The US Food and Drug Administration (FDA) rejected Alvotech’s biologicals licence application (BLA) for their biosimilar adalimumab AVT02 in June 2023. Alvotech has also formed new partnerships with Prolifarma and Advanz Pharma for proposed biosimilars to Eylea (aflibercept) and Xolair (omalizumab), respectively.
FDA rejection of biosimilar adalimumab AVT02
FDA has issued a complete response letter (CRL) for AVT02 which will further delay the Icelandic company’s plans to launch the product.
In the CRL, FDA highlighted deficiencies in Alvotech’s Reykjavik manufacturing facility. The company has previously received two other CRLs related to their Reykjavik plant, in April 2023 and September 2022.
Adalimumab is a monoclonal antibody used to treat a range of inflammatory conditions including rheumatoid arthritis, psoriatic arthritis, and inflammatory bowel disease (IBD) [1]. The reference product is AbbVie’s Humira.
The Alvotech adalimumab biosimilar, AVT02, has already received approval in many countries across the world as a high-concentration low-volume version of adalimumab, including Europe [2], Japan, Canada and Switzerland [3], under different partnerships and with brand names including Hukyndra, Libmyris and Simlandi.
Following the CRL, Alvotech intends to resubmit a BLA for AVT02, including data supporting an interchangeability designation, to FDA, which would trigger a six-month review period and a new Biosimilar User Fee Act (BsUFA) date.
Due to the delay in the potential approval of AVT02 in the US, Alvotech is now exploring options to raise additional capital, in order to continue advancing pipeline development.
Prolifarma partnership for aflibercept biosimilar AVT06
In May 2023, Alvotech announced that it has entered into an exclusive agreement with Prolifarma for the commercialization in Turkey of AVT06, a proposed biosimilar to Eylea (aflibercept).
Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor. It is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy in patients with diabetic macular oedema [4].
The originator product, Regeneron’s Eylea (aflibercept), was approved by FDA in November 2011 and by the European Medicines Agency (EMA) in November 2012 [5].
AVT06 is currently still in clinical development. In July 2022, Alvotech announced the initiation of a patient study to compare AVT06 and Eylea in terms of efficacy, safety and immunogenicity in adult patients with neovascular (wet) AMD.
Advanz Pharma partnership for biosimilar omalizumab
Alvotech enters into commercialization agreement with Advanz Pharma for proposed biosimilar to Xolair (omalizumab), AVT23, in February 2023.
Omalizumab is a recombinant DNA-derived humanized IgG1k monoclonal antibody that specifically binds to free human immunoglobulin E (IgE) in the blood and interstitial fluid and to membrane-bound form of IgE (mIgE) on the surface of mIgE-expressing B lymphocytes [1]. Omalizumab is used to treat asthma, as well as nasal polyps and chronic idiopathic urticaria (itchy rash). It is sold under the brand name Xolair by Novartis.
In this agreement, Advanz Pharma will commercialize AVT23 in the European Economic Area, UK, Switzerland, Canada, Australia and New Zealand. The estimated market size of the reference product for the region included under this agreement is over US$1 billion, according to market data from IQVIA.
In both the agreement with Prolifarma and Advanz, Alvotech will be responsible for development and manufacture, while Prolifarma and Advanz Pharma will handle market registration and commercialization.
Related article
Humira (adalimumab) biosimilars pipeline
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 3]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-adalimumab
2. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of two adalimumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 3]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-two-adalimumab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Advances for Alvotech’s partnerships in Japan, Canada and Switzerland [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 3]. Available from: www.gabionline.net/biosimilars/news/advances-for-alvotech-s-partnerships-in-japan-canada-and-switzerland
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of aflibercept [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 3]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-aflibercept
5. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
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