Introduction
UDENYCA, a pegfilgrastim biosimilar to Neulasta®, has been a significant player in the biologics market since its launch in 2019. Developed by Coherus BioSciences and soon to be acquired by Intas Pharmaceuticals through its U.S. specialty division, Accord BioPharma, UDENYCA has carved out a niche in the treatment of febrile neutropenia following chemotherapy. Here, we delve into the market dynamics and financial trajectory of this crucial biologic drug.
Market Overview of Biosimilars
The biosimilars market is experiencing rapid growth, driven by the need for cost-effective alternatives to biologic medications. According to the IQVIA Institute for Human Data Science, the U.S. biosimilars market is projected to save the healthcare system up to $60 billion annually by 2023, with a total savings of $153 billion over five years[3].
UDENYCA's Market Position
UDENYCA is one of the key biosimilars in this market, approved in the United States and available in three administration options: prefilled syringe, autoinjector, and on-body injector. This versatility provides patients and healthcare providers with choice, control, and convenience, significantly enhancing patient compliance and care[1].
Patient Uptake and Sales Performance
Since its launch, UDENYCA has treated over 300,000 patients, indicating strong market acceptance. In the 2023 fiscal year, UDENYCA generated $127.1 million in sales. The third quarter of 2024 saw a notable increase, with net product sales reaching $66.1 million, a 30% increase from the second quarter and a 100% increase from the third quarter of 2023[2][5].
Administration Options
The approval of UDENYCA ONBODY™, a novel on-body pegfilgrastim delivery device, has further bolstered its market position. This device, tailored to specific patient needs, has seen a significant demand, contributing to the 54% increase in demand for ONBODY™ in the third quarter of 2024[4].
Financial Performance
Revenue Growth
The financial performance of UDENYCA has been robust. The third quarter of 2024 saw a substantial increase in revenue, driven by higher demand and a higher overall net selling price. For the nine months ended September 30, 2024, net revenue from UDENYCA and other products totaled $212.8 million, compared to $165.7 million in the same period of 2023[2][5].
Cost of Goods Sold (COGS)
The cost of goods sold for UDENYCA has shown a favorable trend. In the third quarter of 2024, COGS was $20.7 million, down from $32.7 million in the same period of 2023. This decrease is largely due to the divestment of products like CIMERLI and YUSIMRY, which previously contributed to higher COGS[2][5].
Operational Expenses
While revenue has increased, operational expenses remain a significant factor. Research and development, selling, general, and administrative expenses have been substantial, though they have shown some reduction. For instance, selling, general, and administrative expenses decreased from $48.2 million in Q3 2023 to $34.7 million in Q3 2024[5].
Acquisition by Accord BioPharma
Strategic Implications
The acquisition of the UDENYCA business by Intas Pharmaceuticals through Accord BioPharma is expected to expand Accord's product portfolio and position the company for accelerated growth in the biosimilars industry. This move aligns with Accord's strategy to deliver more accessible treatment options to patients and strengthen its business footprint in the U.S.[1].
Employee Integration
As part of the acquisition, employees from Coherus BioSciences will join Accord BioPharma, bringing valuable expertise and experience in the development and commercialization of UDENYCA. This integration is expected to enhance the company's capabilities in immune supportive care[1].
Market Impact and Future Prospects
Cost Savings
The introduction and continued success of UDENYCA contribute to the broader cost savings in the healthcare system. Biosimilars like UDENYCA are crucial in reducing healthcare expenditures, making biologic treatments more affordable for patients[3].
Competitive Landscape
The U.S. biosimilars market is becoming increasingly competitive, with several biosimilar products competing with originator medicines. UDENYCA's unique administration options and strong sales performance position it favorably in this competitive landscape[3].
Patient Benefits
The availability of UDENYCA in various administration forms, including the on-body injector, provides significant benefits to patients, especially those living far from their care centers. This flexibility enhances patient care and compliance, making treatment more accessible and convenient[1].
Key Takeaways
- Strong Sales Performance: UDENYCA has shown robust sales growth, with $127.1 million in sales in the 2023 fiscal year and a 100% increase in Q3 2024 compared to Q3 2023.
- Versatile Administration Options: The drug is available in prefilled syringe, autoinjector, and on-body injector forms, enhancing patient compliance and care.
- Acquisition by Accord BioPharma: The acquisition is expected to expand Accord's product portfolio and position the company for growth in the biosimilars industry.
- Cost Savings: UDENYCA contributes to significant cost savings in the healthcare system, aligning with broader industry projections.
- Competitive Market: The drug operates in a competitive biosimilars market but maintains a strong market position due to its unique administration options.
FAQs
What is UDENYCA and how is it used?
UDENYCA is a pegfilgrastim biosimilar to Neulasta®, used to decrease the incidence of infection as caused by febrile neutropenia following chemotherapy. It is administered the day after chemotherapy.
How many patients have been treated with UDENYCA?
Since its launch in 2019, over 300,000 patients have been treated with UDENYCA.
What are the different administration options for UDENYCA?
UDENYCA is available in three administration options: prefilled syringe, autoinjector, and on-body injector.
What is the financial impact of the acquisition by Accord BioPharma?
The acquisition is expected to expand Accord BioPharma's product portfolio and position the company for accelerated growth in the biosimilars industry, with UDENYCA contributing significantly to revenue.
How does UDENYCA contribute to cost savings in healthcare?
UDENYCA, as a biosimilar, helps reduce healthcare expenditures by providing a cost-effective alternative to the originator biologic medication, Neulasta®.
Sources
- Accord BioPharma Announces Agreement by Intas Pharmaceuticals Ltd. to Acquire UDENYCA Business from Coherus BioSciences Inc. - Biospace
- Coherus BioSciences Reports Third Quarter 2024 Financial Results and Provides Business Update - GlobeNewswire
- Biosimilars Market Is Ripe for Cost Savings - Center for Biosimilars
- Coherus Announces FDA Approval of UDENYCA ONBODY™, a Novel and Convenient On-Body Pegfilgrastim Delivery Device - Coherus BioSciences
- Coherus BioSciences Reports Third Quarter 2024 Financial Results - Coherus BioSciences
