- Trial Phase
- Approved
- Time to Market
- Already approved and commercially available in the US since January 2023 and in Europe since 2018.
- Why 3/10
- AMJEVITA is already approved and marketed with no pending PDUFA, pivotal readout, or Advisory Committee date in the next 12 months; it is a mature commercial product within Amgen's diversified portfolio, so there is no hard binary catalyst to drive a concentrated share-price move.
AMJEVITA is a mature, approved biosimilar with no upcoming binary regulatory catalysts. The key metric to watch is quarterly global sales growth (Q3 2026: $191M, +24% YoY) and whether US sales can recover from the Q2 2026 trough of $19M. With 10 adalimumab biosimilars now approved, pricing pressure and market share dynamics will determine whether this product can sustain mid-single-digit revenue contribution for Amgen.
Price Chart
Executive Summary
AMJEVITA (adalimumab-atto) is Amgen's FDA-approved biosimilar to AbbVie's Humira (adalimumab), an anti-TNF-alpha monoclonal antibody used to treat inflammatory conditions. It was the first Humira biosimilar approved in the US (September 2016) and launched in January 2023. The drug now faces a crowded field of 10 approved adalimumab biosimilars. Global sales reached $191 million in Q3 2026 (up 24% year-over-year), but US sales collapsed to just $19 million in Q2 2026 amid intense competition and payer dynamics. AMJEVITA is a small component of Amgen's diversified portfolio, representing roughly 2% of the company's ~$39 billion annual revenue run rate. It has FDA interchangeable status but no pending regulatory catalysts, making it a steady commercial product rather than a binary event driver for Amgen stock.
How It Works
AMJEVITA is a biosimilar (a near-identical copy) of Humira (adalimumab), one of the world's best-selling prescription drugs. It is an anti-TNF-alpha monoclonal antibody that works by blocking a protein called TNF-alpha, which drives inflammation in conditions like rheumatoid arthritis, psoriasis, Crohn's disease, and ulcerative colitis. By neutralizing TNF-alpha, the drug reduces inflammation and slows disease progression. As a biosimilar, AMJEVITA has the same amino acid sequence and mechanism of action as Humira but is typically sold at a discount.
Trial Status
AMJEVITA was approved by the FDA on September 23, 2016, as a biosimilar to Humira under BLA 761024. It received interchangeable designation via a supplemental BLA approved in 2024/2025. The product launched commercially in the US in January 2023 and has been marketed in Europe as AMGEVITA since 2018. No active clinical trials are ongoing for this approved biosimilar.
The Two-Sided Case
Upcoming Catalysts
- No upcoming regulatory catalysts (PDUFA, AdComm, or pivotal readout) are scheduled for this already-approved, marketed drug.
- Quarterly earnings reports will disclose ongoing global sales trends; Q3 2026 showed $191M (+24% YoY).
- Continued market share shifts among the 10 approved adalimumab biosimilars will determine long-term revenue trajectory.
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Amgen PRESS-RELEASE AMGN ·Originating report