Biosimilars Knowledge Connect

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Join QuintilesIMS biosimilar investigator network to improve access to biologics for patients around the world

Biologics – significant clinical benefit but unaffordable for many.

Since their introduction in the early 1990s, biologic medicines have transformed the therapeutic landscape in many areas of healthcare. Biologics are increasingly recognized for their ability to treat complex and challenging diseases including cancer, autoimmune disorders and diabetes. As a result, seven out of ten of the world’s top-selling medicines are now biologics1 and they are forecast to account for more than 70% of new drug approvals by 2025.2 However, the high cost of biologics puts them out of reach of patients in many countries. The situation is becoming unsustainable for even the most developed nations.

Biosimilars – highly similar, more affordable successors to originator biologics

Biosimilars are closely matched successors to off-patent biologics and offer more cost-effective versions of their branded originators. After many years of patent protection, a number of leading biologics have reached, or will soon be reaching, patent expiry. As such, biosimilars are estimated to comprise about 60% of the total biologics pipeline.3 First approved in Europe in 2006, biosimilars have now been in use for over a decade with no safety or efficacy concerns compared with originators4 and are now supported by a growing body of real-world evidence.

Clinical trials – needed for regulatory approval of biosimilars

Clinical trials are needed to bring these vitally important medications to market. To meet the demand, QuintilesIMS encourages investigators to explore our website for answers to commonly asked questions and register their [your] interest in participation.

References   +

1. The top 25 best-selling drugs of 2013. Genetic Engineering & Biotechnology News, 3 March 2014. Accessed 16 September 2014.
2. Berkowitz SA, Engen JR, Mazzeo JR & Jones GB. Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars. Nat Rev Drug Discov (2012) 11:527–540.
3. Biosimilars/biobetters pipeline database 2014. Accessed 19 November 2014.
4. European Medicines Agency, 5 May 2017. Press release. New guide on biosimilar medicines for healthcare professionals. Accessed 27 June 2017.