A biological medicine (commonly referred to as a “biologic” or “biopharmaceutical”) is a pharmaceutical drug whose active substance is made by or extracted from living organisms, tissues, or cells.1
Biologic medicines have revolutionized the management of some of the most hard-to-treat diseases (cancer, anemia, and autoimmune conditions such as multiple sclerosis, rheumatoid arthritis, psoriasis, and inflammatory bowel disease).1
However, as developing and supplying these medicines is complex, biologics are contributing to the rising cost of healthcare, and this may restrict patient access to potentially life-saving treatments.2
The prospect of more affordable options that match the reference medicines in terms of safety, efficacy, and quality creates opportunities for healthcare systems to expand access to biologics for more patients, free up resources for investment in new areas, and relieve pressured healthcare budgets.
A biosimilar is a successor to a biologic medicine (also known as ‘reference medicine’) for which the patent has expired and exclusivity has been lost3,4.
To be approved for use, a biosimilar must match the reference medicine in terms of safety, efficacy, and quality. Therefore, physicians and patients can expect the same clinical outcome.4 This is based on the “totality of evidence” concept using comparative analytical and functional assays.5,6
Find out more about the Development of Biosimilars here.
With suitable policies and systems implemented by countries’ healthcare authorities, biosimilars have the potential to improve access challenges faced by patients, generate cost savings for healthcare systems and increase treatment options for healthcare professionals.