Alvotech and Teva Pharmaceuticals announced in January 2023, that the US Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for AVT04, Alvotech’s proposed biosimilar to Stelara® (ustekinumab). Meanwhile, Biocon Biologics received a complete response letter (CRL) from FDAregarding its application for an insulin aspart biosimilar (filed by its partner Viatris).
Ustekinumab is indicated for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis, and the originator is Janssen’s Stelara [1]. The patents on Stelara will expire in the US in September 2023 and in Europe in January 2024, making this the ideal time for the Alvotech-Teva product to be approved. Ustekinumab is a humanized monoclonal antibody that interferes with the triggering of the body’s inflammatory response through the suppression of certain cytokines. Specifically, it blocks interleukin IL 12 and IL 23 which help activate certain T cells. It binds to the p 40 subunit of both IL 12 and IL 23 so that they subsequently cannot bind to their receptors [1].
Alvotech and Teva entered a strategic partnership in August 2020, under the terms of which they will develop and bring to market several biosimilars, including this ustekinumab candidate [2]. In May 2022, Alvotech announced that AVT04 had met its primary endpoint in a clinical, safety and efficacy study and demonstrated therapeutic equivalence with the reference product in patients with moderate to severe chronic plaque-type psoriasis. This came following top-line results from a pharmacokinetic (PK) similarity study for AVT04.
Also in January 2023, Biocon Biologics announced that FDA has issued a CRL for the BLA for the insulin-R product, a proposed biosimilar for diabetes treatment.
The CRL cites additional data required in the BLA submission and an expectation of a satisfactory implementation of a CAPA (Corrective and Preventive Action) plan pertaining to the pre-approval inspection of Bangalore facilities in August 2022.
Back in October 2022, FDA issued a CRL for Biocon’s BLA for insulin aspart. Although no outstanding scientific issues with the product were identified, the CRL references the Form 483 observations noted during the pre-approval inspection of Biocon Biologics’ integrated insulins manufacturing facility at Malaysia in August 2022.
However, the three manufacturing sites in Malaysia and India of Biocon Biologics received FDA’s establishment inspection reports in April 2020 [3].
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Clinical trials begin for ustekinumab biosimilars
Alvotech signs agreement for ustekinumab biosimilar Stelara in Japan
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jan 20]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
2. GaBI Online - Generics and Biosimilars Initiative. Teva changes course in Japan and the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jan 20]. Available from: www.gabionline.net/pharma-news/Teva-changes-course-in-Japan-and-the-US
3. GaBI Online - Generics and Biosimilars Initiative. US FDA clears Biocon manufacturing sites in Malaysia and India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jan 20]. Available from: www.gabionline.net/biosimilars/general/US-FDA-clears-Biocon-manufacturing-sites-in-Malaysia-and-India
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