Biological medicines are proteins that are made using living systems such as animal cells and bacteria. As with other types of medicine, a new and original biological medicine has a regulated period of time during which it can be made available exclusively.
Once this period is over, it becomes possible to develop and bring to market a biosimilar medicine of the original or ‘reference’ medicine. The European Medicines Agency defines a biosimilar as a biological medicine highly similar to another already approved biological medicine (the reference medicine). Approved biosimilars have been through rigorous testing to show that they have no clinically meaningful differences from their reference medicines. They are also manufactured to the same meticulous standards to ensure consistent quality.
Where biosimilars differ from their reference medicines, however, is that they typically cost less. This gives them the potential to offer significant savings for healthcare systems globally. For example, according to research by the IMS Institute for Healthcare , biosimilars have the potential to save European healthcare systems around €15 billion in the four years between 2016 and 20201.
The Mundipharma network of independent associated companies has already launched two European-approved biosimilar medicines. We will continue to build our biosimilar portfolio in the coming years to help people living with debilitating and life-threatening diseases, such as rheumatoid arthritis, psoriasis, diabetes and cancer, together with those healthcare systems that support them.
Please note that the medicines mentioned may not be available in all countries. Additionally, currently approved indications and presentations may differ between countries. Please always ask a healthcare professional for advice regarding medicines and refer to individual countries for full product indication and local prescribing information.
Remsima® (infliximab) is a biosimilar approved for the same therapy areas as the reference infliximab: rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease and paediatric Crohn’s disease, ulcerative colitis and pediatric ulcerative colitis, psoriasis, and psoriatic arthritis.
Truxima® (rituximab) is approved for the same therapy areas as the reference rituximab: non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.
Herzuma® (trastuzumab) is a biosimilar approved for the same therapy areas as the intravenous reference trastuzumab; for HER2-positive early breast cancer in the neo-adjuvant and adjuvant setting, metastatic breast cancer, and metastatic gastric cancer in adults.
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