HERE’S THE CLARIFICATION YOU ASKED FOR:
What are biosimilars and how do they relate to biologics?
Biological products include a wide range of treatments such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.1 Biosimilars are a new step in biologic medicines and are highly similar to originator (also known as “reference”) biological products, notwithstanding minor differences in clinically inactive components.2,3 Biosimilars are approved using a pathway created by the US Biologics Price Competition and Innovation Act of 2009.4 The goals of creating an abbreviated approval pathway for biosimilars were to increase treatment options and reduce health care costs.5,6
Click to learn more Tap to learn more
How is biosimilarity established?
In evaluating biosimilars, the US Food and Drug Administration (FDA) considers a “Totality-of-the-Evidence” approach.5 Extensive analytical testing of structure and function serve as the foundation of this approach.5 Selective and targeted animal and human clinical studies support that there are no clinically meaningful differences between the biosimilar and the originator biologic.5
Click to learn more Tap to learn more
How is the quality of biosimilars assessed?
Quality should be built in by design using a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product understanding and process control.7
Click to learn more Tap to learn more
What extra information about biosimilars is available?
Merck offers downloadable resources to help further clarifiy biosimilars. Topics include how biosimilars are made, assessed, and used.
Click to learn more Tap to learn more
How does Merck demonstrate its commitment to biosimilars?
Merck has partnered with Samsung Bioepis–combining our individual strengths with a shared commitment to improve human health to deliver consistent, high-quality, affordable biosimilars.8
Click to learn more Tap to learn more

 

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. 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. 3. US FDA. Overview of the regulatory guidance for the development and approval of biosimilar products in the US. http://www.fda.gov/downloads/Advisory Committees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM431118.pdf. Accessed June 3, 2016. 4. 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. 5. 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. 6. US FDA. From our perspective. Biosimilar product labeling. http://www.fda.gov/Drugs/NewsEvents/ucm493240.htm. Accessed June 3, 2016. 7. US FDA. Guidance for Industry. Q8(R2) Pharmaceutical Development. http://www.fda.gov/downloads/Drugs/.../Guidances/ucm073507.pdf. Published November 2009. Accessed June 3, 2016. 8. Samsung Bioepis. Samsung Bioepis and MSD enter biosimilars development and commercialization agreement. http://www.samsungbioepis.com/newsroom2/newsroom_3.html. Accessed May 3, 2016.

Copyright © 2016 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., based in Kenilworth, NJ, USA. This site is intended only for residents of the United States. All rights reserved.     BIOS-1187019-0011     12/16
TRUSTe
TRUSTe
Copyright © 2016 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., based in Kenilworth, NJ, USA. This site is intended only for residents of the United States. All rights reserved.     BIOS-1187019-0010     11/16
TRUSTe
TRUSTe
Copyright © 2016 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., based in Kenilworth, NJ, USA. This site is intended only for residents of the United States. All rights reserved.     BIOS-1193991-0000     09/16
TRUSTe
TRUSTe
Copyright © 2016 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., based in Kenilworth, NJ, USA. This site is intended only for residents of the United States. All rights reserved.     BIOS-1194468-0000     11/16
TRUSTe
TRUSTe
Copyright © 2016 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., based in Kenilworth, NJ, USA. This site is intended only for residents of the United States. All rights reserved.     BIOS-1187019-0008     12/16
TRUSTe
TRUSTe
Copyright © 2016 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., based in Kenilworth, NJ, USA. This site is intended only for residents of the United States. All rights reserved.     BIOS-1187019-0009     12/16
TRUSTe
TRUSTe