Biologics are large-molecule drugs, derived from a biological source, that treat chronic diseases such as cancer and autoimmune disorders. While small-molecule compounds continue to account for the bulk of pharmaceutical profits, biologics’ presence is growing.
As the original biologics patents expire, biosimilars are entering the market. This is not only an opening for manufacturers, it also provides cost savings and increased choice for payers, physicians, and patients.
Firsts
2006: Omnitrope, human growth hormone (somatropin) used to treat growth deficiency in children and adults, is the first approved biosimilar in Europe.
2013: Infliximab is the first monoclonal antibody biosimilar approved in Europe.
2015: Zarxio (filgrastim-sndz), a treatment for neutropenia associated with chemotherapy, is the first biosimilar approved by the FDA.
2017: Mvasi (bevacizumabawwb), the first biosimilar for the treatment of multiple cancer types, is approved by the FDA.
Market Share
72% Average European market share for first-to-market biosimilars
$60M Potential health care savings for biosimilars in the US and five major EU markets by 2020
50 Biosimilars in development and likely to enter the market within five years
$50B Current sales of biologics for which biosimilars are expected to enter European market by 2020
57% Annual rate of biosimilars growth expected in the United States over the next five years.
Sources
European Medicines Agency. European Public Assessment Reports. Browse by Type. “Biosimilars.”
Grand View Research. “Biosimilars Market Projected to Reach $41.7 Billion by 2024.” Press release, June 2016.
IMS Institute for Healthcare Informatics. “Delivering on the Potential of Biosimilar Medicines.” IMS Institute for Healthcare Informatics. March 2016.
Mavroudis-Chocholis, Orestis. “The US Biosimilar Market: Where Is It Today, and Where Is It Going?” Biosimilar Development, July 13, 2017.
Mordor Intelligence. “Biosimilar Market—Growth, Trends, and Forecast (2017–2022).
Quintiles IMS. “The Impact of Biosimilar Competition in Europe.” May 2017.
Rovira, Joan, at al. “The Impact of Biosimilars’ Entry in the EU Market.” Andalusian School of Public Health, EMINet, January 2011
Simoens, S., et al. “Assessing the Value of Biosimilars: A Review of the Role of Budget Impact Analysis.” Pharmacoeconomics 35, no. 10 (2017): 1047–1062.
Scott Fotheringham, PhD, is a freelance medical writer with interests that span fields as diverse as medical cannabis, pharmaceuticals, biotechnology, and molecular genetics. Most recently...
The expected FDA approval for a Treprostinil dry powder inhaler revealed a need for the manufacturer to expand its warehousing and logistics capabilities to support its growing operations. The company’s senior leadership wanted to ensure this expansion came with as minimal an impact on the environment as possible, so a key priority was to provide a net zero energy facility. With a vision for...
To enable changes across the pharmaceutical industry, sustainability should be included alongside quality, efficacy, and safety when assessing medicines. This article reviews two case studies that cover sustainable pack types and extension of shelf life. With the drive to manage unmet medical need through acceleration of drug development programs, postapproval sustainability variations will...
The imperative for global action to tackle climate change is clear and the pharmaceutical industry has a key role to play. Governments have entered into international commitments to reduce climate impact (carbon emissions) and protect nature (water, land, air, and biodiversity) with policy frameworks established to facilitate and drive progress against agreed targets.1
