Assessing Biosimilarity
UNDERSTANDING BIOLOGICS Introducing Biologics & Biosimilars
UNDERSTANDING BIOLOGICS Introducing Biologics & Biosimilars

Biologics include a wide range of treatments such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. They can be used to treat a variety of medical conditions for which no other treatments are available.1

BIOLOGICS ARE COMPLEX, WITH DISTINCT DIFFERENCES COMPARED WITH SMALL MOLECULES

Unlike small molecules, which are usually chemically derived and have simple, well-defined structures, biologics are typically large, complex, and less easily characterized.1,2 Some biologics consist of simple peptides and many, such as monoclonal antibodies, are much larger and more complex.3

What Are Biosimilars?

The Potential of Biosimilars

References:
1. US FDA. What are “biologics” questions and answers. http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cber/ucm133077.htm. Accessed June 3, 2016. 2. Siegel J. Biosimilars in rheumatology. In: Hochberg MC, Silman AJ, Smolen JS, Weinblatt ME, Weisman MH, eds. Rheumatology. 6th ed. Philadelphia, PA: Elsevier Mosby; 2015:522-529. 3. Berkowitz SA, Engen JR, Mazzeo JR, et al. Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars. Nat Rev Drug Discov. 2012;11:527–540. 4. Shutterstock images. 5. National Center for Biotechnology Information. Aspirin. https://pubchem.ncbi.nlm.nih.gov/compound/aspirin#section=2D-Structure. Accessed June 3, 2016. 6. Synagis (palivizumab). Prescribing Information. AstraZeneca. 2016. 7. Genazzani AA, Biggio G, Caputi AP, et al. Biosimilar drugs: concerns and opportunities. Biodrugs. 2007;21:351–356. 8. Kuhlman M, Covic A. The protein science of biosimilars. Nephrol Dial Transplant. 2006;21[suppl5]:v4–v8. 9. US FDA. Quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product. http://www. fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291134.pdf. Published April 2015. Accessed June 3, 2016. 10. US FDA. Generic drugs: questions and answers. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm100100.htm. Accessed June 3, 2016. 11. US FDA. Scientific considerations in demonstrating biosimilarity to a reference product. http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. Published April 2015. Accessed June 3, 2016. 12. Title VII—Improving Access to Innovative Medical Therapies. Subtitle A—Biologics Price Competition and Innovation. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ucm216146.pdf. Accessed June 3, 2016. 13. US FDA. From our perspective. Biosimilar product labeling. http://www.fda.gov/Drugs/NewsEvents/ucm493240.htm. Accessed June 3, 2016. 14. Generics and Biosimilars Initiative. Biosimilars approved in Canada. http://www.gabionline.net/Biosimilars/General/Subsequent-entry-biologics-approved-in-Canada. Accessed May 3, 2016. 15. Generics and Biosimilars Initiative. Biosimilars approved in the US. http://www.gabionline.net/ Biosimilars/General/Biosimilars-approved-in-the-US. Accessed May 3, 2016. 16. Generics and Biosimilars Initiative. Similar biotherapeutic products approved and marketed in Latin America. http://www.gabionline.net/Biosimilars/General/Similar-biotherapeutic-products-approved-and-marketed-in-Latin-America. Accessed May 3, 2016. 17. Generics and Biosimilars Initiative. Biosimilars approved in Europe. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe. Accessed May 3, 2016. 18. Generics and Biosimilars Initiative. Trastuzumab non-originator biological approved in Russia. http://www.gabionline.net/Biosimilars/News/Trastuzumab-non-originator-biological-approved-in-Russia. Accessed May 3, 2016. 19. Generics and Biosimilars Initiative. Iran approves its first rituximab biogeneric. http://www.gabionline.net/Biosimilars/News/Iran-approves-its-first-rituximab-biogeneric. Accessed May 3, 2016. 20. Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India. http://www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India. Accessed May 3, 2016. 21. Generics and Biosimilars Initiative. Biosimilars approved in South Korea. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-South-Korea. Accessed May 3, 2016. 22. Generics and Biosimilars Initiative. Biosimilars approved in Japan. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Japan. Accessed May 3, 2016. 23. Generics and Biosimilars Initiative. Biosimilars approved in Australia. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Australia. Accessed May 3, 2016. 24. Generics and Biosimilars Initiative. Biosimilars approved in New Zealand. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-New-Zealand. Accessed May 3, 2016. 25. IMS Health. The impact of biosimilar competition. http://ec.europa.eu/DocsRoom/documents/14547/attachments/1/translations/en/renditions/native. Published November 2015. Accessed June 3, 2016. 26. IMS Health. The impact of biosimilar competition–five observations by IMS Health. http://ec.euopa.eu/DocsRoom/documents/14548/attachments/1/translations/en/renditions/native. Accessed June 3, 2016.