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Alexion delays Soliris biosimilar until 2025 Posted 28/08/2020

Alexion Pharmaceuticals has reached a patent settlement with Amgen over Soliris (eculizumab), Alexion’s blockbuster antibody treatment for the blood disease paroxysmal nocturnal haemoglobinuria (PNH). The agreement prevents Amgen’s biosimilar version of Soliris from entering the US market until 2025.

Eculizumab is a monoclonal antibody, primarily used for the treatment of the life-threatening blood disease paroxysmal nocturnal disease PNH. The drug reduces the loss of red blood cells and therefore the need for blood transfusion in  disease PNH.

Eculizumab is also indicated for the treatment of atypical haemolytic uraemic syndrome (aHUS), a rare genetic disease of the immune system, and neuromyelitis optica, an autoimmune disease affecting the nervous system.

The drug has been sold as Soliris by Alexion Pharmaceuticals since 2007 and in 2010 was the most expensive drug in the world, with costs in the US of over $400,000 per year. Sales of the drug in 2019 were almost US$4 billion.

Although trials of non-originator versions of the drug have begun in China [1] and South Korea [2], and one such drug has been approved in Russia [3], there are no biosimilar versions available on the US market as Alexion’s initial patent covering Soliris is valid until March 2022. Additional patents expire in March 2027.

In a recent patent settlement, Alexion have prevented the release of Amgen’s Soliris biosimilar until 1 March 2025. The deal was reached on 28 May 2020 and settles three Inter Partes Review (IPR) proceedings for patents on Soliris.

Amgen filed the IPR petitions in February 2019, against three patents covering the eculizumab antibody, eculizumab pharmaceutical composition, and methods of treating PNH. Under the agreement, Amgen have agreed to terminate the IPRs and Alexion have granted Amgen a non-exclusive, royalty-free licence to make and sell their eculizumab biosimilar from March 2025. It was previously suggested that, if their case was successful, Amgen could launch their biosimilar by 2022.

It is thought the deal will buy Alexion time to protect its follow-up medication Ultomiris (ravulizumab), which is also indicated for treatment of PNH. Ultomiris was developed from eculizumab and is designed to have a longer lasting effect.

Amgen’s eculizumab biosimilar, ABP 959, is currently in the clinical trial stages. In combination with the news that UnitedHealthcare – the biggest insurer in the US – will preferentially cover Amgen’s anticancer biosimilars [4], the company has a good chance of gaining significant market share with ABP 959.

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References
1.GaBI Online - Generics and Biosimilars Initiative. Phase III trial started in China for eculizumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Aug 28]. Available from: www.gabionline.net/Biosimilars/News/Phase-III-trial-started-in-China-for-eculizumab-copy-biological 
2. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis starts phase III trial for eculizumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Aug 28]. Available from: www.gabionline.net/Biosimilars/News/Samsung-Bioepis-starts-phase-III-trial-for-eculizumab-copy-biological 
3. GaBI Online - Generics and Biosimilars Initiative. Russian approval for non-originator eculizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Aug 28]. Available from: www.gabionline.net/Biosimilars/News/Russian-approval-for-non-originator-eculizumab
4. GaBI Online - Generics and Biosimilars Initiative. UnitedHealthcare to preferentially cover Amgen’s anticancer biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Aug 28]. Available from: www.gabionline.net/Biosimilars/General/UnitedHealthcare-to-preferentially-cover-Amgen-s-anticancer-biosimilars 

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