Amgen has received approval from the US Food and Drug Administration (FDA) for Avsola (infliximab-axxq), a biosimilar to Johnson & Johnson’s Remicade (infliximab).
The approval enables the use of the drug to treat moderate-to-severe rheumatoid arthritis (RA), Crohn’s disease (CD) and ulcerative colitis (UC), chronic severe plaque psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS).
Avsola is a monoclonal antibody that targets tumour necrosis factor alpha. The drug obtained approval for all indications of the reference product in the US.
Analytical, non-clinical and clinical studies demonstrated that Amgen’s drug is highly similar to Remicade without any clinically meaningful differences.
Among others, the comparative data included findings of a pharmacokinetic (PK) similarity study in healthy individuals and a comparative clinical study in moderate-to-severe RA patients.
The randomised, double-blind comparative study investigated the safety and efficacy of 3mg / kg Avsola, compared to 3mg / kg Remicade, in 558 patients.
Participants were given an infusion on day one, at weeks two and six, followed by every eight weeks.
The primary endpoint was the response difference (RD) of 20% improvement at week 22 on the American College of Rheumatology core set measurements (ACR20).
Principal secondary endpoints included DAS28-CRP change from baseline, RD of ACR20, ACR50 and ACR70 at weeks two, six, 14, 22, 30, 34, 38, 46 and 50.
Furthermore, the study assessed a single transition from Remicade to Avsola at week 22 in 119 subjects. Results found similar safety and immunogenicity in participants previously given Remicade, said Amgen.
Amgen Global Commercial Operations executive vice-president Murdo Gordon said: “Following July’s exciting launches of our two biosimilars in oncology, AVSOLA highlights Amgen’s long-term commitment to providing more affordable biological treatment options to patients across critical disease states, including chronic inflammatory conditions.”
The company’s biosimilar portfolio comprises ten medicines. Four hold US regulatory approval, while three have secured authorisations in the European Union (EU).