Market Dynamics and Financial Trajectory for the Biologic Drug: ZIRABEV
Introduction
ZIRABEV, a biosimilar of the biologic drug Avastin (bevacizumab), has been a significant player in the oncology market since its introduction in the U.S. in December 2019. This article delves into the market dynamics and financial trajectory of ZIRABEV, highlighting its impact on the healthcare system, patient access, and the financial performance of its manufacturer, Pfizer.
Market Entry and Pricing
ZIRABEV was launched at a Wholesale Acquisition Cost (WAC) of $61.34 per 10 mg, representing a 23% discount to the WAC of Avastin[4].
This pricing strategy was aimed at providing a more affordable alternative to the original biologic, thereby increasing access to critical therapies for patients with various types of cancer.
Indications and Usage
ZIRABEV is indicated for the treatment of several types of cancer, including metastatic colorectal cancer, unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, and persistent, recurrent or metastatic cervical cancer. Pfizer also sought to expand the label to include the treatment of epithelial ovarian, fallopian tube, and primary peritoneal cancer[4].
Market Impact and Savings
The introduction of ZIRABEV, along with other oncology biosimilars like RUXIENCE (rituximab-pvvr) and TRAZIMERA (trastuzumab-qyyp), has significantly impacted the oncology market. These biosimilars have driven down the cost of biologic treatments, leading to substantial savings for the healthcare system.
- The U.S. spent $493 billion on medicines in 2019, with $211 billion of that on biologics. Biosimilars like ZIRABEV have contributed to a decline in oncology spending growth from 16% in 2018 to 10% in 2020[3].
- An estimated cumulative maximum potential savings of up to $150 billion over 10 years is projected due to the implementation of all available biosimilars, assuming a 50% market share and prices at 50% of the reference product[1].
Market Share and Adoption
ZIRABEV, along with other Pfizer biosimilars, has quickly gained market share. By late 2019, biosimilars like bevacizumab, rituximab, and trastuzumab had achieved market shares of 74%, 64%, and 60%, respectively, at significant discounts relative to their reference products[3].
Financial Performance of Pfizer
Pfizer's financial performance has been influenced by the launch and adoption of ZIRABEV, although the overall impact is part of a broader portfolio strategy.
- In 2023, Pfizer's revenues declined significantly due to the decrease in sales of COVID-19 products like Comirnaty and Paxlovid. However, excluding these products, Pfizer's revenues grew 7% operationally[2].
- The launch of biosimilars like ZIRABEV contributes to Pfizer's growth goals, particularly in the oncology segment. While the specific revenue figures for ZIRABEV are not isolated in Pfizer's financial reports, the overall growth in the biopharmaceuticals segment is partly attributed to these biosimilars[5].
Cost Savings for Payers and Patients
The introduction of ZIRABEV has led to significant cost savings for both commercial payers and Medicare.
- For a commercial payer, the estimated annual cost savings due to the market shift to bevacizumab-bvzr was $313,363 in Year 1, with cumulative five-year savings of $7,030,924. For Medicare, the estimated annual savings were $92,880 in Year 1, with cumulative five-year savings of $4,059,256[3].
Safety and Efficacy
ZIRABEV has a similar safety and efficacy profile to Avastin, based on clinical trials and regulatory approvals.
- The most common adverse events associated with ZIRABEV include those typical of bevacizumab products, such as hypertension, proteinuria, and thromboembolic events. There are also warnings regarding pregnancy, fertility, and breastfeeding[1].
Regulatory Environment
The regulatory environment has been supportive of biosimilars, facilitating their entry into the market.
- Pfizer's ability to launch ZIRABEV and other biosimilars at discounted prices is a result of the regulatory framework that allows for the approval of biosimilars based on demonstrating biosimilarity to the reference product[4].
Future Outlook
The future outlook for ZIRABEV and other biosimilars is promising, with continued growth in market share and savings expected.
- As more biosimilars enter the market, the competition is likely to increase, driving further price reductions and expanding patient access to critical therapies[3].
Conclusion
ZIRABEV has made a significant impact on the oncology market by offering a cost-effective alternative to Avastin. The financial trajectory of Pfizer, while influenced by various factors including COVID-19 products, reflects the growing importance of biosimilars in their portfolio. The substantial savings generated by ZIRABEV and other biosimilars are crucial for controlling healthcare costs and improving patient access to life-saving treatments.
Key Takeaways
- ZIRABEV is a biosimilar of Avastin, launched in the U.S. in December 2019 at a 23% discount.
- It is indicated for several types of cancer and has contributed to significant cost savings for the healthcare system.
- The market share of ZIRABEV and other oncology biosimilars has grown rapidly, driving down oncology spending growth.
- Pfizer's financial performance has been influenced by the launch of ZIRABEV, although the overall impact is part of a broader portfolio strategy.
- The regulatory environment supports the approval and market entry of biosimilars.
FAQs
Q: What is ZIRABEV and how does it differ from Avastin?
A: ZIRABEV is a biosimilar of Avastin (bevacizumab), offering a similar therapeutic effect at a lower cost. It was launched at a 23% discount to Avastin's Wholesale Acquisition Cost (WAC)[4].
Q: What are the indications for ZIRABEV?
A: ZIRABEV is indicated for the treatment of metastatic colorectal cancer, unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, and persistent, recurrent or metastatic cervical cancer[4].
Q: How has ZIRABEV impacted the oncology market?
A: ZIRABEV has contributed to a decline in oncology spending growth from 16% in 2018 to 10% in 2020 and is expected to generate significant cost savings for the healthcare system over the next decade[3].
Q: What are the estimated cost savings associated with ZIRABEV?
A: For a commercial payer, the estimated annual cost savings due to the market shift to bevacizumab-bvzr was $313,363 in Year 1, with cumulative five-year savings of $7,030,924. For Medicare, the estimated annual savings were $92,880 in Year 1, with cumulative five-year savings of $4,059,256[3].
Q: How does the regulatory environment support the market entry of biosimilars like ZIRABEV?
A: The regulatory framework allows for the approval of biosimilars based on demonstrating biosimilarity to the reference product, facilitating their entry into the market at discounted prices[4].
Sources
- Pfizer Oncology Biosimilar - ZIRABEV Product Monograph[1]
- Pfizer Reports Full-Year 2023 Results - Q4 2023 Earnings Release[2]
- The Promise Of Biosimilars In Cancer Care And Reality Of The U.S. Market - Community Oncology[3]
- Pfizer Brings Three New Biosimilars to U.S. Patients at Substantial Discounts - Pfizer Press Release[4]
- PFIZER REPORTS RECORD FULL-YEAR 2022 RESULTS AND REAFFIRMS FULL-YEAR 2023 GUIDANCE - Q4 2022 Earnings Release[5]
