, diabetes, multiple sclerosis, macular degeneration, and cancer.

Latin America's biosimilars market: regulatory, institutional, and technological aspects

Biosimilars/Research | Posted 21/11/2023

According to a study led by Bas (2023), the Latin American (LA) biosimilars market is positioned for substantial growth over the next decades as a cost-effective alternative to expensive patented biomolecules [1].

Impact of trastuzumab biosimilars use in metastatic HER2-positive breast cancer

Biosimilars/Research | Posted 07/11/2023

A review conducted by Sarder and Ahmad attempted to describe and analyse the studies published in peer-reviewed literature on the use of trastuzumab biosimilars for patients with HER2-positive breast cancer, including their efficacy, safety, pharmacokinetic and pharmacodynamic properties [1].

Biosimilar anti-VEGF: transforming retina treatment economics in South Asia

Biosimilars/Research | Posted 24/10/2023

Anti-vascular endothelial growth factors (anti-VEGF) agents combat retinal diseases causing blindness. However, high costs and non-adherence pose challenges. Ophthalmic anti-VEGF ranibizumab biosimilars, which have received multiple approvals in South Asia, are helping to reduce healthcare costs and revolutionize ophthalmic treatments.

Long-term data support the clinical comparability of AVT04 to Stelara

Biosimilars/Research | Posted 17/10/2023

Long-term efficacy, safety and tolerability data for the AVT04 ustekinumab biosimilar candidate developed in partnership by Alvotech and STADA corroborate the finding of therapeutic equivalence to the Stelara® reference product in patients with moderate-to-severe chronic plaque psoriasis (PsO) in the primary endpoint at Week 12.

Topline results for Hadlima biosimilar in interchangeability study

Biosimilars/Research | Posted 10/10/2023

Samsung Bioepis and Organon announced topline results from interchangeability study of their Humira biosimilar, SB5/Hadlima, in August 2023.

IBD barriers: an analysis of Latin America

Biosimilars/Research | Posted 03/10/2023

A comprehensive review conducted by Queiroz et al. in 2023 [1] explores the barriers to accessing IBD care throughout Latin America, a large and diverse region used to describe South America, Central America, Mexico and the islands of the Caribbean. Each one of these regions/countries carries a different cultural and historical background, diverse political systems and a distinct healthcare system.

Ophthalmology biosimilars in Canada: a prescriber’s perspective

Biosimilars/Research | Posted 15/09/2023

The first biosimilar entered the Canadian market in 2009 and the first ophthalmic biosimilar was approved in 2022. Now, a report based on the results of a 2022 survey [1], reveals the views of prescribing ophthalmology physicians in Canada on product identification, prescribing biologicals and prescribing biosimilars and switching.

Response to Opinion on: Four steps for streamlining biosimilars development

Biosimilars/Research | Posted 18/08/2023

In the Opinion article, 'Biosimilars drug development: time for a paradigm shift?' published in GaBI Journal, the authors question the need for what they consider to be the arduous regulatory requirements for approval of biosimilars [1]. In response to this article, Dr Robin Thorpe, Deputy Editor-in-Chief of the journal has published a rebuttal [2], providing insightful counterpoints to the concerns raised by the authors.