Ambio Announces US FDA Approval of a Generic Version of Forteo® (Teriparatide Injection) for Its Partner Apotex

Forteo® (teriparatide injection) is indicated for the treatment of osteoporosis

Partner Apotex Corp. (Apotex) to market and sell to the U.S. healthcare market

BEECH ISLAND, S.C.--(BUSINESS WIRE)--Ambio, Inc., an innovative biotech company developing novel peptide drugs, biosimilar, bioequivalent, and other complex generic drugs, announced today that a generic version of Forteo®¹ (teriparatide injection) developed by Ambio and to be marketed and sold by Apotex has been approved by the U.S. Food and Drug Administration (FDA).

“Ambio is a world leader in developing complex peptides. Our highly skilled techniques in controlling various kinds of peptide-related synthetic impurities together with expertise in developing advanced analytical methods to thoroughly characterize the peptides sets us apart in the pharmaceutical industry,” said Simrat Singh, President of Ambio, Inc. “We are thrilled that the teriparatide injection developed by Ambio has received FDA approval.”

“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,” said Chris Bai, Founder, Chairman of the Board, and Chief Executive Officer of Ambio, Inc. “We are pleased to partner with Apotex in this effort which allowed them to expeditiously secure FDA approval and immediately execute product launch.”

"The launch of Teriparatide Injection reflects Apotex's continued focus on improving access for patients to affordable complex generic drugs,” said Kiran Krishnan, SVP of Global Regulatory Affairs at Apotex. "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."

About Teriparatide

Teriparatide Injection is supplied as a single-patient-use pre-filled pen containing 250 mcg/mL, capable of administering 28 daily doses of 20 mcg per pen. Please refer to the complete prescribing information (here) for information on Warnings and Precautions, Adverse Reactions and Contraindications and read the Medication Guide (here).

About Ambio, Inc.

Ambio is an innovative biotech company developing novel peptide drugs, biosimilar, bioequivalent, and other complex generic drugs, with unmatched expertise and technological advances in synthetic peptide drug development. Ambio has expertise in not only developing complex synthetic peptides to replace recombinant brand peptides but most importantly understanding of what the FDA’s expectation is for the regulatory approval process in such cases. We are partnering to launch biosimilar drugs targeting blockbuster indications and advancing our own pipeline of novel drugs to improve upon existing biologics and peptide drugs in the therapeutic areas of diabetes, obesity, and beyond. Our mission is to provide high quality and affordable drugs to patients around the world. For more information, please visit AmbioRX.com and follow us on LinkedIn.

About Apotex Corp.

Apotex Corp. is a US based company, headquartered in Weston, Florida. It and its global affiliates are leaders in generic pharmaceuticals and biosimilars and are committed to supplying patients with a broad portfolio of high-quality, affordable medicines covering all major therapeutic areas.

¹Forteo® is a registered trademark of Eli Lilly Pharmaceuticals.

Susan Sharpe
Linnden Communications
susan@linndencom.com