About somatropin recombinant
Somatropin recombinant manufacturers include Novo Nordisk (Norditropin), Pfizer (Genotropin), Eli Lilly (Humatrope), Merck KGaA (Saizen), Ferring (Zomacton), Sandoz (Omnitrope, the first biosimilar) and GeneScience in China. Somatropin is recombinant human growth hormone, identical to the hormone made by the pituitary gland. It is used to treat growth failure in children and growth hormone deficiency in adults. Pharmaceutical companies can source somatropin injections, biosimilar dossiers and drug substance through out-licensing, supply or technology transfer.
Somatropin recombinant key facts
|
Property |
Somatropin recombinant |
|---|---|
|
INN |
Somatropin |
|
Molecule type |
Recombinant human growth hormone, 191 amino acids, about 22 kDa |
|
ATC code |
H01AC01 |
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Drug class |
Growth hormone (somatotropin) |
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Main brands |
Norditropin (Novo Nordisk); Genotropin (Pfizer); Humatrope (Eli Lilly); Nutropin (Genentech / Roche); Saizen (Merck KGaA); Zomacton (Ferring); Omnitrope (Sandoz) |
|
Long-acting form |
Lonapegsomatropin (Skytrofa, Ascendis Pharma), a once-weekly prodrug of somatropin |
|
Dosage forms |
Powder and solution for subcutaneous injection; cartridges, prefilled pens and needle-free devices |
|
Paediatric indications |
Growth hormone deficiency; Turner syndrome; Prader-Willi syndrome; children born small for gestational age; chronic kidney disease; SHOX deficiency; Noonan syndrome; idiopathic short stature (US) |
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Adult indication |
Adult growth hormone deficiency |
|
First recombinant approval |
US FDA, 1985 |
|
First biosimilar |
Omnitrope (Sandoz), EU, April 2006 |
|
Generic / biosimilar status |
Several biosimilars approved in the EU and other markets |
Somatropin recombinant manufacturers and licensing history
Recombinant growth hormone replaced growth hormone extracted from human pituitary glands in 1985, after cases of prion disease linked to the extracted product. Genentech's somatrem was first, followed by somatropin products from Eli Lilly, Pfizer, Novo Nordisk, Merck KGaA and Ferring.
In April 2006, Sandoz's Omnitrope became the first biosimilar approved in the EU under the new biosimilar pathway. In China, GeneScience Pharmaceuticals is a major producer, including a long-acting PEGylated form. Ascendis Pharma's lonapegsomatropin (Skytrofa) is a once-weekly prodrug that releases somatropin.
Somatropin is produced in E. coli or mammalian cells. Buyers should confirm the expression system, purity and isoform profile, device compatibility, GMP status and biosimilar comparability data before choosing a partner.
Somatropin recombinant dosage forms and dossier types
Somatropin is supplied as powder or solution for subcutaneous injection, usually in cartridges for pen devices.
|
Form |
Strengths |
Typical dossier |
Notes |
|---|---|---|---|
|
Somatropin solution in cartridges / pens |
E.g. 5, 10, 15 mg (product-specific) |
EU biosimilar (Art. 10(4)); US BLA / 505(b)(2) historical |
Main form for licensing |
|
Somatropin powder for injection |
Per product |
EU biosimilar; national |
Reconstitution needed |
|
Somatropin drug substance |
Bulk |
Biologics master file |
E. coli or mammalian cells |
|
Target market |
Dossier format |
Key requirement |
|---|---|---|
|
European Union |
Biosimilar MAA |
Comparability to reference; device data |
|
United States |
BLA (biosimilar 351(k)) |
Interchangeability considerations |
|
China, Asia, Latin America |
National biologic dossier |
Local clinical data often required |
Somatropin recombinant regulatory and patent status
Recombinant somatropin was first approved in the US in 1985. Basic patents expired long ago, and several biosimilars have been approved since Omnitrope in the EU in April 2006. Device and formulation patents may still apply to specific products. In the US, somatropin products moved to the biologics framework in 2020.
Somatropin recombinant mechanism of action and therapeutic use
Somatropin binds growth hormone receptors and stimulates the liver and other tissues to produce insulin-like growth factor 1 (IGF-1). This drives bone growth in children and helps regulate body composition and metabolism in adults. Somatropin is injected daily, or weekly for long-acting forms, to treat growth failure in children and growth hormone deficiency in adults.
Somatropin recombinant licensing and sourcing
Somatropin suppliers and licensing partners typically offer biosimilar dossier out-licensing, finished-product supply or technology transfer. Buyers usually compare GMP status, comparability data, device format and territory availability. Current offers and supplier contacts are listed among the somatropin recombinant manufacturers on Pipelinepharma.
Frequently asked questions about somatropin recombinant
Who are the main somatropin manufacturers? Novo Nordisk, Pfizer, Eli Lilly, Merck KGaA, Ferring and Sandoz are major producers. GeneScience is a leading producer in China.
Is there a biosimilar somatropin? Yes. Sandoz's Omnitrope became the first EU biosimilar in April 2006, and several others have since been approved.
What is somatropin used for? Somatropin treats growth failure in children, including growth hormone deficiency and Turner syndrome, and growth hormone deficiency in adults.
What forms of somatropin are available? Somatropin is available as powder or solution for subcutaneous injection, mostly in cartridges or prefilled pens.
What is long-acting growth hormone? Long-acting forms, such as lonapegsomatropin, are injected once weekly instead of daily. Other weekly products, such as somapacitan and somatrogon, are modified growth hormone molecules.
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