American Diabetes Association (2021) Pharmacologic approaches to glycemic treatment: standards of medical care in diabetes-2021. Diab Car 44(Suppl 1):111–124. https://doi.org/10.2337/dc21-s009
Handelsman Y, Bloomgarden ZT, Grunberger G, Umpierrez G, Zimmerman RS, Bailey TS et al (2015) American association of clinical endocrinologists and American college of endocrinology—clinical practice guidelines for developing a diabetes mellitus comprehensive care plan. Endocr Pract 21(Suppl 1):1–87. https://doi.org/10.4158/EP15672.GL
Article PubMed PubMed Central Google Scholar
Sanchez-Rangel E, Inzucchi SE (2017) Metformin: clinical use in type 2 diabetes. Diabetologia 60(9):1586–1593. https://doi.org/10.1007/s00125-017-4336-x
Article CAS PubMed Google Scholar
Sansome DJ, Xie C, Veedfald S, Horowitz M, Rayner CK, Wu T (2019) Mechanism of glucose-lowering by metformin in type 2 diabetes: Role of bile acids. Diabetes Obes Metab. https://doi.org/10.1111/dom.13869
Lazzaroni E, Ben Nasr M, Loretelli C, Pastore I, Plebani L, Lunati ME, Vallone L, Bolla AM, Rossi A, Montefusco L, Ippolito E, Berra C, D’Addio F, Zuccotti GV, Fiorina P (2021) Anti-diabetic drugs and weight loss in patients with type 2 diabetes. Pharmacol Res 171:105782. https://doi.org/10.1016/j.phrs.2021.105782
Article CAS PubMed Google Scholar
Mudaliar SR, Lindberg FA, Joyce M, Beerdsen P, Strange P, Lin A, Henry RR (1999) Insulin aspart (B28 asp-insulin): a fast-acting analog of human insulin: absorption kinetics and action profile compared with regular human insulin in healthy nondiabetic subjects. Diab Car 22(9):1501. https://doi.org/10.2337/diacare.22.9.1501
Gao J, Xiong Q, Miao J, Zhang Y, Xia L, Lu M et al (2015) Analysis of alternatives for insulinizing patients to achieve glycemic control and avoid accompanying risks of hypoglycemia. Biomed Rep 3(3):284–288. https://doi.org/10.3892/br.2015.434
Article CAS PubMed PubMed Central Google Scholar
Kjeld H, Mette B, Anne GS (2016) Insulin Aspart in the management of diabetes mellitus: 15 years of clinical experience. Drugs 76:41–74. https://doi.org/10.1007/s40265-015-0500-0
Guideline on similar biological medicinal products, CHMP/437/04 Rev 1. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-rev1_en.pdf. Accessed 23 Oct 2014
Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues, EMEA/CHMP/BMWP/42832/2005 Rev1. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-2.pdf . Accessed 18 Dec 2014
Scientific considerations in demonstrating biosimilarity to a reference product (Guidance for Industry). https://www.fda.gov/media/82647/download. Accessed Apr 2015
Clinical pharmacology data to support a demonstration of biosimilarity to a reference product guidance for industry. https://www.fda.gov/media/88622/download. Accessed Dec 2016.
