Tentative US approval for Symbicort generic

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Tentative US approval for Symbicort generic

Genéricos/Novedades | Posted 23/04/2021 0 Post your comment

On 8 March 2021, Viatris Inc and Kindeva Drug Delivery LP announced that the US Food and Drug Administration (FDA) has granted the tentative approval of their generic version of Symbicort® (budesonide/formoterol).

Viatris (previously Mylan and Upjohn [1]) and Kindeva’s new budesonide/formoterol fumarate dihydrate products are the first generic version of AstraZeneca's Symbicort based on an abbreviated new drug application (ANDA) in the US. The Symbicort originator is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD). In 2020, the US branded sales of Symbicort reached US$3.5 billion, according to IQVIA.

At present, the approval is tentative due to an ongoing patent litigation with AstraZeneca. At the beginning of March, the US District Court for the Northern District of West Virginia found that the Symbicort patents are not invalid for obviousness. Viatris and Kindeva disagree with this decision and intent to file an appeal to challenge the patent validity. In the meantime, the trial court decision prevents commercial launch at present.

Despite the current legal status, Viatris and Kindeva are committed to bringing their generic Symbicort to market as soon as possible. This is thought to be after 2021 as Viatris does not have any planned revenue from this generic this year.

Teva wins another Symbicort patent challenge

LATIN AMERICAN FORUM – Coming soon! To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America. Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM – Próximamente! Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica. Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa.

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Mylan Upjohn merger receives go ahead from Europe Australia and New Zealand [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 23]. Available from: www.gabionline.net/Pharma-News/Mylan-Upjohn-merger-receives-go-ahead-from-Europe-Australia-and-New-Zealand

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