A
biosimilar version of a monoclonal antibody (mab) drug named inflectra has been
approved for the first time in the EU. Hospira’s inflectra drug is a biosimilar
medicine to the reference medicinal product remicade. The detailed scientific
review and approval process by the european medicines agency and european
commission confirms that inflectra has demonstrated similar quality, efficiency
and safety to Remicade. The drug has been
approved for the treatment of inflammatory conditions including rheumatoid
arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis,
psoriatic arthritis (psa) and psoriasis.
These drugs are responsible for some of the highest medicinal costs for many countries. The introduction of biosimilar mabs in europe is expected to deliver savings of up to €20.4 billion by 2020, with the biggest savings predicted in France, Germany and the UK. Inflectra offers physicians, patients and healthcare systems a more affordable treatment option as well as maintaining similar quality and safety to its reference product - remicade.
These drugs are responsible for some of the highest medicinal costs for many countries. The introduction of biosimilar mabs in europe is expected to deliver savings of up to €20.4 billion by 2020, with the biggest savings predicted in France, Germany and the UK. Inflectra offers physicians, patients and healthcare systems a more affordable treatment option as well as maintaining similar quality and safety to its reference product - remicade.
Approval was
given to hospira’s inflectra by the EC subsequent to the safety, efficiency and
tolerability of the data collected from a comprehensive clinical trial
programme. In the study, 73.4% of patients receiving Inflectra achieved a
greater than or equal to 20% improvement in RA symptoms after 30 weeks of
treatment (measured using the ACR20 scoring system), compared with 69.7%
treated with remicade.
New product launches within the biotech sector indicates that
competition has become increasingly intense. To find out more about this
thriving sector please see: Global Pharmaceutical and Biotechnology Outlook 2014: Mature Biotech.
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