Drug Price Trends for NDC 50419-0540

Average Pharmacy Cost for 50419-0540

Drug Name	NDC	Price/Unit ($)	Unit	Date
KERENDIA 10 MG TABLET	50419-0540-06	22.87377	EACH	2026-01-21
KERENDIA 10 MG TABLET	50419-0540-01	22.87377	EACH	2026-01-01
KERENDIA 10 MG TABLET	50419-0540-02	22.87377	EACH	2026-01-01
KERENDIA 10 MG TABLET	50419-0540-02	21.95306	EACH	2025-12-17

Best Wholesale Price for NDC 50419-0540

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

Ranibizumab Biosimilar (NDC 50419-0540) Market Analysis and Price Projections

Last updated: February 17, 2026

This analysis details the market landscape and price projections for ranibizumab biosimilar, identified by NDC 50419-0540. The global biosimilar market, particularly for ophthalmology indications, is experiencing significant growth driven by patent expiries of reference biologics and increasing demand for cost-effective treatment alternatives. Ranibizumab, a vascular endothelial growth factor A (VEGF-A) inhibitor, is primarily used to treat wet age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). The introduction of biosimilars is expected to reduce treatment costs and broaden patient access.

What is the Market Size for Ranibizumab Biosimilars?

The global market for ranibizumab biosimilars is projected to reach approximately $7 billion by 2030, with a compound annual growth rate (CAGR) of 15.2% from 2023 to 2030 [1]. This growth is underpinned by the increasing prevalence of ocular diseases requiring VEGF-A inhibition therapies and the strategic market entry of multiple biosimilar manufacturers. The reference product, Lucentis (ranibizumab), generated substantial revenue prior to biosimilar competition, establishing a well-defined patient population and treatment pathway.

Key Market Drivers:

• Growing Prevalence of Ocular Diseases: The incidence of wet AMD, DME, and RVO is on the rise globally, primarily due to an aging population and increasing rates of diabetes [2].
• Patent Expiries of Reference Biologics: The expiry of key patents for Lucentis opened the door for biosimilar development and market entry.
• Cost Savings: Biosimilars offer a lower price point compared to the originator biologic, enabling healthcare systems and patients to achieve significant cost savings, thereby increasing treatment accessibility [3].
• Favorable Regulatory Pathways: Regulatory agencies worldwide have established streamlined pathways for biosimilar approval, accelerating market entry.
• Increasing Healthcare Expenditure: Global healthcare spending continues to rise, supporting the adoption of new and cost-effective treatments.

Who are the Key Players in the Ranibizumab Biosimilar Market?

Several pharmaceutical companies are actively involved in the development and commercialization of ranibizumab biosimilars. The market is characterized by both established biosimilar manufacturers and originator companies introducing their own biosimilar versions. NDC 50419-0540 is associated with a specific ranibizumab biosimilar product.

Leading Manufacturers and Products:

• Samsung Bioepis Co., Ltd.: Known for its biosimilar portfolio, Samsung Bioepis has developed ranibizumab biosimilars.
• Amgen Inc.: A major biotechnology company, Amgen has also entered the ranibizumab biosimilar space.
• Viatris Inc.: Formed from the merger of Mylan and Upjohn, Viatris has a strong presence in the biosimilar market.
• Biosimilar Solutions Ltd.: While not a major global player, smaller entities contribute to market fragmentation and competition.
• Originator Companies: Some original developers of ranibizumab have also launched their own biosimilar versions to compete within the evolving market.

The introduction of multiple biosimilar candidates has intensified competition, leading to price erosion. The specific manufacturer and formulation associated with NDC 50419-0540 are critical for identifying its market position and competitive landscape.

What are the Approved Indications for Ranibizumab Biosimilars?

Ranibizumab biosimilars are approved for indications similar to the reference product, Lucentis. These approvals are based on demonstrated analytical, clinical, and non-clinical similarity to the originator biologic [4].

Approved Indications:

• Wet Age-Related Macular Degeneration (AMD): This is the primary indication, targeting the abnormal blood vessel growth in the retina that causes vision loss.
• Diabetic Macular Edema (DME): Treatment for swelling in the macula caused by diabetes, a leading cause of vision loss in diabetic patients.
• Macular Edema Following Retinal Vein Occlusion (RVO): Addressing vision impairment caused by blockages in retinal veins.
• Neovascular (Wet) Age-Related Macular Degeneration: A broader classification encompassing the wet form of AMD.

Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved several ranibizumab biosimilars, following rigorous review processes to ensure comparable safety, efficacy, and quality [5].

What is the Current Pricing Landscape for Ranibizumab Biosimilars?

The pricing of ranibizumab biosimilars is a critical factor in their market adoption. These products are typically priced at a discount to the originator biologic, Lucentis. The specific discount varies based on manufacturer, region, and negotiation with healthcare providers and payers.

Pricing Trends:

• Discount Range: Ranibizumab biosimilars have entered the market with discounts ranging from 20% to 40% compared to the originator's list price. This discount is expected to widen as more biosimilars gain market share [6].
• Impact of Competition: The presence of multiple biosimilars directly influences pricing. As more products receive approval and launch, price competition intensifies, leading to further reductions.
• Regional Variations: Pricing strategies differ across geographical markets due to varying healthcare reimbursement policies, market access negotiations, and competitive dynamics.
• NDC 50419-0540 Pricing: The price associated with NDC 50419-0540 is subject to market forces and the specific contractual agreements between its manufacturer and distributors or healthcare systems. Wholesale acquisition costs (WAC) for ranibizumab biosimilars are generally lower than Lucentis. For instance, initial launches of biosimilars in the US have seen WAC prices around $400-$500 per 0.5mg/0.5mL vial, whereas Lucentis previously had WACs exceeding $1,900 [7, 8].

What are the Future Price Projections for Ranibizumab Biosimilars?

Price projections for ranibizumab biosimilars indicate a continued downward trend, albeit at a moderated pace as the market matures and reaches equilibrium.

Projected Price Evolution:

• Short-Term (1-3 Years): Prices are expected to decline by an additional 10-20% as initial market penetration occurs and competition solidifies. Increased payer uptake and formulary inclusion will drive volume and further incentivize price reductions.
• Mid-Term (3-5 Years): Price stabilization is anticipated as the market consolidates and competition becomes more predictable. Discounts are likely to settle in the range of 40-60% relative to the originator's peak pricing.
• Long-Term (5+ Years): Prices may see marginal declines or remain relatively stable, reflecting manufacturing efficiencies and ongoing market dynamics. The focus will shift from aggressive price discounting to value-based propositions and therapeutic differentiation where possible.
• NDC 50419-0540 Projection: The specific price trajectory for the biosimilar associated with NDC 50419-0540 will depend on its market share, the competitive intensity from other biosimilars, and its manufacturer's pricing strategy. However, it is highly probable that its price will continue to be benchmarked against other ranibizumab biosimilars, reflecting the overall market price erosion.

The overall projected cost savings for healthcare systems and patients are substantial. For example, if a biosimilar achieves a 40% discount, a treatment course could see savings of thousands of dollars per patient annually.

What is the Regulatory Status and Outlook for Ranibizumab Biosimilars?

The regulatory landscape for biosimilars is robust and continuously evolving. Approval processes are designed to ensure that biosimilars are highly similar to their reference products in terms of quality, safety, and efficacy.

Regulatory Considerations:

• FDA and EMA Approvals: Numerous ranibizumab biosimilars have received marketing authorization from major regulatory bodies. For instance, Byooviz (Samsung Bioepis), Cequa (Sun Pharma/Viatris), and ranibizumab-nren (Amgen) are approved in the U.S. [9].
• Interchangeability Designation: In some regions, biosimilars may seek an "interchangeable" designation, allowing them to be substituted for the reference product by a pharmacist without prescriber intervention. This designation requires additional data demonstrating that switching between the biosimilar and reference product does not increase the risk in terms of safety or diminished efficacy.
• Global Harmonization: Efforts towards global harmonization of biosimilar regulatory guidelines are ongoing, facilitating broader market access and reducing duplication of efforts for manufacturers.
• Post-Market Surveillance: Rigorous post-market surveillance is mandated to monitor the long-term safety and effectiveness of approved biosimilars.

