Amphastar Targets 2027 Launches for Insulin Aspart and GLP-1 Products

Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) highlighted two expected 2027 commercial launches—interchangeable insulin aspart candidate AMP-004 and GLP-1 injectable AMP-018—as central upcoming milestones in its November 2026 corporate presentation. The company also said it expects research and development spending to increase as it shifts its pipeline toward proprietary medicines and biosimilars.

The presentation did not provide quarterly revenue, net income or earnings-per-share figures for the third quarter of 2026. Instead, Amphastar focused on its product portfolio, development timeline and expectations for key marketed products.

Pipeline shifts toward proprietary products and biosimilars

Amphastar projected that proprietary candidates would represent 50% of its 2026 pipeline, while biosimilars would account for 35% and generics for 15%. That compares with a 2021 mix of 21% proprietary products, 16% biosimilars and 63% generics.

The company said it invested $369 million of internally generated funds in R&D over five years and expects spending to rise as it advances proprietary programs. Amphastar has more than 160 R&D employees, over 10 pipeline candidates and more than 25 commercial products, supported by 2.4 million square feet of facilities globally.

AMP-004, an interchangeable insulin aspart biosimilar candidate, and AMP-018, a GLP-1 injectable being developed under an abbreviated new drug application, are both expected to launch commercially in 2027. The presentation cited trailing-12-month IQVIA sales of $1.4 billion for the market associated with AMP-004 and more than $200 million for AMP-018 as of September 30, 2026. These figures describe the underlying markets and are not Amphastar revenue forecasts.

Other planned milestones include filings in the second half of 2027 for AMP-005, a recombinant human insulin biosimilar candidate, and inhalation candidate AMP-017. AMP-028, another biosimilar candidate, remains in development, as do injectable AMP-029 and inhalation product AMP-023.

Amphastar also pointed to recent launches supporting its current product base. Iron sucrose product AMP-002 was launched in the third quarter of 2025, teriparatide candidate AMP-015 followed in December 2025, and ipratropium bromide product AMP-007 launched in April 2026 after receiving approval in February.

BAQSIMI and Primatene MIST remain commercial priorities

For BAQSIMI, Amphastar forecast flat to low-single-digit sales growth in 2026. The intranasal glucagon product generated worldwide annual sales of $185 million in 2025, up from $166 million in 2024, according to the presentation. The company projects peak annual sales of $250 million to $275 million and selling expenses equal to about 15% of BAQSIMI sales.

At peak sales, Amphastar expects BAQSIMI to contribute $2.00 to $2.50 in incremental adjusted earnings per share. The company said a reconciliation of that non-GAAP projection to the closest GAAP measure was unavailable without unreasonable effort.

Amphastar expects mid-single-digit growth in 2026 for Primatene MIST, its proprietary over-the-counter epinephrine inhaler. Annual sales reached $109 million in 2025, compared with $102 million in 2024. Growth initiatives include an advertising campaign, expanded physician sampling and development of a next-generation version using a patented propellant with low global-warming potential.

Proprietary peptide programs remain largely early-stage

The company’s proprietary pipeline spans oncology, ophthalmology and inflammatory conditions. AMP-105 is a potential first-in-class peptide being studied for several cancers, while AMP-107 is being developed as a non-invasive eye-drop alternative to injected anti-VEGF therapies for wet age-related macular degeneration and diabetic macular edema.

AMP-109, a peptide-coupled docetaxel candidate, is intended for solid tumors including pancreatic, gastrointestinal and non-small cell lung cancers. Amphastar reported preclinical results in which the high-dose group achieved a 99.56% tumor-inhibition rate in a pancreatic cancer mouse model, with complete tumor regression or disappearance in nine of 10 mice after a 21-day treatment period and 21-day observation period. These findings are preclinical and do not establish outcomes in humans.

AMP-110 is a synthetic human corticotropin analog under development for conditions including acute multiple sclerosis and rheumatoid arthritis exacerbations, gout flares and ocular inflammation. In a rat model of endotoxin-induced uveitis, the candidate reduced inflammation, with recovery scores described as comparable to porcine ACTH within 24 to 48 hours after dosing.

The development schedule assumes standard enrollment timelines and potential expedited regulatory pathways. Amphastar cautioned that clinical-trial results, regulatory filings and approvals, launch timing, market potential and future financial performance are subject to uncertainty. Actual outcomes could differ materially from management’s expectations because of development, regulatory, commercial, competitive and operational risks.