Biologic medicines are produced by a complex process involving living organisms. They have revolutionised the treatment of many disabling and life-threatening diseases: diabetes, psoriasis, rheumatoid arthritis, growth disorders, inflammatory digestive disorders and certain types of cancer. Many of the medicines used in the NHS today are biologic medicines. Biologics are much larger molecules than the chemically-synthesised small molecule medicines that still represent the majority of medicines.
A biosimilar is an approved biologic with comparable quality, safety and efficacy to an approved reference product. They are approved via stringent regulatory pathways (in highly regulated markets such as the EU, US, Japan, Canada and Australia) following loss of exclusivity of their originator reference products.
A biosimilar must be so similar to the reference biologic that statistically-speaking you cannot tell the two apart in terms of ability to treat the disease (efficacy), safety profile and overall quality. Biosimilars are expected to provide the same clinical benefits as the originator biologic.
Biosimilar medicines have the potential to address patient access challenges, generate cost savings for healthcare systems and increase treatment options for healthcare professionals (HCPs).
Sandoz is a biosimilars pioneer with the first approved biosimilar in both Europe and the US and is a global biosimilars leader with a significant global market share. All Sandoz biosimilars in the EU are approved centrally by the European Medicines Agency (EMA) and are closely monitored through the Sandoz Global Pharmacovigilance System.
As a division of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialisation.
Sandoz has pioneered the use of biosimilars in the NHS, working with European and UK regulatory authorities to develop regulatory pathways and grow understanding of these medicines in patient care.