View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
December 9, 2019

Amgen secures FDA approval for biosimilar drug Avsola

Amgen has received approval from the US Food and Drug Administration (FDA) for Avsola (infliximab-axxq), a biosimilar to Johnson & Johnson’s Remicade (infliximab).

Amgen has received approval from the US Food and Drug Administration (FDA) for Avsola (infliximab-axxq), a biosimilar to Johnson & Johnson’s Remicade (infliximab).

Free Report
img

What is the Global Healthcare and Pharma Market Q2 Outlook?

Given the background of high inflation, re-emerging supply chain issues, and the widespread macro-economic implications of the Ukraine conflict, the global pharmaceutical industry is facing an entirely new set of challenges following the turbulence of the COVID-19 pandemic. GlobalData’s World Markets Healthcare (WMH) service has released its latest Q2 forecast. This report incorporates the latest thinking on the opportunities and risks this new environment presents for pharma companies. However, the pharma sector is proving resilient, and we are projecting 4.4% global growth for the year ahead. Yet it remains that the current economic picture is inverting some baseline assumptions from previous quarterly forecasts and altering which markets we expect the key growth levers to derive from. Download our latest executive summary for a snapshot view of what our clients use to formulate winning strategies.
by GlobalData
Enter your details here to receive your free Report.

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).

Related Companies

Free Report
img

What is the Global Healthcare and Pharma Market Q2 Outlook?

Given the background of high inflation, re-emerging supply chain issues, and the widespread macro-economic implications of the Ukraine conflict, the global pharmaceutical industry is facing an entirely new set of challenges following the turbulence of the COVID-19 pandemic. GlobalData’s World Markets Healthcare (WMH) service has released its latest Q2 forecast. This report incorporates the latest thinking on the opportunities and risks this new environment presents for pharma companies. However, the pharma sector is proving resilient, and we are projecting 4.4% global growth for the year ahead. Yet it remains that the current economic picture is inverting some baseline assumptions from previous quarterly forecasts and altering which markets we expect the key growth levers to derive from. Download our latest executive summary for a snapshot view of what our clients use to formulate winning strategies.
by GlobalData
Enter your details here to receive your free Report.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. A weekly roundup of the latest news and analysis, sent every Friday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Pharmaceutical Technology