Next Generation Biologics Manufacturing | Amgen Biosimilars
CLEAR

Manufacturing

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Our process is what defines us

At Amgen, we excel at the highly specialized, iterative process of developing monoclonal antibodies in vitro, scaling up the optimal cell line, time and again, in large-scale bioreactors, and checking and rechecking for batch-to-batch consistency.4,5

End-to-end biologics experts: our process4

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Medicines born of living cells

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Biosimilars are not generics

BioEngage
Biosimilars are not generics

Differences between generics and biosimilars:

  • A generic drug, by definition, is an exact copy of its reference medicine.3
  • A generic must have the same chemical structure as its reference product and takes an average of 3-5 years to develop. Each biosimilar requires additional evidence beyond that needed for a generic to prove similarity, and takes an average of 8-10 years to develop.3-5
  • Whereas generics require approximately 50 quality assurance tests as part of the manufacturing process, biologics, including biosimilars, are complex and can require approximately 250 tests to ensure potency, purity, and quality.6
  • Unlike a generic, a biosimilar will not be identical to its reference product.3
  • Biosimilars are "highly similar" with no clinically meaningful differences to—but not identical copies of—their reference biologic.3

Our biologic medicines are manufactured using living cells engineered to produce therapeutic proteins in large quantities. Those cells are very sensitive to conditions produced during their synthesis and handling, and a series of culturing and purification steps are required to produce a consistent, quality active ingredient.9

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The complexities of biosimilar manufacturing

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The complexities of biosimilar manufacturing

BioEngage
The complexities of biosimilar manufacturing
When manufacturing a biosimilar, only the reference product’s amino acid sequence is known. From there, the biosimilar candidate requires considerable preclinical optimization.2

All of the complexities of manufacturing innovator biologics apply to biosimilar medicines as well. But biosimilar creation also has its own set of intricacies.

References: 1. Kozlowski S. US FDA perspectives on biosimilar biological products. Presented at: 2014 Biotechnology Technology Summit; June 13, 2014; Rockville, MD. www.ibbr.umd.edu/sites/default/files/public_page/Kozlowski%20-%20Biomanufacturing%20Summit.pdf. Accessed October 29, 2019. 2. US Food and Drug Administration. Guidance for industry: quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product. www.fda.gov/downloads/drugs/guidances/ucm291134.pdf. Accessed October 29, 2019. 3. 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. 4. Desanvicente-Celis Z, Gomez-Lopez A, Anaya JM. Similar biotherapeutic products: overview and reflections. Immunotherapy. 2012;4:1841-1857. 5. Ramanan S, Grampp G. Drift, evolution, and divergence in biologics and biosimilars manufacturing. BioDrugs. 2014;28:363-372. 6. Bee JS, Randolph TW, Carpenter JF, Bishop SM, Dimitrova MN. Effects of surfaces and leachables on the stability of biopharmaceuticals. J Pharma Sci. 2011;100:4158-4170. 7. 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. 8. Blauvelt A, Cohen AD, Puig L, Vender R, van der Walt J, Wu JJ. Biosimilars for psoriasis: preclinical analytical assessment to determine similarity. Br J Dermatol. 2016;174:282-286. 9. Lybecker KM. The biologics revolution in the production of drugs. Fraser Institute. www.fraserinstitute.org/studies/biologics-revolution-in-the-production-of-drugs. Accessed October 29, 2019. 10. Dranitsaris G, Amir E, Dorward K. Biosimilars of biological drug therapies. Drugs. 2011;71:1527-1536. 11. Liu HF, Ma J, Winter C, Bayer R. Recovery and purification process development for monoclonal antibody production. mAbs. 2010;2:480-499. 12. Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol. 2008;19:411-419. 13. Roger SD. Biosimilars: how similar or dissimilar are they? Nephrology. 2006;11:341-346. 14. Hesse F, Wagner R. Developments and improvements in the manufacturing of human therapeutics with mammalian cell cultures. Trends Biotechnol. 2000;18:173-180.