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Reviews

Biosimilar recombinant follicle stimulating hormones in infertility treatment

& , MD PhD

Bibliography

  • Home PD, Alberti KG. The new insulins. Their characteristics and clinical indications. Drugs 1982;24(5):401-13
  • Johnson IS. Human insulin from recombinant DNA technology. Science (New York, NY) 1983;219(4585):632-7
  • Bliss M. Rewriting medical history: charles Best and the Banting and Best myth. J Hist Med Allied Sci 1993;48(3):253-74
  • Szego CM, White A. The influence of purified growth hormone on fasting metabolism. J Clin Endocrinol Metab 1948;8(7):594
  • Schellekens H. Biosimilar therapeutics-what do we need to consider? NDT Plus 2009;2(Suppl1):i27-36
  • Weise M, Bielsky MC, De Smet K, et al. Biosimilars-why terminology matters. Nat Biotechnol 2011;29(8):690-3
  • Ben-Maimon CS. Point: why biogenerics make sense. Nat Biotechnol 2006;24(3):268-9
  • Covic A, Cannata-Andia J, Cancarini G, et al. Biosimilars and biopharmaceuticals: what the nephrologists need to know--a position paper by the ERA-EDTA Council. Nephrol Dial Transplant 2008;23(12):3731-7
  • Bourgoin A. Business of biosimilars - 14th annual conference (october 15-17, 2013 - Boston, massachusetts, USA). Drugs Today (Barcelona, Spain : 1998) 2013;49(12):799-801
  • Roger SD, Mikhail A. Biosimilars: opportunity or cause for concern? J Pharm Pharm Sci 2007;10(3):405-10
  • Ledford H. ’Biosimilar’ drugs poised to penetrate market. Nature 2010;468(7320):18-19
  • Isaksson R, Tiitinen A. Present concept of unexplained infertility. Gynecol Endocrinol 2004;18(5):278-90
  • Collins J, Crosignani PG. The ESHRE Capri workshop group. Physiopathological determinants of human infertility. Hum Reprod Update 2002;8(5):435-47
  • Steptoe PC, Edwards RG. Birth after the reimplantation of a human embryo. Lancet 1978;2(8085):366
  • Edwards RG. Maturation in vitro of human ovarian oocytes. Lancet 1965;2(7419):926-9
  • Hull MG, Glazener CM, Kelly NJ, et al. Population study of causes, treatment, and outcome of infertility. Br Med J (Clinical research ed) 1985;291(6510):1693-7
  • Hamberger L, Lundin K, Sjogren A, Soderlund B. Indications for intracytoplasmic sperm injection. Hum Reprod (Oxford, England) 1998;13(Suppl 1):128-33
  • Ferraretti AP, Goossens V, Kupka M, et al. Assisted reproductive technology in Europe, 2009: results generated from European registers by ESHRE. Human Reprod (Oxford, England) 2013;28(9):2318-31
  • Buhler K; and the Board of Trustees. Annual 2009 - German IVF-Registry. J Reproduktionsmed Endokrinol 2010;7:470-97
  • Scaravelli G, De Luca R, Bolli S, et al. 6° Report. Attività del registro nazionale italiano della procreazione medicalmente assistita. Istituto Superiore di Sanità, Registro Nazionale della Procreazione Medicalmente Assistita; 2010. p. 1-134
  • De Leo V, Musacchio MC, Di Sabatino A, et al. Present and future of recombinant gonadotropins in reproductive medicine. Curr Pharm Biotechnol 2012;13(3):379-91
  • Rathnam P, Saxena BB. Primary amino acid sequence of follicle-stimulating hormone from human pituitary glands. I. Alpha subunit. J Biol Chem 1975;250(17):6735-46
  • Simoni M, Nieschlag E. FSH in therapy: physiological basis, new preparations and clinical use. Reprod Med Rev 1995;4:163-7
  • Chappel SC, Ulloa-Aguirre A, Coutifaris C. Biosynthesis and secretion of follicle-stimulating hormone. Endocr Rev 1983;4(2):179-211
  • Bousfield GR, Butnev VY, Butnev VY, et al. Hypo-glycosylated human follicle-stimulating hormone (hFSH(21/18)) is much more active in vitro than fully-glycosylated hFSH (hFSH(24)). Mol Cell Endocrinol 2014;382(2):989-97
  • Walton WJ, Nguyen VT, Butnev VY, et al. Characterization of human FSH isoforms reveals a nonglycosylated beta-subunit in addition to the conventional glycosylated beta-subunit. J Clin Endocrinol Metab 2001;86(8):3675-85
  • Padmanabhan V, McFadden K, Mauger DT, et al. Neuroendocrine control of follicle-stimulating hormone (FSH) secretion. I. Direct evidence for separate episodic and basal components of FSH secretion. Endocrinology 1997;138(1):424-32
