Steeped in Biologics Experience | Amgen Biosimilars
CLEAR

Clinical Testing

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Proven biosimilarity based on proven science

Amgen generates robust and rigorous data on each biosimilar. Over several years of testing, we collect data to prove biosimilarity for regulatory approval.
A comprehensive comparison of the quality attributes of the biosimilar with the reference product supports that the products are biosimilar on a structural and functional level.1,2 On top of analytical data, the biosimilar can only be approved with additional nonclinical and clinical data.1

Biosimilar development1,3

Demonstrate no clinically meaningful differences in safety and effectiveness in one or more appropriate conditions of use for which the reference product is licensed.

Reference product development3
Demonstrate safety and effectiveness in each condition of use with adequate, well-controlled, substantial evidence for a new product.
Reference product development3
Demonstrate safety and effectiveness in each condition of use with adequate, well-controlled, substantial evidence for a new product.

Biosimilar development1,3

Demonstrate no clinically meaningful differences in safety and effectiveness in one or more appropriate conditions of use for which the reference product is licensed.

Together, the above data make up the totality of evidence for the assessment of biosimilarity.1

"Totality of evidence determines biosimilarity"

References: 1. US Food and Drug Administration. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product. www.fda.gov/downloads/drugs/guidances/ucm291128.pdf. Accessed October 29, 2019. 2. Conner J, Wuchterl D, Lopez M, et al. The biomanufacturing of biotechnology products. In: Shimasaki C, ed. Biotechnology Entrepreneurship: Starting, Managing, and Leading Biotech Companies. Waltham, MA: Academic Press; 2014:351-385. 3. Blauvelt A, Puig L, Chimenti S, et al. Biosimilars for psoriasis: clinical studies to determine similarity. Br J Dermatol. 2017;177:23-33.

HK-09628-AMGEN-2022-Dec
Date of Approval: Dec 2022
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