What are Biosimilars

What are Biosimilars?

A biosimilar is a successor to a biological medicine (also known as “reference medicine”) for which the patent has expired and exclusivity has been lost.1,2 Biosimilars match their respective reference medicine in terms of quality, safety and efficacy. Hence, the biosimilar can be expected to behave in the same way as the reference medicine in all indications and patient populations that the reference medicines are approved in. Biosimilars are used in the treatment and prevention of many disabling and life-threatening disease areas such as, oncology, rheumatology, dermatology and endocrinology.

Why are Biosimilars Needed?

The introduction of affordable, quality-assured biosimilars can expand access to potentially life-changing medicines for patients worldwide. Biosimilars introduce competition, which leads to innovation such as enhancements of existing medicines and development of new treatments which can benefit patients. 

Biosimilars increase patient access to affordable biologics, firstly it can cause healthcare providers to reassess existing guidance for use for a particular biologic based on considerations around cost-effectiveness. For some healthcare systems it means that patients may be able to access a biologic for their condition for the first time. 

Also, it will enable physicians to access biologics at an earlier stage of the treatment pathway, which can improve outcomes for patients.3

Our healthcare systems are under pressure with growing populations to treat, biosimilars are one way that supports sustainability of healthcare. They enable healthcare systems to redirect funds so more patients can be treated. Additionally, healthcare systems can release resources to help keep pace with growing healthcare needs and fund new generation of innovative treatments so that access to treatments, patient care and patients’ lives can all be improved with a sustainable approach. 

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  1. Weise M, et al. Biosimilars: what clinicians should know. Blood 2012;120:5111-7.
  2. Kay J. A ‘wind of change’ to biosimilars: the NOR-SWITCH trial and its extension. J Intern Med. 2019;285:693-5.
  3. National Institute for Health and Care Excellence. NICE recommends several treatment options to help thousands with moderate rheumatoid arthritis. June 2021. Available from: NICE recommends several treatment options to help thousands with moderate rheumatoid arthritis | News and features | News | NICE [Accessed March 2022]