Tentative US approval for Symbicort generic

Generics/News | Posted 23/04/2021 post-comment0 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).

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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.

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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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