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): Biosimilaritet kontra bioekvivalens

Biosimilar är en offentlig beteckning för liknande versioner av biologiska behandlingar. Bioekvivalens är en farmakokinetisk bedömning av dessa läkemedel.

Biosimilarity

Biological treatments that are approved through biosimilar pathways may be defined by governing regulatory bodies as biosimilar.1

European Medicines Agency

The EMA defines a biological medicinal product as a biosimilar if it contains a version of an active substance of an already authorized original biological medicinal product, also called the reference medicinal product, in the European Economic Area.2

In order to grant approval as a biosimilar product, the EMA requires studies demonstrating similarity of the biosimilar to the reference medicinal product in terms of

  • quality characteristics

  • biological activity

  • efficacy, and

  • safety.2

Bioequivalence

Bioequivalence is a PK term used to assess the expected in vivo biological equivalence of 2 proprietary preparations of a drug.3

Medicinal products are bioequivalent if they both

  • contain the same active ingredient

  • are pharmaceutical equivalents, and

  • have bioavailability demonstrating similar efficacy and safety within acceptable predefined in vivo limits after same molar dose administration.3

If 2 biological products are manufactured by different companies without technology transfer they cannot be said to contain the same active ingredient, and therefore, they cannot be bioequivalent.

References

1. Dolinar R, Lavernia F, Edelman S. A guide to follow-on biologics and biosimilars with a focus on insulin. Endocr Pract. 2018;24(2):195-204. https://doi.org/10.4158/EP161728.RA

2. Committee for Medicinal Products for Human Use (CHMP); European Medicines Agency. Guideline on similar biological medicinal products. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf. Published October 23, 2014. Accessed January 29, 2020.

3. Committee for Medicinal Products for Human Use (CHMP); European Medicines Agency. Guideline on the investigation of bioequivalence. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf. Published January 20, 2010. Accessed January 29, 2020.

Glossary

EMA = European Medicines Agency

PK = pharmacokinetic

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2020 M01 29


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