Introduction
The pharmaceutical industry is a complex and dynamic sector, influenced by various factors such as regulatory changes, market demand, and technological advancements. This article will focus on the market analysis and price projections for the drug identified by the National Drug Code (NDC) 83257-0012, specifically Ogivri® (trastuzumab-dkst), a biosimilar of Herceptin.
Understanding the National Drug Code (NDC)
The NDC 83257-0012 is associated with Ogivri®, a product of Biocon Biologics Inc. This code is part of a recent update where the ownership of Ogivri® and another product, Fulphila®, was transferred from Mylan Institutional LLC (a Viatris company) to Biocon Biologics Inc., resulting in new NDC numbers[1].
Product Description
Ogivri® (trastuzumab-dkst) is a biosimilar of Herceptin, used in the treatment of certain breast cancers. The specific product with NDC 83257-0012 is a 420 mg/vial multiple-dose vial, accompanied by bacteriostatic water for injection[1].
Current Industry Trends
Global Pharmaceutical Market Growth
The global pharmaceutical market is expected to experience robust growth, driven by an ageing population and emerging markets. Regions like Asia Pacific and the Middle East are forecasted to have the largest annual growth rates, particularly for specialty products and generic drugs[2].
US Pharmaceutical Market
In the United States, pharmaceutical output is projected to increase by 2.9% in 2024 and 2.5% in 2025. This growth is driven by an ageing population and a growing need for medications, including those for chronic conditions and weight management[2].
Pricing and Cost Trends
The US pharmaceutical market is characterized by high prices compared to other regions. The average price per unit in the US is significantly higher than in other OECD countries and the rest of the world. This disparity is partly due to the mix of drugs in the US, which tends to include more expensive compounds[2].
Impact of Regulatory Changes on NDC Numbers
Transition to New NDCs
The transition to new NDC numbers for Ogivri® and Fulphila® does not signify any change in the product form, strength, or composition. Biocon Biologics will treat each new NDC the same as the corresponding old NDC with respect to pricing and purchasing under the 340B program[1].
FDA's NDC Number System
The FDA is facing a critical issue with the NDC number system, as it is running out of available numbers. This necessitates a significant overhaul of the current system, which will impact various aspects of the pharmaceutical supply chain. However, this change does not directly affect the pricing or availability of Ogivri® under the new NDC 83257-0012[2].
Market Analysis for NDC 83257-0012
Drug Identification
Ogivri® (trastuzumab-dkst) is a biosimilar of Herceptin, used in the treatment of HER2-positive breast cancer. The market for biosimilars is growing as they offer cost-effective alternatives to biologic drugs.
Pricing Factors
The price of Ogivri® is influenced by several factors, including production costs, market demand, and competition. As a biosimilar, Ogivri® benefits from lower production costs compared to the original biologic, Herceptin. The Wholesale Acquisition Cost (WAC) for Ogivri® 420 mg/vial is $2,625.05, which is significantly lower than Herceptin[1].
Demand and Supply Dynamics
The demand for Ogivri® is driven by the need for effective treatments for HER2-positive breast cancer. As the population ages and the incidence of cancer increases, the demand for such treatments is expected to rise. The supply is influenced by the production capacity of Biocon Biologics and the distribution network[2].
Competitive Landscape
The competitive landscape for biosimilars is dynamic, with new entrants in the market. However, Ogivri® benefits from being one of the early biosimilars approved for Herceptin, giving it a market advantage. Government regulations aimed at reducing drug prices can also influence market dynamics, but biosimilars generally offer a more cost-effective option[2].
Price Projections
General Trends
Given the overall trends in the pharmaceutical industry, prices for biosimilars like Ogivri® are likely to remain stable or decrease slightly due to competition and regulatory efforts to reduce drug costs. However, the high demand for cancer treatments may maintain or slightly increase prices in the short term[2].
Specific Projections for NDC 83257-0012
For Ogivri® (NDC 83257-0012), the price is expected to remain stable around $2,625.05 per vial. The transition to the new NDC does not affect the 340B pricing, which will remain the same as for the old NDC. This stability is crucial for covered entities and patients relying on this medication[1].
Example of Biosimilar Pricing
Biosimilars like Ogivri® have significantly lower prices compared to their biologic counterparts. For instance, Herceptin's prices can be several times higher than Ogivri®. This pricing difference is a key factor driving the adoption of biosimilars in the market[2].
Key Takeaways
- Regulatory Stability: The transition to new NDC numbers does not affect the pricing or availability of Ogivri®.
- Market Demand: The demand for Ogivri® is driven by the need for effective breast cancer treatments.
- Pricing Trends: Prices for biosimilars are expected to remain stable or decrease slightly due to competition and regulatory efforts.
- Competitive Advantage: Ogivri® benefits from being an early biosimilar approved for Herceptin, giving it a market advantage.
- Global Growth: The global pharmaceutical market, including the biosimilar segment, is expected to grow robustly.
FAQs
What is the NDC 83257-0012 associated with?
The NDC 83257-0012 is associated with Ogivri® (trastuzumab-dkst), a biosimilar of Herceptin, specifically the 420 mg/vial multiple-dose vial.
Why are the NDC numbers for Ogivri® changing?
The NDC numbers for Ogivri® are changing due to the transfer of ownership from Mylan Institutional LLC (a Viatris company) to Biocon Biologics Inc.
Will the pricing for Ogivri® change with the new NDC?
No, the pricing for Ogivri® under the new NDC will remain the same as for the old NDC, including the 340B pricing[1].
What factors influence the price of Ogivri®?
The price of Ogivri® is influenced by production costs, market demand, competition, and regulatory environment.
How does the demand for Ogivri® impact its market?
The demand for Ogivri® is driven by the need for effective treatments for HER2-positive breast cancer, and it is expected to rise with an ageing population and increasing incidence of cancer.
Sources
- Biocon Biologics Inc. Notice Regarding Ogivri® & Fulphila® National Drug Code Numbers Update. HRSA, September 12, 2023.
- Market Analysis and Price Projections for the Pharmaceutical Industry: A Focus on NDC 00121-0852. Drug Patent Watch, December 31, 2024.
- 2025 Pharma Predictions: AI, Health Tech, and Data Trends to Watch. Intelligencia AI, December 19, 2024.
- National Drug Code Database Background Information - FDA. FDA, March 20, 2017.
