In the US, a bill was passed in late March 2022 to cap the monthly cost of insulin at US$35 for insured patients. In addition, in early April 2022, a bipartisan bill to reform the US Food and Drug Administration (FDA) review and approval process for complex generics/biosimilars was passed.
The Affordable Insulin Now Act
The Affordable Insulin Now Act passed in the House of Representatives as 232-193 and hopes to cap monthly insulin costs at US$35, bringing predictability to patients at a time of inflation. It plans to benefit both Medicare patients, who now face rising out-of-pocket costs, and those on minimalistic insurance plans. However, the uninsured will see no benefits. The legislation must now pass Congress before it can come into effect and, as it is part of Democrat President Joe Biden’s pledge to make prescription drugs more affordable in the US, it faces potential opposition from Republican senators. Despite possible opposition, the management of the rising cost of insulin in the US has been on the political agenda for some years and has bipartisan roots. FDA highlighted issues during a public meeting in 2019 which discussed access to affordable insulin products and issues related to the development and approval of biosimilar and interchangeable insulin products [1].
The Modernizing Therapeutic Equivalence Rating Determination Act
The Modernizing Therapeutic Equivalence Rating Determination Act hopes to reform the FDA review and approval process for complex generics/biosimilars in the US. It hopes to enable drugs submitted via the 505(b)(2) approval pathway to be granted therapeutic equivalence status and enable their automatic substitution with branded products at the pharmacy level. The 505(b)(2) pathway is a new drug application (NDA) mechanism, which leverages certain data from an already approved drug while providing data to support any differences to the approved drug. Following a 505(b)(2) approval, the new drug does not receive a therapeutic equivalence rating to the already approved, as it would do if it were an abbreviated new drug application (ANDA). Although it is possible to apply for therapeutic equivalence status following approval, the process is lengthy; for example, insulin glargine biosimilar Semglee (insulin glargine-yfgn) was approved on 28 July 2021 as the first interchangeable biosimilar product in the US for the treatment of diabetes [2].
It is hoped that, should the legislation pass, it will level the playing field between future newly approved drugs and brand-name products, improving their affordability and increasing access for patients. This could see particular benefits for the insulins market as follow-on (biosimilar) insulins are approved via the 505(b)(2) pathway, thus equivalence status would improve uptake and increase accessibility [3].
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| LATIN AMERICAN FORUM The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. View last week’s headline article: Nomenclatura de biológicos y biosimilares en Chile Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Vea el artículo principal de la semana pasada: Nomenclatura de biológicos y biosimilares en Chile !Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Comments on FDA’s plans to transition insulin products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 29]. Available from: www.gabionline.net/guidelines/Comments-on-FDA-s-plans-to-transition-insulin-products
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 29]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-insulin-glargine-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. The impact of insulin biosimilars on the diabetes landscape [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 29]. Available from: www.gabionline.net/biosimilars/research/the-impact-of-insulin-biosimilars-on-the-diabetes-landscape
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