Biosimilar Manufacturing | BioEngage from Amgen Biosimilars
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Your source for biosimilars information.
Last updated Nov 2021

The challenge of manufacturing biosimilars

Developing a biosimilar is far more nuanced and complex than developing a generic drug(1). Biosimilars are produced through an intricate, multi-step process, using living cells(2,3).

This manufacturing information for the reference product is proprietary(4,5). The biosimilar manufacturer must therefore develop a new cell line and manufacturing parameters that result in a highly similar product(6).

Read our additional resources below for more information on the manufacturing process.

quality

Feature

Critical Quality Attributes

reliable

Viewpoint

Reliable Supply Is Crucial for Health Care Systems
complexities

Viewpoint

The Complexities of Biosimilars Development
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Topic in Depth

Developing Biosimilars: the Process and Quality Standards
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Feature

Ensuring a Robust Raw Materials Supply Chain
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Topic in Depth

Preventing Shortages of Biologic Medicines
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Video

Pharmacists Discuss Drug Shortages

complexitybio

Video

Monoclonal Antibody Complexity and Biosimilar Manufacturing

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Scientific Study

Managing Unexpected Events in the Manufacturing of Biologic Medicines

considerations

Topic in Depth

The Importance of Analytical Characterization in Biosimilar Development

References: 1. United States Food and Drug Administration. Generic Drug Facts. 2018. 2. Desanvicente-Celis. Immunotherapy. 2012. 1843-B-2; 1844-A-1i 3. Dranitsaris. Drugs. 2011. 1527-B-1; 1528-Figure 1 4. Lee JF, Litten JB, Grampp G. Comparability and biosimilarity: considerations for the healthcare provider. Curr Med Res Opin. 2012;28:1053-1058 5. Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol. 2008;19:411-419. 6. United States Food and Drug Administration. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. 2015.