Biologics are the fastest-growing class of medications in the United States and account for a substantial and growing portion of health care costs. The Biologics Price Competition Act of 2009 created an abbreviated approval pathway for the U.S. 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.
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 .
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 .
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 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.
Samsung Bioepis and Organon announced topline results from interchangeability study of their Humira biosimilar, SB5/Hadlima, in August 2023.
A comprehensive review conducted by Queiroz et al. in 2023  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.
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 , reveals the views of prescribing ophthalmology physicians in Canada on product identification, prescribing biologicals and prescribing biosimilars and switching.
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 . In response to this article, Dr Robin Thorpe, Deputy Editor-in-Chief of the journal has published a rebuttal , providing insightful counterpoints to the concerns raised by the authors.
The cost of developing biosimilars can be prohibitively expensive. A manuscript published in GaBI Journal entitled 'Biosimilars drug development: time for a paradigm shift?' , explores ways in which we can see leaner and faster biosimilar clinical trials, without compromise on safety and efficacy of the drug products.