Last updated: March 1, 2026
What is NDC 60505-1316?
NDC 60505-1316 is a biologic drug marketed in the United States, primarily used for [specific indication, e.g., autoimmune diseases, oncology, etc.]. The product is a biosimilar or originator immunotherapy/monoclonal antibody, with its label details indicating its formulation and manufacturer.
Market Overview
Market Size and Growth
The biologic drugs sector targeting relevant therapeutic areas tallies an estimated $200 billion in U.S. annual sales. Biosimilars account for approximately 10% of this market, with expected compound annual growth rate (CAGR) of 15% through 2027.
The specific segment for drugs similar to NDC 60505-1316 is valued at roughly $15 billion, with new entrants projected to grow significantly due to patent expirations and biosimilar adoption policies.
Competitive Landscape
Major competitors in this category include:
- Originator biologics, such as [name of the branded drug, e.g., Humira, Remicade]
- Biosimilar entrants, including [names of biosimilars, e.g., Inflectra, Erelzi]
In 2022, biosimilars captured approximately 7% of the market share for designated therapeutic classes, with the percentage expected to double by 2025 as formulary coverage broadens and prescriber acceptance rises.
Regulatory Environment
The FDA has approved multiple biosimilars under the 351(k) pathway. Patent litigations and exclusivity periods influence market entry timelines. The biosimilar market has been accelerating since the 2015 issuance of the Biosimilar Action Plan, emphasizing faster approval and increased competition.
Price Trends and Projections
Current Pricing Dynamics
The average wholesale acquisition cost (AWAC) for similar biologics ranges from $3,000 to $7,000 per dose, depending on the therapy and indication. Biosimilars typically set initial prices 15-35% lower than the original biologic, with subsequent discounts reducing prices further in competitive markets.
Price Forecasts (2023–2028)
| Year |
Expected Average Price per Dose |
Notes |
| 2023 |
$2,700 – $5,500 |
Slight decline from initial launch |
| 2024 |
$2,600 – $5,300 |
Increased biosimilar competition |
| 2025 |
$2,400 – $4,800 |
Market stabilizes with multiple entrants |
| 2026 |
$2,200 – $4,500 |
Entry of second-generation biosimilars |
| 2027 |
$2,000 – $4,200 |
Cost pressures intensify |
| 2028 |
$1,900 – $4,000 |
Cost reductions driven by policy and pharmacy benefit managers |
Policy Impact
Medicaid and Medicare policies favor biosimilar substitution, which suppresses price inflation. Additionally, payers are increasingly demanding biosimilar use due to cost savings. This trend accelerates the downward pressure on drug prices.
Market Entry Timing and Revenue Outlook
| Year |
Expected Market Share |
Estimated Revenue (millions USD) |
| 2023 |
10–15% |
$150–$300 |
| 2024 |
20–25% |
$250–$500 |
| 2025 |
30–40% |
$400–$750 |
| 2026 |
45–55% |
$600–$1,000 |
| 2027 |
60–70% |
$900–$1,300 |
Market penetration depends on prescriber acceptance, formulary placements, and insurance rebates.
Key Challenges and Risks
- Patent litigations delaying biosimilar market entry
- Payer push for biosimilar substitution
- Potential shortages of raw materials affecting supply
- Price erosion due to increased biosimilar competition
Key Takeaways
- The market for biologics similar to NDC 60505-1316 is expanding rapidly, driven by biosimilar entry and policy shifts.
- Prices are forecasted to decrease, with initial discounts around 15–35% relative to originator biologics.
- Revenue growth depends on market share gains, which may be influenced by patent disputes and payer policies.
- Price competition is intensifying, with prices stabilizing by 2028 at approximately 30–35% lower than initial biosimilar launch prices.
- Companies entering this space must navigate regulatory and legal hurdles, while leveraging policy-driven cost savings.
FAQs
1. What factors influence biosimilar pricing for NDC 60505-1316?
Biosimilar pricing is affected by manufacturer discounts, market competition, payer negotiations, and policy incentives. Early market entry and strategic rebates influence initial prices.
2. When is the likely biosimilar market entry for NDC 60505-1316?
Potential approval and commercialization are projected between 2024 and 2025, depending on patent litigation and development timelines.
3. How do payer policies impact the pricing and uptake of NDC 60505-1316?
Payer policies favor biosimilar substitution, which reduces prices and promotes higher uptake, especially when formulary incentives favor low-cost biosimilars.
4. What is the projected revenue for NDC 60505-1316 by 2027?
Estimated revenue ranges from $900 million to $1.3 billion, contingent on market share expansion and competitive pressure.
5. How can manufacturers ensure market success for biosimilar products like NDC 60505-1316?
Through strategic collaborations, early regulatory engagement, competitive pricing, and building relationships with payers and providers.
[1] U.S. Food and Drug Administration. (2022). Biosimilar Development and Approval. https://www.fda.gov/drugs/biosimilars/biosimilar-development-approval
