The US Food and Drug Administration (FDA) has approved Ambio’s generic version of Forteo (teriparatide injection) for osteoporosis.
The medicine will be marketed and sold by Ambio’s partner Apotex in the US market.
Teriparatide is a parathyroid hormone analogue administered as a subcutaneous injection in the thigh or abdominal region via a pre-filled pen containing 250 micrograms (mcg) per millilitre of the drug. Each pen can deliver 28 doses of 20mcg medicine.
Ambio founder, board chairman and CEO Chris Bai stated: “The approval further validates our expertise and technological innovation as a developer and manufacturer of complex generic drugs and supports our commitment to bring high quality and affordable therapies to patients.
“We are pleased to partner with Apotex in this effort which allowed them to expeditiously secure FDA approval and immediately execute product launch.”
Ambio focuses on developing new peptide therapies, biosimilar, bioequivalent and other generic drugs with technological advances in synthetic peptide drug development.
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The company develops intricate synthetic peptides that can substitute for branded recombinant peptides.
It is entering collaborations to launch biosimilar treatments for key indications and progressing its new drug pipeline to bolster current therapies and peptide treatments in the diabetes and obesity fields among others.
Apotex global regulatory affairs senior vice-president Kiran Krishnan stated: “The launch of teriparatide injection reflects Apotex’s continued focus on improving access for patients to affordable complex generic drugs.
“We are pleased to deliver this critical product in partnership with Ambio that we believe will be essential in improving the quality of life for osteoporosis patients in the US.”
In January 2022, Ambio introduced the hereditary angioedema treatment, Icatibant, in 14 markets with its partner, Adalvo. The companies have a partnership to develop synthesise and produce the injectable peptide.