Last updated: February 15, 2026
What is the product associated with NDC 57237-0077?
NDC 57237-0077 corresponds to a specific drug product, identified by the National Drug Code (NDC). Based on publicly available FDA databases, this NDC is assigned to Renflexis (infliximab-abda), a biosimilar to Remicade, indicated primarily for autoimmune conditions like rheumatoid arthritis, Crohn's disease, and ulcerative colitis.
What is the current market landscape for infliximab biosimilars?
The biosimilar infliximab market has grown significantly since the first approvals in 2016. The entry of Renflexis has intensified competition, leading to considerable price erosion for the originator and biosimilar counterparts.
Key competitor landscape:
| Product |
Manufacturer |
Approval Date |
Indications |
Approvals in Major Markets |
| Remicade (infliximab) |
Janssen (Johnson & Johnson) |
1998 |
RA, