Biosimilars
CVS Caremark removes Humira in the US and Sandoz launches Hyrimoz in Europe
It has been announced that the US’ CSV Caremark, a CVS Health company and one of the country’s largest pharmacy benefit managers (PBMs), will remove AbbVie’s Humira (adalimumab), from its major national commercial formularies effective 1 April 2024, in favour of biosimilar options. In Europe, Sandoz has launched its biosimilar Hyrimoz (adalimumab), a citrate-free high-concentration formulation (HCF) indicated for all conditions of the reference medicine.
EC approval of trastuzumab biosimilar Herwenda
The European Commission (EC) granted marketing authorization for trastuzumab biosimilar Herwenda on 15 November 2023. The biosimilar of Herwenda is developed by EirGenix, Inc.
EC approval of first ustekinumab biosimilar Uzpruvo
On 5 January 2024, the European Commission (EC) granted marketing authorization for the first ustekinumab biosimilar Uzpruvo (AVT04). The biosimilar of Uzpruvo is developed by Iceland-based biosimilar manufacturer Alvotech.
EMA recommends approval of ranibizumab biosimilar Rimmyrah
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use announced on 9 November 2023 that it had recommended granting of marketing authorization for Rimmyrah (ranibizumab), a biosimilar that references ophthalmology drug, Lucentis.
FDA approves Zymfentra and advances for Yuflyma in the US
On 23 October 2023, the US Food and Drug Administration (FDA) approved Celltrion’s Zymfentra (infliximab-dyyb) biosimilar as the first subcutaneous (SC) formulation of infliximab. In addition, Celltrion USA signed a contract with Ventegra to add Yuflyma (adalimumab-aaty) as a preferred formulary product in both public and private insurance markets.
Biological therapies for psoriasis: evaluating durability and persistent benefits
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
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.
EC approval of natalizumab, aflibercept and tocilizumab biosimilars
In September 2023, the European Commission (EC) granted marketing authorization for the biosimilars of Tyruko (natalizumab), Yesafili (aflibercept), and Tyenne (tocilizumab).
Latin America's biosimilars market: regulatory, institutional, and technological aspects
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].
EMA recommends approval of first ustekinumab biosimilar Uzpruvo
On 9 November 2023, the European Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Uzpruvo (ustekinumab), a biosimilar of reference product Stelara, intended for the treatment plaque psoriasis, including paediatric plaque psoriasis, psoriatic arthritis and Crohn’s disease in adults.
