Amphastar Receives FDA Approval for Generic Teriparatide Injection, Challenging Eli Lilly's FORTEO in $585M Osteoporosis Market
Key Insights
Amphastar Pharmaceuticals received FDA approval for its generic teriparatide injection, marking the company's first pen device combination product and providing a bioequivalent alternative to Eli Lilly's FORTEO.
The approved product targets a substantial $585 million U.S. market for teriparatide injection and is indicated for treating osteoporosis (search) in high-risk patients across multiple populations.
Amphastar plans to launch the product by year-end, leveraging domestic manufacturing capabilities to offer an affordable treatment option for daily osteoporosis (search) therapy.
Amphastar Pharmaceuticals announced that the U.S. Food and Drug Administration has approved the company's Abbreviated New Drug Application for teriparatide injection, USP 560 mcg/2.24mL (250 mcg/mL) single-patient-use prefilled pen. The FDA determined that Amphastar's teriparatide is bioequivalent and therapeutically equivalent to Eli Lilly's FORTEO, positioning the generic manufacturer to compete in a significant osteoporosis (search) treatment market.
First Pen Device Combination Product for Amphastar
"We are proud to announce FDA approval of Amphastar's first-ever pen device combination product, demonstrating our continued commitment to advancing innovative approaches for complex drug delivery mechanisms," said Dr. Jack Zhang, Amphastar's President and Chief Executive Officer. Zhang emphasized that the product provides patients confidence in its reliability and effectiveness while offering a thoughtfully designed, easy-to-use, and affordable option for managing daily osteoporosis (search) therapy.
The company highlighted its domestic manufacturing advantage, with the drug product manufactured entirely in-house at its U.S. facility. "This sets us apart in a market where many competitors rely on overseas production," Zhang noted, emphasizing the company's commitment to domestic innovation, rigorous quality standards, and operational agility.
Broad Therapeutic Indications
The approved teriparatide injection carries three key indications for osteoporosis (search) treatment:
- Treatment of postmenopausal women with osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy
- Increasing bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy
- Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy
Substantial Market Opportunity
According to IQVIA data, the overall U.S. sales for teriparatide injection were approximately $585 million for the 12 months ended September 30, 2025. Amphastar plans to launch its teriparatide injection by the end of the year, positioning itself to capture market share in this substantial therapeutic area.
Expanding Pipeline Portfolio
Beyond the teriparatide approval, Amphastar maintains a robust development pipeline. The company currently has two abbreviated new drug applications and one biosimilar insulin filed with the FDA targeting products with a combined market size of over $1.8 billion. Additionally, three biosimilar products in development target products with a market size exceeding $6 billion, and two generic products in development target products with a market size of over $1 billion, based on IQVIA data for the 12 months ended September 30, 2025.
The company has also entered into an exclusive license agreement with Anji (search) for the development, manufacturing, use, and commercialization of three proprietary peptides. These include an endogenous peptide with a novel mechanism of action that potentially suppresses the growth and metastasis of multiple poorly treated cancers, a peptide-docetaxel conjugate designed to improve selectivity and bioavailability while reducing toxicity, and an anti-VEGFR (search) peptide developed as a topical eye drop for wet age-related macular degeneration (search) treatment.