Somatropin biosimilar(Bio-Ker s.r.l.)

A multicentre trial with recombinant somatropin was initiated in West Germany in early 1986. Acceptance of patients to the study was determined according to criteria outlined in a detailed study protocol. A total of 62 patients with GH deficiency has now been treated with recombinant somatropin for a minimum of 12 months. Of these, 34 were previously untreated and 28 had previously received pituitary GH. Recombinant somatropin, 12 IU/m2/week, was administered subcutaneously, divided into six doses. Height velocities increased from 3.4 cm/year (pretreatment) to 10.4 cm/year in the previously untreated group, and from 6.0 cm/year during the last year on pituitary GH to 8.3 cm/year for the previously treated patients. Tolerance of recombinant somatropin was good, and no anti-GH antibodies were detected in any of the patients.

Bierich, J. R. (Department of Paediatrics, University of Tübingen, Tübingen, West Germany). Multicentre clinical trial of authentic recombinant somatropin in growth hormone deficiency. Acta Paediatr Scand [Suppl] 337:135, 1987.A German multicentre trial of recombinant somatropin was cdmmenced in March 1986. A total of 77 patients with hGH deficiency were recruited, with heights at least 2.5 SD below the normal mean. Of these, 49 were previously untreated (naïve) and 28 had previously received pituitary hGH. Recombinant somatropin, 12 IU/m2/week was administered subcutaneously, divided into six doses. In the naive group, the height velocity reached 14.9 cm/year in the first 3 months, and thereafter stabilized at 12 cm/year. In the previously treated patients, the growth rate was 10.7 cm/year in the first 3 months, and 8.5 cm/year at 9 and 12 months. There were no abnormal findings in tests of laboratory parameters. No anti‐hGH antibodies were detected in any of the patients; seven patients had anti‐ECP antibodies, but in six of these the antibodies were already present before treatment.