Drug intelligence / Profile preview

AMP-028

Development stage: Preclinical
Lead developer: Amphastar Pharmaceuticals
Administration: Injectable

Overview

AMP-028 is a biosimilar candidate being developed by Amphastar Pharmaceuticals. It is an injectable product currently in the preclinical stage of development. While the specific reference biologic and therapeutic indications have not been publicly disclosed, the product is designed to target a high-value market with over $2 billion in annual sales (IQVIA) that currently lacks interchangeable biosimilars. The active pharmaceutical ingredient (API) for AMP-028 is manufactured at Amphastar's facility in Éragny-sur-Epte, France, leveraging the company's vertically integrated manufacturing capabilities. This project represents a strategic shift for Amphastar toward high-value, advanced therapeutic areas outside of its traditional insulin portfolio.

Beyond the preview

Go deeper on AMP-028.

Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.

Clinical trials

Follow clinical development from study design and recruitment through results.

Trial phase
Status
Readouts

Indications & development

Explore development by indication, patient population, and geography.

Indications
Development status
Countries

Licensing & deals

Trace asset ownership, licensing agreements, and commercial partnerships.

Partners
Deal terms
Milestones

Patents & exclusivity

Explore the patent landscape and regulatory exclusivity around an asset.

Patents
Expiration dates
Exclusivity

Competitive landscape

Compare development programs by target, modality, and indication.

Competing assets
Targets
Development stage

Research & analysis

Connect source evidence and development news to your research questions.

Publications
News
Analysis

Bring the full picture into focus.

See how Gosset can support your research on AMP-028.

Explore the full profile