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Amgen trials Soliris biosim in Aust
Posted 23 June 2016
Amgen has set its sights on reputedly the world's most expensive drug - Alexion's Soliris (eculizumab) - readying its own biosimilar for trial in Australia.
The company has registered a phase I randomised double-blind trial for ABP959 to determine its pharmacokinetic similarity with EU and US registered versions of Soliris in healthy male subjects on the Australian New Zealand Clinical Trials Registry.
The secondary outcome is to determine safety and tolerability, and immunogenicity of the biosimilar.
ABP959 will be studied in atypical haemolytic uraemic syndrome (aHUS), complement-mediated thrombotic microangiopathy, paroxysmal nocturnal haemoglobinuria (PNH) and haemolysis. Soliris is listed on the life saving drugs program for PNH and on the PBS for aHUS.
Participants will be randomised to Soliris or Amgen's biosimilar and given one dose. Blood samples will be taken regularly and patients monitored until day 57, which is the end of the study.
Amgen has quite a few biosimilar products in development at the moment, including ones for AbbVie's Humira (adalimumab), Roche's Herceptin (trastuzumab), Avastin (bevacizumab) and Mabthera (rituximab), Janssen's Remicade (infliximab) and Merck's Erbitux (cetuximab).
ABP959 is not even officially listed on the company's pipeline of biosimilars in development at the moment - though a note on the website states it has three biosimilar programs in product development which are undisclosed.
The trial aims to enrol 210 patients, with recruitment centres in Melbourne and Adelaide. The anticipated date for last participant enrolment is 30 June.
Epirus, a biopharma based in the Netherlands, is another company currently developing a biosimilar for Soliris.
Michelle Lam
michelle.lam@lushmedia.com.au
Posted 23 June 2016
Amgen has set its sights on reputedly the world's most expensive drug - Alexion's Soliris (eculizumab) - readying its own biosimilar for trial in Australia.
The company has registered a phase I randomised double-blind trial for ABP959 to determine its pharmacokinetic similarity with EU and US registered versions of Soliris in healthy male subjects on the Australian New Zealand Clinical Trials Registry.
The secondary outcome is to determine safety and tolerability, and immunogenicity of the biosimilar.
ABP959 will be studied in atypical haemolytic uraemic syndrome (aHUS), complement-mediated thrombotic microangiopathy, paroxysmal nocturnal haemoglobinuria (PNH) and haemolysis. Soliris is listed on the life saving drugs program for PNH and on the PBS for aHUS.
Participants will be randomised to Soliris or Amgen's biosimilar and given one dose. Blood samples will be taken regularly and patients monitored until day 57, which is the end of the study.
Amgen has quite a few biosimilar products in development at the moment, including ones for AbbVie's Humira (adalimumab), Roche's Herceptin (trastuzumab), Avastin (bevacizumab) and Mabthera (rituximab), Janssen's Remicade (infliximab) and Merck's Erbitux (cetuximab).
ABP959 is not even officially listed on the company's pipeline of biosimilars in development at the moment - though a note on the website states it has three biosimilar programs in product development which are undisclosed.
The trial aims to enrol 210 patients, with recruitment centres in Melbourne and Adelaide. The anticipated date for last participant enrolment is 30 June.
Epirus, a biopharma based in the Netherlands, is another company currently developing a biosimilar for Soliris.
Michelle Lam
michelle.lam@lushmedia.com.au
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