  • Wide L, Wide M. Higher plasma disappearance rate in the mouse for pituitary follicle-stimulating hormone of young women compared to that of men and elderly women. J Clin Endocrinol Metab 1984;58(3):426-9
  • Morell AG, Gregoriadis G, Scheinberg IH, et al. The role of sialic acid in determining the survival of glycoproteins in the circulation. J Biol Chem 1971;246(5):1461-7
  • Vaitukaitis JL, Ross GT. Altered biologic and immunologic activities of progressively desialylated human urinary FSH. J Clin Endocrinol Metab 1971;33(2):308-11
  • Galway AB, Hsueh AJ, Keene JL, et al. In vitro and in vivo bioactivity of recombinant human follicle-stimulating hormone and partially deglycosylated variants secreted by transfected eukaryotic cell lines. Endocrinology 1990;127(1):93-100
  • Cerpa-Poljak A, Bishop LA, Hort YJ, et al. Isoelectric charge of recombinant human follicle-stimulating hormone isoforms determines receptor affinity and in vitro bioactivity. Endocrinology 1993;132(1):351-6
  • Ashwell G, Harford J. Carbohydrate-specific receptors of the liver. Annu Rev Biochem 1982;51:531-54
  • Blum WF, Gupta D. Heterogeneity of rat FSH by chromatofocusing: studies on serum FSH, hormone released in vitro and metabolic clearance rates of its various forms. J Endocrinol 1985;105(1):29-37
  • Bousfield GR, Butnev VY, Walton WJ, et al. All-or-none N-glycosylation in primate follicle-stimulating hormone beta-subunits. Mol Cell Endocrinol 2007;260-262:40-8
  • Wide L, Albertsson-Wikland K. Change in electrophoretic mobility of human follicle-stimulating hormone in serum after administration of gonadotropin-releasing hormone. J Clin Endocrinol Metab 1990;70(1):271-6
  • Padmanabhan V, Mieher CD, Borondy M, et al. Circulating bioactive follicle-stimulating hormone and less acidic follicle-stimulating hormone isoforms increase during experimental induction of puberty in the female lamb. Endocrinology 1992;131(1):213-20
  • Bassett RM, Driebergen R. Continued improvements in the quality and consistency of follitropin alfa, recombinant human FSH. Reprod Biomed Online 2005;10(2):169-77
  • Keene JL, Matzuk MM, Otani T, et al. Expression of biologically active human follitropin in Chinese hamster ovary cells. J Biol Chem 1989;264(9):4769-75
  • le Cotonnec JY, Porchet HC, Beltrami V, et al. Clinical pharmacology of recombinant human follicle-stimulating hormone (FSH). I. Comparative pharmacokinetics with urinary human FSH. Fertil Steril 1994;61(4):669-78
  • Matikainen T, De Leeuw R, Mannaerts B, Huhtaniemi I. Circulating bioactive and immunoreactive recombinant human follicle stimulating hormone (Org 32489) after administration to gonadotropin-deficient subjects. Fertil Steril 1994;61(1):62-9
  • Mannaerts B, Shoham Z, Schoot D, et al. Single-dose pharmacokinetics and pharmacodynamics of recombinant human follicle-stimulating hormone (Org 32489*) in gonadotropin-deficient volunteers. Fertil Steril 1993;59(1):108-14
  • Bousfield GR, Butnev VY, Bidart JM, et al. Chromatofocusing fails to separate hFSH isoforms on the basis of glycan structure. Biochemistry 2008;47(6):1708-20
  • Olijve W, de Boer W, Mulders JW, van Wezenbeek PM. Molecular biology and biochemistry of human recombinant follicle stimulating hormone (Puregon). Mol Hum Reprod 1996;2(5):371-82
  • Howles CM, Loumaye E, Giroud D, Luyet G. Multiple follicular development and ovarian steroidogenesis following subcutaneous administration of a highly purified urinary FSH preparation in pituitary desensitized women undergoing IVF: a multicentre European phase III study. Hum Reprod (Oxford, England) 1994;9(3):424-30
  • Loumaye E, Campbell R, Salat-Baroux J. Human follicle-stimulating hormone produced by recombinant DNA technology: a review for clinicians. Hum Reprod Update 1995;1(2):188-99
  • Mulders JW, Derksen M, Swolfs A, Maris F. Prediction of the in vivo biological activity of human recombinant follicle stimulating hormone using quantitative isoelectric focusing. Biologicals 1997;25(3):269-81
