There is a lot of information out there about biosimilars. At Merck, we want to bring clarity to that information. We want to create a place for patients and caregivers to get the information they want and need. We believe that the more patients know, the more they can be in charge of their health. This Web site is here to help answer your questions, which is why we chose a question-and-answer format. To explore a topic, please select a question. For additional information, just click the links.
There is a lot of information out there about biosimilars. At Merck, we want to bring clarity to that information. We want to create a place for patients and caregivers to get the information they want and need. We believe that the more patients know, the more they can be in charge of their health. This Web site is here to help answer your questions, which is why we chose a question-and-answer format. To explore a topic, please select a question. For additional information, just tap the links.
HERE’S THE CLARIFICATION YOU ASKED FOR:
What is a biologic medicine?
Biologic medicines can be used to treat conditions such as rheumatoid arthritis, anemia, low white blood cell counts, inflammatory bowel disease, skin conditions such as psoriasis, and various forms of cancer.1 Biologic medicines are made from living organisms.1 These include both human and animal cells, and microorganisms such as bacteria or yeast.1
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What are biosimilars?
Biosimilars are a type of biologic medicine. They work in a similar way to an already approved biologic medicine. The biologic medicine that has already been approved by the Food and Drug Administration (FDA) is known as the originator biologic or reference product.2,3
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Are biosimilars safe and effective?
The Food and Drug Administration (FDA) requires proof that all medications are safe and effective before they are made available to patients. They ensure this by asking for many types of scientific and clinical tests. Since biosimilars are approved by the FDA, they go through all these tests. Merck’s approach to developing safe and effective biosimilars includes 3 phases: create, confirm, and control.3-5
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What is the value in using a biosimilar? What is the value in using a biosimilar?
Biosimilars offer safe and effective treatment options for patients. They may help reduce health care spending.6 They also have the potential to help increase patient access to biologic medicines.7
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Will there be support for patients starting on biosimilars?
Many people who need biosimilars also need support to help them manage their treatment. Support is offered by the makers of biosimilars and can vary by maker.
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References:
1. US FDA. Information for consumers (Biosimilars). http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm241718.htm. Accessed June 24, 2016. 2. US FDA. Biosimilar biological products. http://www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM365448.pdf. Accessed June 24, 2016. 3. 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. 4. FDA. Guidance for industry. Q8(R2) Pharmaceutical Development. http://www.fda.gov/downloads/Drugs/.../Guidances/ucm073507.pdf. Published November 2009. 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. Scientific considerations in demonstrating biosimilarity to a reference product. http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. Published April 2015. Accessed July 26, 2016. 7. US FDA. From our perspective. Biosimilar product labeling. http://www.fda.gov/Drugs/NewsEvents/ucm493240.htm. Accessed June 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
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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
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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
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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
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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
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