On 5 September 2022, Alvotech announced that it had received communication from the US Food and Drug Administration (FDA) that detailed the assessment of their Icelandic manufacturing facility and Alvotech’s subsequent written responses to FDA. This followed Strides announced the successful FDA inspection of their Singapore facility in early August 2022.
Alvotech’s Reykjavik facility and AVT02
The FDA’s Complete Response Letter (CRL) to the initial biosimilar Biologics License Application (BLA) for Alvotech’s Humira biosimilar (AVT02) has cited certain deficiencies related to the Reykjavik facility. FDA requires the satisfactory resolution of the deficiencies before it can approve the BLA.
In response, Alvotech has noted that it ‘aims to satisfactorily address the issues before the Biosimilar User Fee Act (BSUFA) goal date for the interchangeable biosimilar BLA in December’.
Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF), a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis [1].
Alvotech was finally able to submit the BLA following resolution with the originator producer, AbbVie [2]. AVT02 has already been approved in Europe and Canada [1, 3]. Alvotech has also announced that it will soon be filing for approval of its Stelara biosimilar in many regions.
Strides Singapore facility
The Strides manufacturing facility in Singapore underwent a successful inspection by US FDA. Following receipt of good manufacturing practice (GMP) certification, Strides’ biopharma arm Stelis Biopharma announced that it is now closer to US and EU approval of its biosimilar of Eli Lilly’s Forteo (teriparatide), a monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancers [4].
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References
1. GaBI Online - Generics and Biosimilars Initiative. AbbVie and Alvotech settle Humira (adalimumab) disputes [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 14]. Available from: www.gabionline.net/pharma-news/abbvie-and-alvotech-settle-humira-adalimumab-disputes
2. GaBI Online - Generics and Biosimilars Initiative. EMA and FDA accept application for adalimumab biosimilar AVT02 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 14]. Available from: www.gabionline.net/biosimilars/news/EMA-and-FDA-accept-application-for-adalimumab-biosimilar-AVT02
3. GaBI Online - Generics and Biosimilars Initiative. Canada approves adalimumab biosimilars Simlandi And Yuflyma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 14]. Available from: www.gabionline.net/biosimilars/news/canada-approves-adalimumab-biosimilars-simlandi-and-yuflyma
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of teriparatide [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 14]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-teriparatide
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