Sandoz, the generics division of Novartis, and Poland-based Polpharma Biologics announced on 3 September 2019 that they had signed a worldwide agreement giving Sandoz commercialization rights to Polpharma’s candidate natalizumab biosimilar (PB006).
Natalizumab is a humanized monoclonal antibody against the cell adhesion molecule α4-integrin. Natalizumab is believed to work by reducing the ability of inflammatory immune cells to attach to and pass through the cell layers lining the intestines and blood–brain barrier. Natalizumab is indicated for the treatment of multiple sclerosis (US and Europe) and Crohn’s disease (US).
PB006 is currently in phase III clinical development for the treatment of relapsing-remitting multiple sclerosis (RRMS).
Under the terms of the agreement, Polpharma Biologics will be responsible for the development, manufacturing and supply of the biosimilar. Once approved, Sandoz will commercialize and distribute the biosimilar in all markets via an exclusive global license.
The originator product, Biogen Idec and Elan’s Tysabri (natalizumab), had worldwide sales of US$1.9 billion in 2018 [1]. The patents on Tysabri expired in the US in March 2015 and in Europe in August 2015 [2].
Polpharma, which the largest Polish manufacturer of pharmaceuticals, secured a loan from the European Investment Bank (EIB) of Euros 45 million (around Zloty 185 million) for its research into, and development of, biosimilars back in 2015 [3].
In addition to natalizumab, Polpharma is also working on five other biosimilars. Ranibizumab is being developed in partnership with Bioeq IP AG and is reported to be in phase III development. While ustekinumab (PB007) is reported to be in late-stage technical development. The other three biosimilars are undisclosed, but are all in early to late-stage technical development.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of natalizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 20]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-natalizumab
2. 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
3. GaBI Online - Generics and Biosimilars Initiative. Polish firm gets EIB loan for biosimilars development [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 20]. Available from: www.gabionline.net/Biosimilars/General/Polish-firm-gets-EIB-loan-for-biosimilars-development
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Source: Novartis, Polpharma
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