ZARXIO Drug Profile

Summary for Tradename: ZARXIO

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for ZARXIO
Recent Clinical Trials:	See clinical trials for ZARXIO

See drug prices for ZARXIO

Recent Clinical Trials for ZARXIO

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Stanford University	Phase 1/Phase 2
National Cancer Institute (NCI)	Early Phase 1
Rutgers, The State University of New Jersey	Early Phase 1

See all ZARXIO clinical trials

Pharmacology for ZARXIO

Physiological Effect	Increased Myeloid Cell Production
Established Pharmacologic Class	Leukocyte Growth Factor
Chemical Structure	Granulocyte Colony-Stimulating Factor

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for ZARXIO Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ZARXIO Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for ZARXIO Derived from Patent Text Search

No patents found based on company disclosures

ZARXIO Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory of Zarxio

Introduction to Zarxio

Zarxio, a biosimilar version of Neupogen (filgrastim), was launched in the US in September 2015. It is the first short-acting filgrastim biosimilar to be approved by the FDA, marking a significant milestone in the biosimilar revolution in the US[1][3].

Market Share and Adoption

The initial uptake of biosimilars in the US market has been slower than anticipated, but Zarxio's adoption has been steady and gradually eroding Neupogen's market share. By the end of 2016, Zarxio had captured 15% of the SA G-CSF market, with sales reaching approximately $129 million[1]. This growth can be attributed to increased promotional activity, physician education, and improved familiarity among payers and physicians with biosimilars[1].

Pricing and Discounting

Pricing has been a crucial factor in Zarxio's success. Initially launched with a lower discount of 15%, Zarxio has increased its rebates over time. By Q1 2017, Zarxio offered a 15% rebate, which helped secure favored tier coverage and formulary exclusivity from payers like CVS Health Corporation and UnitedHealth Group[1]. This strategy has allowed Zarxio to gain traction in the market despite initial slow adoption.

Physician Education and Detailing

Physician education has played a pivotal role in Zarxio's adoption. Sandoz, the manufacturer of Zarxio, significantly increased promotional spend on detailing and physician education. In Q1 2016, Sandoz detailed Zarxio approximately four times more than Neupogen, which contributed to the uptick in sales[1]. The emphasis on physician buy-in underscores the importance of educational efforts in biosimilar adoption.

Financial Performance

Sandoz, the company behind Zarxio, has reported steady financial growth. In 2023, Sandoz achieved a 7% growth in net sales to third parties in constant currencies, with core EBITDA reaching $1.7 billion[5]. This financial performance is indicative of the company's strategic efforts to sustain growth in the biosimilar market.

Global Market Trends

The global filgrastim biosimilars market is expected to grow significantly. From $0.75 billion in 2021 to $0.88 billion in 2022, the market is projected to reach $1.19 billion by 2026 at a CAGR of 8.0%[4]. This growth is driven by strategic collaborations and the increasing acceptance of biosimilars globally.

Challenges and Future Outlook

Despite the positive trends, the biosimilar market faces challenges such as legal battles over manufacturing processes and regulatory hurdles. However, companies like Sandoz are adapting by developing innovative products and forming strategic alliances to sustain growth in the competitive market[4].

Key Takeaways

1. Slow but Steady Adoption: Zarxio's adoption has been slower than anticipated but has shown steady growth over time.
2. Pricing Strategy: Increased rebates and discounts have secured favored tier coverage and formulary exclusivity.
3. Physician Education: Significant emphasis on physician education and detailing has contributed to increased sales.
4. Financial Performance: Sandoz has reported steady financial growth, indicating the company's strategic efforts in the biosimilar market.
5. Global Market Trends: The global filgrastim biosimilars market is expected to grow significantly, driven by strategic collaborations and increasing acceptance.

FAQs

1. What was the initial discount offered by Zarxio?

   • The initial discount offered by Zarxio was 15%[1].

2. How has Zarxio's market share evolved since its launch?

   • Zarxio's market share grew from 2% at the end of December 2015 to 15% by the end of 2016[1].

3. What role has physician education played in Zarxio's success?

   • Physician education and detailing have significantly contributed to Zarxio's increased sales and adoption[1].

4. How has Sandoz performed financially in recent years?

   • Sandoz reported a 7% growth in net sales to third parties in constant currencies in 2023, with core EBITDA reaching $1.7 billion[5].

5. What are the projected growth rates for the global filgrastim biosimilars market?

   • The global filgrastim biosimilars market is projected to grow from $0.75 billion in 2021 to $1.19 billion by 2026 at a CAGR of 8.0%[4].

Sources

1. [1] https://gabi-journal.net/major-lessons-learned-from-zarxios-us-launch-the-start-of-a-biosimilar-revolution.html
2. [3] https://www.analysisgroup.com/biosimilar-revolution-is-just-beginning-in-the-us-forum/
3. [4] https://www.globenewswire.com/news-release/2023/05/02/2658894/28124/en/Global-Filgrastim-Biosimilars-Market-Research-Report-2023-Focus-on-Zarxio-Nivestym-and-Releuko.html
4. [5] https://www.annualreport.sandoz.com

Last updated: 2024-12-18