Abasaglar ® (insulin glargin)

För fullständig produktresumé för Abasaglar® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Abasaglar® (insulin glargin): Batchvariabilitet

Biologiska produkter som tillverkas genom komplexa bioteknologiska flerstegsprocesser är föremål för variationer.

Detailed Information

Biologic products manufactured through the complex multistep biotechnology processes are subject to variability.1,2

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).3,4

Lilly complies with requirements of regulatory authorities and has strategies in place to ensure continuous consistency of its products.5

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. Heinemann L. Biosimilar insulins. Expert Opin Biol Ther. 2012;12(8):1009-1016. http://dx.doi.org/10.1517/14712598.2012.688024

3. 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.

4. 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.

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

Glossary

EMA = European Medicines Agency

FDA = U.S. Food and Drug Administration

Lilly = Eli Lilly and Company

Datum fӧr senaste ӧversyn 2018 M06 15


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