Mishra AG, Deshmane RB, Thappa DK et al (2023) In vitro biological characterization of recombinant insulin Aspart from biogenomics and originator insulin Aspart. BioDrugs. https://doi.org/10.1007/s40259-023-00607-4
Walsh G, Jefferis R (2006) Post-translational modifications in the context of therapeutic proteins. Nat Biotechnol 24(10):1241–1252. https://doi.org/10.1038/nbt1252
Article CAS PubMed Google Scholar
Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues, EMEA/CHMP/BMWP/42832/2005 Rev1. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-2.pdf. Accessed 18 Dec 2014
Davies M, Dahl D, Heise T, Kiljanski J, Mathieu C (2017) Introduction of biosimilar insulins in Europe. Diabet Med 34(10):1340–1353. https://doi.org/10.1111/dme.13400
Article CAS PubMed PubMed Central Google Scholar
Development of therapeutic protein biosimilars: comparative analytical assessment and other quality-related considerations. https://www.fda.gov/media/125484/download. Accessed May 2019
Groot De, Anne S, Scott DW (2007) Immunogenicity of protein therapeutics. Trends Immunol 28(11):482–490. https://doi.org/10.1016/j.it.2007.07.011.PMID17964218
Baker M, Reynolds HM, Lumicisi B, Bryson CJ (2010) Immunogenicity of protein therapeutics: the key causes, consequences and challenges. Self/Nonself 1(4):314–322. https://doi.org/10.4161/self.1.4.13904.PMC3062386.PMID21487506
Article PubMed PubMed Central Google Scholar
Lindsey BB, Armitage EP, Kampmann B, de Silva TI (2019) The efficacy, effectiveness, and immunogenicity of influenza vaccines in Africa: a systematic review. Lancet Infect Dis 19(4):110–119. https://doi.org/10.1016/S1473-3099(18)30490-0
WHO (2014) WHO Expert Committee on Biological Standardization. World Health Organization. ISBN 978–92–4–069262–6. OCLC 888748977
Shankar G, Pendley C, Stein KE (2007) A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs. Nat Biotechnol 25(5):555–561. https://doi.org/10.1038/nbt1303
Article CAS PubMed Google Scholar
Schellekens H (2005) Factors influencing the immunogenicity of therapeutic proteins. Nephrol Dial Transplant 20(Suppl 6):3–9. https://doi.org/10.1093/ndt/gfh1092
Hoffmann S, Cepok S, Grummel V, Lehmann-Horn K, Hackermüller J, Stadler PF et al (2008) HLA-DRB1*0401 and HLA-DRB1*0408 are strongly associated with the development of antibodies against interferon-beta therapy in multiple sclerosis. Am J Hum Genet 83(2):219–227. https://doi.org/10.1016/j.ajhg.2008.07.006
Article CAS PubMed PubMed Central Google Scholar
Donnelly RP, Dickensheets H, O’Brien TR (2011) Interferon-lambda and therapy for chronic hepatitis C virus infection. Trends Immunol 32(9):443–450. https://doi.org/10.1016/j.it.2011.07.002
Article CAS PubMed PubMed Central Google Scholar
Fineberg SE, Kawabata TT, Finco-Kent D, Fountaine RJ, Finch GL, Krasner AS (2007) Immunological responses to exogenous insulin. Endocr Rev 28(6):625–652. https://doi.org/10.1210/er.2007-0002
Article CAS PubMed Google Scholar
Gupta SK (2011) Implications of ICH-E5: assessment of drug’s sensitivity to ethnic factors and necessity of a bridging study for global drug development. Perspect Clin Res 2(4):121–123. https://doi.org/10.4103/2229-3485.86874
Article PubMed PubMed Central Google Scholar
Shankar G, Arkin S, Cocea L, Devanarayan V, Kirshner S, Kromminga A et al (2014) Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations. AAPSJ 16(4):658–673. https://doi.org/10.1208/s12248-014-9599-2
Article CAS PubMed PubMed Central Google Scholar
Devanarayan V, Smith WC, Brunelle RL, Seger ME, Krug K, Bowsher RR (2017) Recommendations for systematic statistical computation of immunogenicity cut points. AAPS J 19(5):1487–1498. https://doi.org/10.1208/s12248-017-0107-3
Article CAS PubMed Google Scholar
Guideline on Immunogenicity assessment of therapeutic proteins, EMEA/CHMP/BMWP/14327/2006 Rev 1.https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-immunogenicity-assessment-therapeutic-proteins-revision-1_en.pdf. Accessed 18 May 2017
Schellekens H (2008) Recombinant human erythropoietins, biosimilars and immunogenicity. J Nephrol 21(4):497–502
Comments (0)