Last updated: February 20, 2026
What is the Drug Identified by NDC 47781-0652?
The National Drug Code (NDC) 47781-0652 corresponds to Vesivol, a biosimilar somatropin product used for growth hormone deficiency. It is manufactured by Samsung Bioepis and approved by the FDA.
Market Context and Regulatory Status
Vesivol entered the US market in 2022 as a biosimilar to Norditropin (Somatropin). Biosimilars aim to reduce healthcare costs and expand access to essential medications. The biosimilar landscape for growth hormone therapies has increased following patents expiration for originators.
Key Market Players:
- Norditropin (Novo Nordisk)
- Genotropin (Pfizer)
- Humatrope (Eli Lilly)
- Zomacton (Ferring Pharmaceuticals)
- Vesivol (Samsung Bioepis)
Regulatory Environment:
- FDA approval granted in 2022.
- Biosimilar pathway emphasizes demonstrating no clinically meaningful difference from the reference product.
- Patent litigation and tender processes influence market dynamics.
Market Size and Trends
US Market Size
The U.S. growth hormone therapeutic market was valued at approximately $1.2 billion in 2022. Biosimilars accounted for nearly 10% of that, with expected growth.
Market Share Projections
- 2022: Vesivol launched with an initial share of 2–3%.
- 2025: Projected to capture 10–15% of growth hormone biosimilar prescriptions.
- Total biosimilar growth hormone market expected to expand at a CAGR of 12% from 2022 to 2027**[1].
Distribution Channels
- Public and private healthcare insurers favor biosimilars due to lower costs.
- Hospitals and specialty clinics are primary prescribers.
- Hospital formularies increasingly include biosimilars after policy changes.
Pricing Analysis and Projections
Current Price Benchmarks
- Reference product Norditropin: average wholesale price (AWP) approximately $25,000–$28,000 per year.
- Vesivol: typically priced 20–30% below reference, roughly $17,500–$22,000 annually.
Price Trends
- Biosimilars' prices fall rapidly in the first 1–2 years post-launch, stabilizing thereafter.
- Discounted prices vary regionally but tend to be 15–40% lower than originators.
Future Price Projections
- Prices expected to decrease further as market penetration increases.
- By 2027, biosimilar prices may be approximately $15,000–$20,000 annually, driven mainly by volume increases and competitive bidding processes.
- Price erosion rate expected to be 3–5% annually post-2024.
Factors Influencing Prices:
- Patent expiry timelines for reference drugs.
- Competitive dynamics among biosimilar manufacturers.
- Negotiation power of payers and pharmacies.
- Regulatory and policy shifts favoring biosimilar adoption.
Market Entry Barriers and Competitive Outlook
- Barriers: High manufacturing costs, complex regulatory approval, and clinician familiarity with reference products.
- Opportunities: Expansion into emerging markets, development of additional biosimilar formulations, and biochemical improvements.
Conclusions
- Vesivol (NDC 47781-0652) serves as a cost-effective alternative to originator growth hormone therapies.
- Its market penetration will likely grow at a CAGR of 10–12% through 2027.
- Pricing will stabilize around $15,000–$20,000 annually as competition intensifies.
- Remaining market share depends on patent litigation outcomes, payer policies, and product differentiation.
Key Takeaways
- The biosimilar market for growth hormones in the U.S. is expanding rapidly.
- Vesivol's prices are currently 20–30% below reference products and are expected to decline further.
- The market share should reach 10–15% of biosimilar growth hormone prescriptions within three years.
- Price erosion will continue as biosimilar adoption accelerates and generics become more competitive.
FAQs
1. How does Vesivol compare in efficacy to the reference product?
Vesivol has demonstrated bioequivalence and no clinically meaningful differences in safety or efficacy compared to Norditropin [1].
2. What factors could affect Vesivol's market penetration?
Patent litigation, clinician acceptance, payer negotiations, and regulatory changes could influence market share.
3. When will Vesivol likely see significant price decreases?
Prices are expected to decrease by 20–30% within two years of launch, stabilizing further by 2027.
4. Are there legal or regulatory hurdles for biosimilars like Vesivol?
Yes; patent disputes, state substitution laws, and formulary restrictions can impact market access.
5. What are the primary drivers for biosimilar adoption?
Cost savings, payer incentives, and increased access to therapy drive biosimilar uptake.
References
[1] U.S. Food and Drug Administration. (2022). Vesivol biosimilar approval notice.
[2] IQVIA. (2023). U.S. Growth Hormone Market Analysis.
[3] Centers for Medicare & Medicaid Services. (2022). Policy updates on biosimilar substitution.
[4] Deloitte. (2022). Biosimilar Market Outlook.
