With Infliximab (Flixabi), a huge biosimilar medicine has been approved in the European Union (EU)

With Infliximab (Flixabi), a huge biosimilar medicine has been approved in the European Union (EU)

Last Updated on June 22, 2016 by Joseph Gut – thasso

 June 22, 2016 – The European Medicines Agency (EMA) has approved, as of the end of May 2016, Infliximab (Flixabi). Infliximab (Flixabi) is a monoclonal antibody that has been designed to attach to a protein called tumour necrosis factor-alpha (TNF-alpha) and block its activity. TNF-alpha is involved in causing inflammation Infliximaband is found at high levels in patients with the diseases that Infliximab (Flixabi) is used to treat. By blocking TNF-alpha, infliximab improves the inflammation and other symptoms of these diseases. Infliximab (Flixabi) is also a ‘biosimilar medicine’.  This means that Infliximab (Flixabi) is similar to a biological medicine (also known as the ‘reference medicine’) that is already authorised in the European Union (EU), namely Infliximab (Remicade). Note here that previously, EMA had already approved the biosimilar Infliximab (Rcmsima) in September 2013.

Infliximab (Flixabi) is indicated as an anti-inflammatory medicine usually when other medicines or treatments have failed or cannot be used for various clinical reasons in the treatment of the following diseases:

  • rheumatoid arthritis (an immune-system disease causing inflammation of the joints). Infliximab (Flixabi) is used with methotrexate (a medicine that acts on the immune system);
  • Crohn’s disease (a disease causing inflammation of the gut), when the disease is moderate to severe or causes fistulae (abnormal passageways between the gut and other organs);
  • ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);
  • ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine);
  • psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints);
  • psoriasis (a disease causing red, scaly patches on the skin).

Moreover, Infliximab (Flixabi) is also used in patients aged between 6 and 17 years with severe Crohn’s disease or ulcerative colitis, when they have not responded to or cannot take other medicines or treatments.

Overall, clinical studies have shown that Infliximab (Flixabi) is comparable to Infliximab (Remicade) in its efficacy, including a study to show that it produces levels of the active substance in the body similar to those achieved with treatment of patients with the same doses of Infliximab (Remicade). Infliximab (Flixabi) was also compared with Infliximab (Remicade) in one main study involving 584 patients with moderate to severe rheumatoid arthritis who had received previous treatment with methotrexate. The main measure of effectiveness was the proportion of patients who achieved at least a 20% reduction in ACR scores (a measure of painful, swollen joints and other symptoms) after 30 weeks of treatment. Results of this study showed that Infliximab (Flixabi) was as effective as Infliximab (Remicade) in reducing symptoms of rheumatoid arthritis: 64% of those treated with Infliximab (Flixabi) (148 of 231 patients) had at least a 20% reduction in ACR scores, compared with 66% of those given Infliximab (Remicade) (163 out of 247).

As Infliximab (Remade), Infliximab (Flixabi) comes with a set of clinical adverse effects. Thus, the most common side effects with Infliximab (Flixabi) (seen in more than 1 patient in 10) are viral infections (such as flu or cold sores), headache, upper-respiratory-tract infection (colds), sinusitis (inflammation of the sinuses), nausea (feeling sick), abdominal pain (stomach ache), infusion-related reactions and pain. Some side effects, including infections, may be more common in children than in adults. In addition, Infliximab (Flixabi) must not be used in patients who are hypersensitive (allergic) to infliximab, mouse proteins or any of the other ingredients of Infliximab (Flixabi). Infliximab (Flixabi) must also not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure (an inability of the heart to pump enough blood around the body).

Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

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