SOMATROPIN
The European Medicine agency has approved a biosimilar somatropin from Biopartners GMBH. Somatropin biopartner would be the third biosimilar version of somatropin the European market. Other players selling somatropin inlcude Sandoz and Roche. Sandoz sells under the brand Omnitrope, while Roche which is the innovator of somatropin sells it under the brand name NutropinAq.
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DETAILS OF OMNITROPE
Omnitrope® (somatropin-[rDNA] origin) is a polypeptide hormone of recombinant DNA origin. It has 191 amino acid residues and a molecular weight of 22,125 daltons. The amino acid sequence of the product is identical to that of human growth hormone of pituitary origin (somatropin). Omnitrope® is synthesized in a strain of. Escherichia coli that has been modified by the addition of the gene for human growth hormone. Omnitrope® Cartridge is a clear, colorless, sterile solution for subcutaneous injection. Omnitrope® for Injection is a lyophilized powder that is reconstituted for subcutaneous injection.
Figure 1: Schematic amino acid sequence of human growth hormone including the disulfide bonds
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Each Omnitrope® Cartridge or vial contains the following (see Table 4):
Table 4. Contents of Omnitrope® Cartridges and Vial
Product | Cartridge 5 mg/1.5 mL | Cartridge 10 mg/1.5 mL | For Injection 5.8 mg/vial |
Component | |||
Somatropin | 5 mg | 10 mg | 5.8 mg |
Disodium hydrogen phosphate heptahydrate | 1.3 mg | 1.70 mg | 2.09 mg |
Sodium dihydrogen phosphate dihydrate | 1.6 mg | 1.35 mg | 0.56 mg |
Poloxamer 188 | 3.0 mg | 3.0 mg | – |
Mannitol | 52.5 mg | – | – |
Glycine | – | 27.75 mg | 27.6 mg |
Benzyl alcohol | 13.5 mg | – | – |
Phenol | – | 4.50 mg | – |
Water for Injection | to make 1.5 mL | to make 1.5 mL | – |
Diluent (vials only) | Bacteriostatic Water for Injection | ||
Water for injection | to make 1.14 mL | ||
Benzyl alcohol | 17 mg |