Insight into Biosimilars: Short Description, Analytical Assessment and Market
Main Article Content
Abstract
The World Health Organization (WHO) defines a similar biotherapeutic product, i.e. a biosimilar as a biotherapeutic product that is similar in terms of quality, safety and efficacy to an already licensed reference product on the market (termed as originator or innovator). To ensure similar efficacy and safety, comparability studies for biosimilars should be carried out at quality, preclinical and clinical level.Glycosylation profiles of biosimilars are getting an additional critical quality attribute. The portfolio required for regulatory comparison of identity and release testing has to be assessed with a large number of analytical tests, which are presented here in detail for the example of adalimumab.Adalimumab, as one of the blockbuster drugs and the best-sellingpharmaceutical product world-wide, is analyzed additionally with a competitive field presenting the marketed products or such in development. This competitive field is not surprisingly very crowded. Furthermore, general information about the currently marketed biosimilars includingModeofAction (MoA), clinical indication(s), patent situation, and market situation are shortly summarized for each of the respective originator/biosimilar molecules.As there are not only markets in developed and highly regulated countries, but also in other regions, examples for companies and products in Asia, South and Middle America, and even in Africa are highlighted as well.
Article Details
How to Cite
ZIMMERMANN, Klaus; FIDO, Markus; ROUCKA, Markus.
Insight into Biosimilars: Short Description, Analytical Assessment and Market.
Medical Research Archives, [S.l.], v. 8, n. 3, mar. 2020.
ISSN 2375-1924.
Available at: <https://esmed.org/MRA/mra/article/view/2053>. Date accessed: 26 apr. 2024.
doi: https://doi.org/10.18103/mra.v8i3.2053.
Section
Research Articles
The Medical Research Archives grants authors the right to publish and reproduce the unrevised contribution in whole or in part at any time and in any form for any scholarly non-commercial purpose with the condition that all publications of the contribution include a full citation to the journal as published by the Medical Research Archives.
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5. Vasudevan A, Gibson PR, Van Langenberg DR. Systematic Review: Cost-effective Strategies of Optimizing Anti-tumor Necrosis and Immunomodulators in Inflammatory Bowel Disease. Inflamm Bowel Dis. 2019 Aug 20;25(9):1462-1473. doi: 10.1093/ibd/izy399.
6. Barker J, Girolomoni G, Egeberg A, et al. Anti-TNF biosimilars in psoriasis: from scientific evidence to real-world experience. J Dermatolog Treat. 2019 May 16:1-7. doi: 10.1080/09546634.2019.1610553.
7. Krendyukov A, Schiestl M. Biosimilars in oncology: A decade of experience with granulocyte colony-stimulating factor and its implications for monoclonal antibodies. Crit Rev Oncol Hematol. 2019 Jul 23. pii: S1040-8428(18)30307-X. doi: 10.1016/j.critrevonc.2019.07.009.
8. Barbier L, Declerck P, Simoens S, et al. The arrival of biosimilar monoclonal antibodies in oncology: clinical studies for trastuzumab biosimilars. Br J Cancer. 2019 Jul;121(3):199-210. doi: 10.1038/s41416-019-0480-z.
9. Migliavacca Zucchetti B, Nicolò E, Curigliano G. Biosimilars for breast cancer. Expert Opin Biol Ther. 2019 Jul 10:1-7. doi: 10.1080/14712598.2019.1638362.
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15. Chow SC, Song F, Bai H. Analytical Similarity Assessment in Biosimilar Studies. AAPS J. 2016;18(3):670-7. doi: 10.1208/s12248-016-9882-5.
16. FDA homepage. October 2017. https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm290967.htm.
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18. Wolff-Holz E, Tiitso K, Vleminckx C, Weise M. Evolution of the EU Biosimilar Framework: Past and Future. BioDrugs. 2019 Dec;33(6):621-634. doi: 10.1007/s40259-019-00377-y.
19. Kabir ER, Moreino SS, Sharif Siam MK. The Breakthrough of Biosimilars: A Twist in the Narrative of Biological Therapy. Biomolecules. 2019 Aug 24;9(9). pii: E410. doi: 10.3390/biom9090410.
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