As of September 2021, the US Food and Drug Administration (FDA) has reached an important milestone of approving more than 100 generic drug applications with a competitive generic therapy (CGT) designation.
The CGT programme was designed to encourage the development and marketing of generic drugs for products with little to no competition. Now, following the inception of FDA’s CGT programme in 2017, over 100 generic drug application approvals have been made in less than four years, among a broad range of products and therapeutic areas.
A key incentive provided by the programme is that applicants for drugs that receive a CGT designation may be eligible for a 180-day period of marketing exclusivity [1], if they are the first approved applicant for that CGT and meet certain other conditions.
This ‘100 approvals’ is a key milestone for the CGT programme which has spurred the development and market availability of safe and effective generic drugs in areas of the market that previously had little to no competition. This is a step towards providing patients with more affordable access to medicine across the US.
Despite this achievement, certain practices, such as delayed market entry [2], predatory pricing and a lack of supply chain partnerships, have reduced the impact that generic medicines could have had on the lives of patients. It has been reported that these issues have led to product supply chain disruptions, shortages, and high prices of generic drug products in recent years [3, 4]. As a result, there have been calls and a number of actions [5] to improve policy to facilitate the reach of generics. These are ongoing.
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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: Los datos apoyan la intercambiabilidad de los biosimilares de la UE 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: Los datos apoyan la intercambiabilidad de los biosimilares de la UE 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. US brand-name drug market exclusivity periods remain relatively unchanged over the past decade [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 12]. Available from: www.gabionline.net/generics/research/us-brand-name-drug-market-exclusivity-periods-remain-relatively-unchanged-over-the-past-decade
2. GaBI Online - Generics and Biosimilars Initiative. Lawsuits and US$450 million payout for price fixing and delayed generics entry [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 12]. Available from: www.gabionline.net/policies-legislation/lawsuits-and-us-450-million-payout-for-price-fixing-and-delayed-generics-entry
3. GaBI Online - Generics and Biosimilars Initiative. Why does the US face high-priced generics and drug shortages? [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 12]. Available from: www.gabionline.net/Generics/Research/Why-does-the-US-face-high-priced-generics-and-drug-shortages
4 GaBI Online - Generics and Biosimilars Initiative. The 700-dollar vitamin: excessive generics prices in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 12]. Available from: www.gabionline.net/generics/research/The-700-dollar-vitamin-excessive-generics-prices-in-the-US
5. GaBI Online - Generics and Biosimilars Initiative. US policy to combat high-priced generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 12]. Available from: www.gabionline.net/generics/research/US-policy-to-combat-high-priced-generics
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