Introduction to RETACRIT
RETACRIT (epoetin alfa-epbx) is a biosimilar erythropoiesis-stimulating agent (ESA) developed by Pfizer. It was approved by the U.S. Food and Drug Administration (FDA) in May 2018, marking it as the first and only biosimilar epoetin alfa approved in the U.S.[1].
Indications and Usage
RETACRIT is indicated for the treatment of anemia due to various conditions, including chronic kidney disease, certain types of cancer, and the reduction of allogeneic red blood cell transfusions in certain patients. This broad range of indications positions RETACRIT as a significant player in the supportive care segment of the biologics market[1].
Market Approval and Launch
The FDA approval of RETACRIT was based on a comprehensive data package demonstrating a high degree of similarity between RETACRIT and its U.S. reference products, Epogen and Procrit. This approval has expanded the treatment options available to healthcare providers and patients, offering a potentially more affordable alternative to the originator biologics[1].
Market Impact and Adoption
Since its approval, RETACRIT has made significant strides in the market. By Q3 2023, RETACRIT had surpassed the originator products (Epogen and Procrit) in market share, becoming the market leader in the epoetin alfa segment. This shift is attributed to the competitive pricing strategy of biosimilars, which often offer substantial cost savings compared to the reference products[5].
Pricing and Cost Savings
RETACRIT is expected to be available at a significant discount to the current wholesaler acquisition cost (WAC) of Epogen and Procrit. This pricing strategy aligns with the broader trend in the biosimilars market, where biosimilars are generally priced lower than their reference products. For instance, the average sales price (ASP) of biosimilars in the rituximab market has dropped significantly, with biosimilars like Ruxience achieving a market-leading position due to their lower ASP[5].
Financial Trajectory
The approval and successful launch of RETACRIT contribute to Pfizer's overall financial performance, particularly in the context of its biosimilars program. While Pfizer's full-year 2023 revenues saw a significant decline primarily due to the drop in revenues from COVID-19 vaccines and treatments like Comirnaty and Paxlovid, the company's revenues excluding these contributions grew 7% operationally. The growth in the biosimilars segment, including RETACRIT, is expected to be a key driver of future revenue[2].
Revenue Growth and Projections
The biologics market, including biosimilars, is projected to grow significantly. By 2032, the biologics market is expected to reach USD 699.5 billion, with a compound annual growth rate (CAGR) of 7.8% during 2024-2032. This growth is driven by factors such as the rising prevalence of chronic diseases, technological advancements, and the increasing adoption of biosimilars[3].
Cost Savings and Healthcare Impact
The introduction of biosimilars like RETACRIT is expected to bring substantial cost savings to the healthcare system. Projections suggest that the U.S. healthcare system could save up to $60 billion annually by 2023, with a total of $153 billion in savings over a five-year period. These savings can be reallocated to other areas of healthcare, benefiting patients and the broader healthcare community[4].
Competitive Landscape
RETACRIT operates in a competitive biosimilars market, with multiple players vying for market share. As of January 2024, the FDA has approved a total of 45 biosimilars across 14 unique biological molecules, with 38 of these biosimilars having been launched. This competitive environment drives innovation and pricing strategies that benefit patients and healthcare providers[5].
Expert Insights
Industry experts highlight the importance of biosimilars in providing affordable treatment options. For example, George M. Rodgers, M.D., Ph.D., noted that "by providing potentially more affordable therapeutic options, biosimilar medicines can allow for the reallocation of resources to other areas of cancer care. This is positive news for the oncology community"[1].
Key Statistics
- Market Share: By Q3 2023, RETACRIT had surpassed the originator products in market share, becoming the market leader in the epoetin alfa segment[5].
- Cost Savings: The U.S. healthcare system is projected to save up to $60 billion annually by 2023 due to biosimilars like RETACRIT[4].
- Market Growth: The biologics market is expected to reach USD 699.5 billion by 2032, with a CAGR of 7.8% during 2024-2032[3].
Conclusion
RETACRIT has established itself as a significant player in the biologics market, particularly in the supportive care segment. Its approval and market performance highlight the growing importance of biosimilars in providing cost-effective treatment options and driving cost savings in the healthcare system.
Key Takeaways
- First Approved Biosimilar: RETACRIT is the first approved epoetin alfa biosimilar in the U.S.
- Market Leadership: RETACRIT has become the market leader in the epoetin alfa segment by Q3 2023.
- Cost Savings: Biosimilars like RETACRIT are projected to save the U.S. healthcare system up to $60 billion annually.
- Market Growth: The biologics market, including biosimilars, is expected to grow significantly, reaching USD 699.5 billion by 2032.
- Competitive Landscape: RETACRIT operates in a competitive biosimilars market with multiple approved and launched products.
FAQs
Q: What is RETACRIT, and what is it used for?
A: RETACRIT (epoetin alfa-epbx) is a biosimilar erythropoiesis-stimulating agent (ESA) used to treat anemia due to chronic kidney disease, certain types of cancer, and to reduce allogeneic red blood cell transfusions in certain patients.
Q: When was RETACRIT approved by the FDA?
A: RETACRIT was approved by the FDA in May 2018.
Q: How does RETACRIT compare to its reference products in terms of market share?
A: By Q3 2023, RETACRIT had surpassed the originator products (Epogen and Procrit) in market share, becoming the market leader in the epoetin alfa segment.
Q: What are the projected cost savings from biosimilars like RETACRIT?
A: The U.S. healthcare system is projected to save up to $60 billion annually by 2023 due to biosimilars like RETACRIT.
Q: How is the biologics market expected to grow in the coming years?
A: The biologics market is expected to reach USD 699.5 billion by 2032, with a CAGR of 7.8% during 2024-2032.
Sources
- Pfizer's Biosimilar RETACRIT® (epoetin alfa-epbx) Approved by U.S. FDA. Pfizer.
- Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Guidance. Pfizer.
- Biologics Market Size to Reach USD 699.5 Billion by 2032, Impelled by Emergence of Advanced Drug Delivery Systems. Biospace.
- Biosimilars Market Is Ripe for Cost Savings. Center for Biosimilars.
- Biosimilar Market Report - SAMSUNG BIOEPIS. Samsung Bioepis.
Last updated: 2024-12-19
