Amphastar Receives FDA Approval for Generic Teriparatide Injection, Challenging Eli Lilly's FORTEO in $585M Osteoporosis Market

Amphastar Pharmaceuticals查看公司主页 announced that the U.S. Food and Drug Administration has approved the company's Abbreviated New Drug Application for teriparatide查看药品详情 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查看公司主页's FORTEO查看药品详情, positioning the generic manufacturer to compete in a significant osteoporosis (搜索)搜索该疾病 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 (搜索)搜索该疾病 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查看药品详情 injection carries three key indications for osteoporosis (搜索)搜索该疾病 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查看药品详情 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查看药品详情 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 (搜索)搜索该词条 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查看药品详情 conjugate designed to improve selectivity and bioavailability while reducing toxicity, and an anti-VEGFR (搜索)搜索该靶点 peptide developed as a topical eye drop for wet age-related macular degeneration (搜索)搜索该疾病 treatment.