  • Out HJ, Driessen SG, Mannaerts BM, Coelingh Bennink HJ. Recombinant follicle-stimulating hormone (follitropin beta, Puregon) yields higher pregnancy rates in in vitro fertilization than urinary gonadotropins. Fertil Steril 1997;68(1):138-42
  • Harlin J, Csemiczky G, Wramsby H, Fried G. Recombinant follicle stimulating hormone in in-vitro fertilization treatment-clinical experience with follitropin alpha and follitropin beta. Hum Reprod (Oxford, England) 2000;15(2):239-44
  • Brinsden P, Akagbosu F, Gibbons LM, et al. A comparison of the efficacy and tolerability of two recombinant human follicle-stimulating hormone preparations in patients undergoing in vitro fertilization-embryo transfer. Fertil Steril 2000;73(1):114-16
  • Amoresano A, Siciliano R, Orru S, et al. Structural characterisation of human recombinant glycohormones follitropin, lutropin and choriogonadotropin expressed in Chinese hamster ovary cells. Eur J Biochem 1996;242(3):608-18
  • Ulloa-Aguirre A, Midgley AR Jr, Beitins IZ, Padmanabhan V. Follicle-stimulating isohormones: characterization and physiological relevance. Endocr Rev 1995;16(6):765-87
  • Timossi C, Damian-Matsumura P, Dominguez-Gonzalez A, Ulloa-Aguirre A. A less acidic human follicle-stimulating hormone preparation induces tissue-type plasminogen activator enzyme activity earlier than a predominantly acidic analogue in phenobarbital-blocked pro-oestrous rats. Mol Hum Reprod 1998;4(11):1032-8
  • Lombardi A, Andreozzi C, Pavone V, et al. Evaluation of the oligosaccharide composition of commercial follicle stimulating hormone preparations. Electrophoresis 2013;34(16):2394-406
  • Simoni M, Jockenhovel F, Nieschlag E. Polymorphism of human pituitary FSH: analysis of immunoreactivity and in vitro bioactivity of different molecular species. J Endocrinol 1994;141(2):359-67
  • Rose MP, Gaines Das RE, Balen AH. Definition and measurement of follicle stimulating hormone. Endocr Rev 2000;21(1):5-22
  • Driebergen R, Baer G. Quantification of follicle stimulating hormone (follitropin alfa): is in vivo bioassay still relevant in the recombinant age? Curr Med Res Opin 2003;19(1):41-6
  • Steelman SL, Pohley FM. Assay of the follicle stimulating hormone based on the augmentation with human chorionic gonadotropin. Endocrinology 1953;53(6):604-16
  • Balasch J, Penarrubia J, Fabregues F, et al. Ovarian responses to recombinant FSH or HMG in normogonadotrophic women following pituitary desensitization by a depot GnRH agonist for assisted reproduction. Reprod Biomed Online 2003;7(1):35-42
  • Balasch J, Vidal E, Penarrubia J, et al. Suppression of LH during ovarian stimulation: analysing threshold values and effects on ovarian response and the outcome of assisted reproduction in down-regulated women stimulated with recombinant FSH. Hum Reprod (Oxford, England) 2001;16(8):1636-43
  • Themmen APN, Huhtaniemi IT. Mutations of gonadotropins and gonadotropin receptors: elucidating the physiology and pathophysiology of pituitary-gonadal function. Endocr Rev 2000;21(5):551-83
  • Simoni M, Gromoll J, Nieschlag E. The follicle-stimulating hormone receptor: biochemistry, molecular biology, physiology, and pathophysiology. Endocr Rev 1997;18(6):739-73
  • Thomas FH, Vanderhyden BC. Oocyte-granulosa cell interactions during mouse follicular development: regulation of kit ligand expression and its role in oocyte growth. Reprod Biol Endocrinol 2006;4:19
  • Knight PG, Glister C. TGF-beta superfamily members and ovarian follicle development. Reproduction (Cambridge, England) 2006;132(2):191-206
  • La Marca A, Sighinolfi G, Argento C, et al. Polymorphisms in gonadotropin and gonadotropin receptor genes as markers of ovarian reserve and response in in vitro fertilization. Fertil Steril 2013;99(4):970-8; e1
  • Simoni M, Casarini L. Potential for pharmacogenetic use of FSH: a 2014-and-beyond view. Eur J Endocrinol 2014;170:R91-107
  • Germond M, Dessole S, Senn A, et al. Successful in-vitro fertilisation and embryo transfer after treatment with recombinant human FSH. Lancet 1992;339(8802):1170
