Relative bioavailability of two drug products of somatropin obtained from either the milk of transgenic cows or bacterial culture.

FARIAS JAVIER; FELEDER ETHEL; GONZALEZ ELISEO; HALABE KARINA; CRISCUOLO MARCELO; BERGADÁ IGNACIO; DIEZ ROBERTO

Hormone research in pædiatrics

Basel : Karger

Lugar: Basilea; Año: 2010 vol. 73 p. 258 - 264

1663-2818

Background: Our objective was to assess the relative bioavailability of the first somatropin produced in transgenic cloned cows that carry the human GH gene (Biohormon®) and somatropin produced in E. coli culture (HHT®), the procedure most frequently used for the commercial production of the hormone. Methods: Upon approval by an independent ethics committee and the National Regulatory Agency of Argentina, we compared the time-concentration profiles of somatropin in 24 healthy volunteers, in a randomised, two-period, two-sequence crossover design after inhibition endogenous GH secretion with lanreotide, a long acting somastostatin analogue. After the subcutaneous administration of 1.33 mg of each formulation, serum somatropin was analyzed by chemiluminescent immunoassay and IGF-I by IRMA. Safety was assessed by clinical and laboratory parameters. Pharmacokinetic parameters were calculated with WinNonlin® 5.2 using a non-compartmental model and bioequivalence was assessed. Results: The test/reference ratios of AUC, AUClast and Cmax were 106.4 (CI90% 100.2-112.9); 105.3 (CI90% 99.1-111.8) and 105.49 (CI90% 92.6-120.1), respectively. No serious adverse events were reported and no GH antibodies were detected. Conclusion: This study demonstrates that a single dose of Biohormon®, the first product with somatropin obtained from milk of transgenic mammals, is bioequivalent to the reference product HHT® according to standard criteria.