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EMA approves biosimilar Somatropin from Biopartners Gmbh



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OMNITROPE® (somatropin [rDNA origin] injection)  Structural Formula Illustration


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.




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

OMNITROPE® (somatropin [rDNA origin] injection)  Structural Formula Illustration


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
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

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DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with AFRICURE PHARMA, ROW2TECH, NIPER-G, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Govt. of India as ADVISOR, earlier assignment was with GLENMARK LIFE SCIENCES LTD, as CONSUlTANT, Retired from GLENMARK in Jan2022 Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 32 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 32 PLUS year tenure till date Feb 2023, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 100 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 100 Lakh plus views on dozen plus blogs, 227 countries, 7 continents, He makes himself available to all, contact him on +91 9323115463, email, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 38 lakh plus views on New Drug Approvals Blog in 227 countries...... , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc He has total of 32 International and Indian awards

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