  • Agrawal R, West C, Conway GS, et al. Pregnancy after treatment with three recombinant gonadotropins. Lancet 1997;349(9044):29-30
  • Frydman R, Howles CM, Truong F. A double-blind, randomized study to compare recombinant human follicle stimulating hormone (FSH; Gonal-F) with highly purified urinary FSH (Metrodin) HP) in women undergoing assisted reproductive techniques including intracytoplasmic sperm injection. The French Multicentre Trialists. Hum Reprod (Oxford, England) 2000;15(3):520-5
  • Out HJ, Mannaerts BM, Driessen SG, Bennink HJ. A prospective, randomized, assessor-blind, multicentre study comparing recombinant and urinary follicle stimulating hormone (Puregon versus Metrodin) in in-vitro fertilization. Hum Reprod (Oxford, England) 1995;10(10):2534-40
  • van Wely M, Kwan I, Burt AL, et al. Recombinant versus urinary gonadotrophin for ovarian stimulation in assisted reproductive technology cycles. Cochrane Database Syst Rev 2011(2):CD005354
  • Knezevic I, Griffiths E. Biosimilars--global issues, national solutions. Biologicals 2011;39(5):252-5
  • Wiecek A, Mikhail A. European regulatory guidelines for biosimilars. Nephrol Dial Transpl 2006;21(Suppl 5):v17-20
  • Patel MM, Shah PJ, Patel BM. Insights of biosimilars through SWOT analysis. Expert Opin Biol Ther 2014;14(2):139-44
  • European Medicine Agency. EPAR summary for the public: Ovaleap (follitropin alfa). EMA/562331/2013. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002608/human_med_001689.jsp&mid=WC0b01ac058001d124
  • European Medicine Agency. EPAR summary for the public: Bemfola (follitropin alfa). EMA/CHMP/50313/2014 EMA/688155/2012. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002615/WC500166821
  • Kuhlmann M, Covic A. The protein science of biosimilars. Nephrol Dial Transpl 2006;21(Suppl 5):v4-8
  • Schellekens H. The first biosimilar epoetin: but how similar is it? Clin J Am Soc Nephrol 2008;3(1):174-8
  • Lispi M, Datola A, Bierau H, et al. Heterogeneity of commercial recombinant human growth hormone (r-hGH) preparations containing a thioether variant. J Pharm Sci 2009;98(12):4511-24
  • Ulloa-Aguirre A, Timossi C. Structure-function relationship of follicle-stimulating hormone and its receptor. Hum Reprod Update 1998;4(3):260-83
  • Ebbers HC, Muenzberg M, Schellekens H. The safety of switching between therapeutic proteins. Expert Opin Biol Ther 2012;12(11):1473-85
  • Schellekens H. Bioequivalence and the immunogenicity of biopharmaceuticals. Nat Rev Drug Discov 2002;1(6):457-62
  • Kessler M, Goldsmith D, Schellekens H. Immunogenicity of biopharmaceuticals. Nephrol Dial Transpl 2006;21(Suppl 5):v9-12
  • Barbosa MD, Kumar S, Loughrey H, Singh SK. Biosimilars and biobetters as tools for understanding and mitigating the immunogenicity of biotherapeutics. Drug Discov Today 2012;17(23-24):1282-8
  • Casadevall N, Nataf J, Viron B, et al. Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N Engl J Med 2002;346(7):469-75
  • De Groot AS, McMurry J, Moise L. Prediction of immunogenicity: in silico paradigms, ex vivo and in vivo correlates. Curr Opin Pharmacol 2008;8(5):620-6
  • Basu A, Yang K, Wang M, et al. Structure-function engineering of interferon-beta-1b for improving stability, solubility, potency, immunogenicity, and pharmacokinetic properties by site-selective mono-PEGylation. Bioconjug Chem 2006;17(3):618-30
  • Singh SK. Impact of product-related factors on immunogenicity of biotherapeutics. J Pharm Sci 2011;100(2):354-87
  • Balasch J, Fabregues F, Penarrubia J, et al. Outcome from consecutive assisted reproduction cycles in patients treated with recombinant follitropin alfa filled-by-bioassay and those treated with recombinant follitropin alfa filled-by-mass. Reprod Biomed Online 2004;8(4):408-13
  • Moon SY, Choi YS, Ku SY, et al. Comparison of the efficacy and safety of a new recombinant human follicle-stimulating hormone (DA-3801) with follitropin-alpha (Gonal-F) in women undergoing controlled ovarian hyperstimulation for assisted reproductive technology. J Obstet Gynaecol Res 2007;33(3):305-15

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