Demonstration of functional similarity of a biosimilar adalimumab SB5 to Humira®.
@article{Lee2019DemonstrationOF, title={Demonstration of functional similarity of a biosimilar adalimumab SB5 to Humira®.}, author={J. J. Lee and Junmo Yang and C. Lee and Youngjin Moon and S. Ahn and Jiyoon Yang}, journal={Biologicals : journal of the International Association of Biological Standardization}, year={2019}, volume={58}, pages={ 7-15 } }
A biosimilar is a biological medicinal product that is highly similar to an authorized biological product in terms of quality, biological activity, safety and efficacy. SB5 was developed by Samsung Bioepis as a biosimilar referencing adalimumab, and was authorized by the European Commission (EC) in August 2017 (Imraldi®). Extensive characterization studies were performed to demonstrate functional similarity of SB5 to reference adalimumab (Humira®, AbbVie Inc. and AbbVie Deutschland GmbH & Co… CONTINUE READING
Topics from this paper
4 Citations
SB5 shows cross-immunogenicity to adalimumab but not infliximab: results in patients with inflammatory bowel disease or rheumatoid arthritis
- Medicine
- Therapeutic advances in gastroenterology
- 2019
- 5
Reporting of quality attributes in scientific publications presenting biosimilarity assessments of (intended) biosimilars: a systematic literature review.
- Medicine
- European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences
- 2020
References
SHOWING 1-10 OF 22 REFERENCES
Developing the Totality of Evidence for Biosimilars: Regulatory Considerations and Building Confidence for the Healthcare Community
- Medicine
- BioDrugs
- 2017
- 49
- PDF
Differences in binding and effector functions between classes of TNF antagonists.
- Biology, Medicine
- Cytokine
- 2009
- 102
Considerations in the early development of biosimilar products.
- Medicine
- Drug discovery today
- 2015
- 24
- PDF
Fc glycans of therapeutic antibodies as critical quality attributes
- Biology, Medicine
- Glycobiology
- 2015
- 190
- PDF
Anti-tumor necrosis factor-α antibodies induce regulatory macrophages in an Fc region-dependent manner.
- Biology, Medicine
- Gastroenterology
- 2011
- 146
Mechanisms for cytotoxic effects of anti-tumor necrosis factor agents on transmembrane tumor necrosis factor alpha-expressing cells: comparison among infliximab, etanercept, and adalimumab.
- Medicine
- Arthritis and rheumatism
- 2008
- 303
Importance of Neonatal FcR in Regulating the Serum Half-Life of Therapeutic Proteins Containing the Fc Domain of Human IgG1: A Comparative Study of the Affinity of Monoclonal Antibodies and Fc-Fusion Proteins to Human Neonatal FcR
- Biology, Medicine
- The Journal of Immunology
- 2010
- 239
- PDF
Mechanisms of Action of Anti–tumor Necrosis Factor &agr; Agents in Crohn’s Disease
- Medicine
- Inflammatory bowel diseases
- 2013
- 47