The regulatory outlook remains positive, with continued support for biosimilar development and market entry. This stability is crucial for ongoing investment in the ranibizumab biosimilar space.

What are the Market Access Challenges and Opportunities?

Gaining broad market access for ranibizumab biosimilars involves navigating complex healthcare systems, payer negotiations, and physician prescribing habits.

Challenges:

• Payer Reimbursement Policies: Negotiating favorable formulary placement and reimbursement rates with private payers and government health programs can be challenging.
• Physician Adoption: Convincing physicians to switch from the established reference product to a biosimilar requires evidence of comparable outcomes and cost-effectiveness. Physician education and trust in biosimilarity are paramount.
• Pharmacy Benefit Managers (PBMs): PBMs play a significant role in drug formularies and can influence biosimilar uptake through preferred placement or rebates.
• Contractual Agreements: The terms of contracts between manufacturers, distributors, hospitals, and clinics can impact the accessibility and pricing of biosimilars.

Opportunities:

• Value-Based Agreements: Increasingly, payers are exploring value-based agreements that link payment to patient outcomes, offering an opportunity for biosimilars to demonstrate their economic value.
• GPO and Wholesaler Partnerships: Collaborating with Group Purchasing Organizations (GPOs) and major wholesalers can ensure wider distribution and access within hospital networks and retail pharmacies.
• Patient Assistance Programs: Implementing robust patient assistance programs can mitigate out-of-pocket costs, enhancing affordability and access.
• Real-World Evidence (RWE): Generating and disseminating RWE demonstrating comparable efficacy and safety in real-world clinical practice can bolster physician confidence and payer acceptance.

Key Takeaways

The ranibizumab biosimilar market, represented in part by NDC 50419-0540, is poised for substantial growth. Key drivers include the rising incidence of ocular diseases and the cost-effectiveness of biosimilars. Multiple manufacturers are competing, leading to price erosion and significant cost savings. Projections indicate continued price declines in the short to mid-term, followed by stabilization. Regulatory pathways are well-established, supporting biosimilar approvals. Market access is contingent on navigating payer policies and physician acceptance, with opportunities arising from value-based agreements and RWE generation.

Frequently Asked Questions

1. What is the primary therapeutic area for ranibizumab biosimilars? The primary therapeutic area is ophthalmology, specifically for conditions like wet age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO).

2. How does the price of a ranibizumab biosimilar compare to the reference product, Lucentis? Ranibizumab biosimilars are priced at a discount, typically ranging from 20% to 40% initially, with projections for further reductions up to 60% of the originator's peak pricing.

3. What does NDC 50419-0540 signify in the context of ranibizumab biosimilars? NDC 50419-0540 is a National Drug Code that identifies a specific ranibizumab biosimilar product, including its manufacturer, strength, and dosage form, differentiating it from other ranibizumab products.

4. Are ranibizumab biosimilars considered interchangeable with Lucentis? Some ranibizumab biosimilars may seek or have obtained an interchangeable designation in specific regulatory jurisdictions, allowing for pharmacist substitution, though this is not universally granted or applicable.

5. What factors will influence the future price trajectory of ranibizumab biosimilars? Future pricing will be influenced by the number of biosimilars in the market, their respective market shares, ongoing competition, payer negotiations, manufacturing costs, and the overall demand for these treatments.

Citations

[1] Grand View Research. (2023). Ranibizumab Biosimilar Market Size, Share & Trends Analysis Report By Indication, By End-use, By Region, And Segment Forecasts, 2023 – 2030. [2] World Health Organization. (2021). Blindness and vision impairment. [3] U.S. Food & Drug Administration. (2020). Biosimilar Basics. [4] European Medicines Agency. (2021). Biosimilar medicines: Key principles. [5] U.S. Food & Drug Administration. (2023). Biosimilar Approved Products. [6] IQVIA. (2022). Global Outlook for Biosimilars. [7] GoodRx. (2023). Lucentis Prices, Coupons & Patient Assistance Programs. [8] Manufacturers' Press Releases and Public Filings. (Data compiled for individual biosimilar launches, e.g., Amgen, Samsung Bioepis). [9] U.S. Food & Drug Administration. (2023). Biosimilar Approved Products. (Specific product names and manufacturers listed).