Abasaglar ® (basal insulin glargine)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Abasaglar Summary of Product Characteristics (SmPC)

Abasaglar® (insulin glargine): Batch-to-Batch Variability

Biologic products manufactured through the complex multistep biotechnology processes are subject to variability.

Source of Variability

Products such are insulins, which are products of fermentation or purification performed in batches, might display batch-to-batch variability.1

Regulatory Authorities - Batch Control

Variability is strictly controlled by the regulatory authorities (FDA/EMA).2,3

Lilly complies with requirements of regulatory authorities and has strategies in place to ensure continuous consistency of its products.4

References

1. Kuhlmann MK, Schmidt A. Production and manufacturing of biosimilar insulins: implications for patients, physicians,and health care systems. Biosimilars 2014:4 45–58. http://dx.doi.org/10.2147/BS.S36043

2. US Food and Drug Administration. Current good manufacturing practice for finished pharmaceuticals. 21 CFR 211. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211&showFR=1&subpartNode=21:4.0.1.1.11.10. Revised April 1, 2017. Accessed June 21, 2018.

3. European Medicines Agency. Internationally harmonised requirements for batch certification. EMA/INS/MRA/387218/2011 Rev 5. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/mra_batch-certificate_05-2011.pdf. Revised May 24, 2011. Accessed June 21, 2018.

4. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Date of Last Review: June 15, 2018

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