Biosimilar medicinal products (biosimilars) have become a reality in the European Union and will soon be available in the United States. Despite an established legal pathway for biosimilars in the European Union since 2005 and increasing and detailed regulatory guidance on data requirements for their development and licensing, many clinicians, particularly oncologists, are reluctant to consider biosimilars as a treatment option for their patients.1
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.1
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 2020.2
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.
- Weise M, Bielsky MC, De Smet K, et al. Biosimilars: what clinicians should know. Blood. 2012;120(26):5111-5117. doi:10.1182/blood-2012-04-425744