Amgen confirms it is working on a version of Alexion's drug

Amgen developing Soliris biosimilar

By Gareth Macdonald contact

- Last updated on GMT

iStock/CharlieAJA
iStock/CharlieAJA

Related tags: Pharmacology, Food and drug administration

Amgen has started a trial of a biosimilar version of Alexion Pharmaceuticals’ Soliris (Eculizumab).

The study - which was posted on the Australia New Zealand Clinical Trial Registry in April​ – is comparing the pharmacokinetic profile of Amgen’s candidate ABP 959 with Alexion’s drug in healthy male subjects.

Soliris is a humanized monoclonal antibody that inhibits an immune system protein - Complement component 5 - that is associated with damaging inflammatory responses in a number of diseases. 

It is approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Cost

Soliris is one of the most expensive medicines in the world.

According to the British national formulary ​it costs £3150 per 30 ml vial, excluding VAT.

NICE​, the organisation that decides which drugs and treatments are available on the NHS in Wales and England, estimates that Solris costs "£340,200 (initial and maintenance treatment) in the first year of treatment and about £327,600 for 1 year of treatment on the recommended maintenance dose.​"

One of nine

An Amgen spokeswoman confirmed the firm is working on a version of the drug.

"All that we can say at this time is that Amgen has nine biosimilars in development, including a biosimilar candidate to Soliris. We look forward to providing further updates at the appropriate time​."

Amgen is not the only firm working on a Soliris biosimilar.

According to a recent SEC filing​ Epirus Biopharmaceutical is also developing a version of the product called BOW080​.

On its website​ Boston-based Epirus states it expects to file the drug in 2020.

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