Introduction
AMJEVITA, Amgen's biosimilar to AbbVie's blockbuster drug Humira, has been a highly anticipated entry into the U.S. biologics market. Since its launch in January 2023, the drug has faced several challenges and opportunities that have shaped its market dynamics and financial trajectory.
Launch and Initial Market Impact
AMJEVITA was the first adalimumab biosimilar to enter the U.S. market, following its FDA approval in 2016. However, its launch was delayed due to AbbVie's aggressive patent protection strategies[3].
Upon launch, AMJEVITA had a brief period of exclusivity, competing directly with Humira for six months. During this time, Amgen adopted a dual-pricing strategy, offering AMJEVITA at two price points: one at 55% below Humira's list price and another at 5% below[1].
Sales Performance in the U.S.
The initial sales figures for AMJEVITA were promising, with $51 million in revenue in the first quarter of 2023. However, this momentum was short-lived. In the second quarter, U.S. sales dropped to $19 million, a 63% decline from the previous quarter. This drop was attributed to inventory drawdown after the initial launch stockpiling and changing payer behavior[1][4].
Global Sales Performance
In contrast to the U.S. market, AMJEVITA (marketed as Amgevita outside the U.S.) has shown significant growth globally. In the second quarter of 2023, global sales increased by 29% year-over-year, with $131 million in sales outside the U.S.[1][4].
Payer Dynamics and Rebate Impact
One of the critical factors affecting AMJEVITA's uptake in the U.S. is the complex rebate dynamics managed by pharmacy benefit managers (PBMs). Despite the significant discount offered by AMJEVITA, PBMs have favored the more expensive version due to rebate structures, which has hindered the biosimilar's adoption[1].
Competitive Landscape
The biologics market, particularly for adalimumab, is becoming increasingly competitive. Multiple biosimilars are expected to launch in the coming months, which will further shape the market dynamics. Amgen anticipates that the product mix and payer negotiations will continue to evolve, potentially driving greater utilization of biosimilars in 2024[1].
Financial Impact on Amgen
The performance of AMJEVITA has had a mixed impact on Amgen's financials. While the drug's U.S. sales have been disappointing, global sales have been robust. Amgen's overall revenue for the second quarter of 2023 was $7 billion, a 6% increase year-over-year, driven by strong performances from other products like Repatha and Prolia[1].
Guidance and Projections
For the full year 2024, Amgen has adjusted its revenue projections to a range of $32.8 billion to $33.8 billion, reflecting both the challenges faced by AMJEVITA and the overall performance of its product portfolio. The company also expects GAAP EPS in the range of $6.57 to $7.62 and non-GAAP EPS in the range of $19.10 to $20.10[2].
Impact of Horizon Acquisition
Amgen's financial trajectory is also influenced by its acquisition of Horizon Therapeutics, expected to be completed by the end of 2024. This acquisition is not included in the current revenue projections but is anticipated to add significant value to Amgen's portfolio in the future[1][2].
Market Savings and Clinical Impact
The introduction of biosimilars like AMJEVITA is expected to drive significant cost savings in the healthcare sector. According to IQVIA, biosimilars could save the U.S. healthcare system up to $180 billion by 2027, despite an overall spending increase. This has already led to an additional 150 million days of therapy, enhancing patient access to biologic treatments[3].
Industry Expert Insights
Industry experts and company executives have provided insights into the challenges and opportunities facing AMJEVITA. Murdo Gordon, Amgen's chief of global commercial operations, highlighted the new payer behavior and inventory dynamics affecting sales. Richard Gonzalez, AbbVie's CEO, noted that Humira is competing effectively against biosimilar offerings, but acknowledged the impact of biosimilar competition on Humira's sales[1][4].
Future Outlook
As the biosimilar market continues to evolve, AMJEVITA's performance is expected to stabilize and potentially improve. Amgen is awaiting the next payer negotiation cycle in 2024, which could drive greater utilization of biosimilars. The global market, particularly outside the U.S., remains a strong growth area for AMJEVITA[1].
Key Takeaways
- Launch and Initial Sales: AMJEVITA launched in January 2023 with initial U.S. sales of $51 million, but saw a 63% decline in the second quarter.
- Global Performance: Global sales of AMJEVITA have been strong, with a 29% year-over-year increase.
- Payer Dynamics: Complex rebate structures have hindered AMJEVITA's adoption in the U.S.
- Financial Impact: Mixed financial impact with strong overall revenue but disappointing U.S. sales for AMJEVITA.
- Guidance and Projections: Adjusted revenue projections for 2024 reflect both challenges and strong performances from other products.
- Market Savings: Biosimilars are expected to drive significant cost savings and enhance patient access.
FAQs
What is AMJEVITA, and when was it launched in the U.S.?
AMJEVITA is Amgen's biosimilar to AbbVie's Humira, launched in the U.S. on January 31, 2023.
Why did AMJEVITA's U.S. sales decline significantly in the second quarter of 2023?
The decline was attributed to inventory drawdown after the initial launch stockpiling and changing payer behavior due to complex rebate dynamics.
How has AMJEVITA performed globally?
Globally, AMJEVITA (marketed as Amgevita outside the U.S.) has shown strong growth, with a 29% year-over-year increase in sales.
What is the expected impact of biosimilars on the healthcare sector?
Biosimilars are expected to save the U.S. healthcare system up to $180 billion by 2027 and have already led to an additional 150 million days of therapy.
How does the acquisition of Horizon Therapeutics impact Amgen's financial projections?
The acquisition is expected to add significant value but is not included in the current revenue projections for 2024.
References
- FiercePharma: Amgen's hyped Humira biosimilar generates just $19M in Q2 sales[1].
- InvestingNews: AMGEN REPORTS SECOND QUARTER 2024 FINANCIAL RESULTS[2].
- Drug Topics: A Biosimilar Wave Looms Large Over US Biologics Market[3].
- AJMC: Amgen Announces $19M in Q2 Revenue From Amjevita; Humira Down 26% in US[4].
- PR Newswire: AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS[5].
Last updated: 2024-12-19
