Examples of the impact that biologicals have had on health care include:

Trastuzumab in human epidermal growth factor receptor 2 positive (HER-2+) breast cancer
Disease recurrences have halved and mortality has reduced by a third

Belimumab in lupus
First treatment advance in 50 years

β-interferons in multiple sclerosis
First disease-modifying therapy; fewer relapses and slowing of disability

Rituximab in non-Hodgkin’s lymphoma
New standard of care, increased survival

Anti-tumour necrosis factor-alpha (anti-TNF-α) in inflammatory bowel disease/Crohn’s disease
Revolutionized care: sustained remissions and reduced need for surgery

Targeted biological therapies in rheumatoid arthritis
Reduction in deformity and remission now a realistic goal

However, despite the great advantages of many biologicals, developing biosimilars of such complicated molecules is not always easy. In the following series of three articles the considerations for real-world research on biosimilars, uptake of biosimilars and the design of biosimilar studies are presented.

Related articles
Designing fit-for-purpose biosimilar studies

Uptake of biosimilars in different countries varies

Considerations for real-world research on biosimilars

Reference
1. Bosco J. Biosimilar considerations for real world research and stakeholder questions. DIA Biosimilars Conference; 2019 Sep 23‒24; Bethesda, Maryland, USA.

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