Biocon and Lupin launch generic tacrolimus capsules in US

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Biocon and Lupin launch generic tacrolimus capsules in US

Genéricos/Novedades | Posted 05/02/2021 0 Post your comment

India-based generics makers Biocon and Lupin have both launched generic tacrolimus capsules in the US.

Biocon announced its launch of generic tacrolimus capsules in the US on 28 December 2020. The launch follows an approval from FDA in November 2020.

Lupin announced on 25 November 2020 that it had launched tacrolimus capsules at doses of 0.5 mg, 1 mg, and 5 mg, after Lupin’s alliance partner Concord Biotech (Concord) received an approval for its abbreviated new drug application (ANDA) from the US Food and Drug Administration (FDA).

Tacrolimus, a calcineurin inhibitor, is an immunosuppressant used in the treatment of organ transplant patients. It reduces the body’s ability to reject a transplanted organ and has been used for the treatment of renal transplant patients for more than two decades.

The products from Biocon and Lupin are generics of Astellas Pharma’s Prograf (tacrolimus) and are indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant, liver transplant and heart transplant, and in paediatric patients receiving allogeneic liver transplants, in combination with other immunosuppressants.

Prograf (0.5 mg, 1 mg, and 5 mg) had annual sales of approximately US$303 million up to September 2020 in the US, according to the IQVIA Institute.

The European Medicines Agency recommended approval of Teva Pharmaceutical’s tacrolimus generic Tacforius on 12 October 2017 [1]. This was followed by European Commission approval in December 2017.

Follow-up study finds generic tacrolimus safe for kidney transplant patients

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. EMA approval for tacrolimus generic [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 5]. Available from: www.gabionline.net/Generics/News/EMA-approval-for-tacrolimus-generic

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Source: Biocon, Lupin