Last updated: February 19, 2026
What is AMJEVITA?
AMJEVITA (adalimumab-adbm) is a biosimilar to AbbVie's Humira (adalimumab). Approved by the FDA in September 2017, it targets inflammatory conditions such as rheumatoid arthritis, plaque psoriasis, and Crohn’s disease. It is marketed by Amgen.
Market Position and Competitive Landscape
Entry and Launch Timing
AMJEVITA entered the U.S. market in late 2017. Its approval came several years after Humira’s market dominance, leveraging the biosimilar pathway to diminish costs.
Key Competitors
| Product |
Manufacturer |
Approval Year |
Indication Coverage |
Market Share (2022) |
Price Reduction (%) |
| Humira (adalimumab) |
AbbVie |
2002 |
Multiple |
70% |
N/A |
| Amjevita (adalimumab/*) |
Amgen |
2017 |
Multiple |
10% (estimate) |
~15-20% |
| Imraldi (adalimumab) |
Biogen/Samsung |
2018 |
Similar |
Smaller share |
20-25% |
| Hulio (adalimumab) |
Mylan/Fresenius |
2019 |
Similar |
Smaller share |
~25% |
Market Drivers
- Patent Expirations: Humira's original patents expired in the U.S. in 2023, opening a broader biosimilar market.
- Cost Savings: Biosimilars like AMJEVITA typically price 15-30% below Humira.
- Physician Adoption: Limited initial interchangeability, but increasing with biosimilar education and regulations.
- Insurance Coverage: Push for biosimilar utilization to reduce healthcare expenditure.
Regulatory and Patent Landscape
Humira faced patent litigations delaying biosimilar entry until 2023. Multiple biosimilars received approval around this period, increasing market competition.
Financial Trajectory and Revenue Impact
Sales Performance
- Initial Sales: Estimated at approximately $900 million in 2018, representing a fraction of Humira’s peak sales.
- Growth Trend: Steady expansion driven by increased adoption, reaching an estimated $2 billion in U.S. sales by 2022.
- Global Sales: Limited data, but Amgen promotes AMJEVITA mainly in North America and select markets.
Market Share Evolution
- Early market share hovered around 2-3%, increasing to roughly 10% post 2020.
- The majority of biosimilar sales faced resistance due to brand loyalty and physician skepticism.
Revenue Projections
- Post-patent expiry, biosimilar market share in the U.S. could reach 30-40% within five years.
- Total TAM (Total Addressable Market): Estimated over $20 billion globally for adalimumab products.
- Bios ขอ E ambitions to capture about 15-20% of this market in the next five years, translating to sales projection of $3-$4 billion globally by 2027.
Pricing and Discount Strategies
- Discounting varies but generally ranges between 15-25% compared to Humira.
- Contractual arrangements with insurers influence actual market penetration.
Challenges and Opportunities
Challenges
- Physician preference for the reference product.
- Limited automatic substitution laws in many jurisdictions.
- Ongoing patent litigations and legal barriers.
Opportunities
- New indications, including hidradenitis suppurativa and juvenile idiopathic arthritis.
- Manufacturer’s focus on biosimilar pipeline expansion.
- Growing acceptance of biosimilars among payers and providers.
Key Market Events
| Event |
Date |
Impact |
| Humira patent expiry in U.S. |
Jan 2023 |
Accelerated biosimilar entry |
| Multiple biosimilar approvals |
2018-2022 |
Increased competition, price pressure |
| FDA biosimilar guidance update |
2020 |
Clarifies biosimilar interchangeability |
Conclusions
AMJEVITA’s market trajectory hinges on US patent landscapes, biosimilar adoption trends, and pricing dynamics. It entered an increasingly competitive space after Humira’s patent expiration. While initial growth was modest, revenues are expected to increase as biosimilar market share expands, particularly post-2023 patent expiration.
Key Takeaways
- AMJEVITA has captured about 10% of the adalimumab biosimilar market in North America as of 2022.
- The biosimilar landscape faces regulatory, legal, and physician adoption challenges but benefits from cost-driven demand.
- U.S. biosimilar sales for adalimumab could reach $3-4 billion by 2027, representing a significant portion of total adalimumab sales.
- Pricing strategies and insurance contracts are critical in driving market share growth.
FAQs
1. How does AMJEVITA compare to Humira in pricing?
It typically sells at a 15-20% discount, depending on negotiations and market conditions.
2. What are the main barriers to biosimilar adoption for AMJEVITA?
Physician preference for the original product, patent litigation, and limited automatic substitution laws.
3. Will AMJEVITA’s market share increase post Humira patent expiry?
Yes, the expiration is expected to significantly boost biosimilar adoption, with market share potentially surpassing 30% within five years.
4. How does regulatory approval affect AMJEVITA’s market?
Regulatory clarity around biosimilar interchangeability influences prescribing practices and market penetration.
5. Are there any new indications for AMJEVITA?
While primarily used for inflammatory diseases, expanded indications depend on regulatory approval and clinical trial outcomes.
References
[1] Food and Drug Administration. (2017). FDA approves Amjevita, the first biosimilar to Humira. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-amjevita-first-biosimilar-humira.
[2] IQVIA. (2022). U.S. Pharmaceuticals and Biologics Market Data.
[3] Amgen. (2022). AMJEVITA (adalimumab-adbm) prescribing information.
[4] U.S. Patent and Trademark Office. (2023). Patent expiration and biosimilar entry data.
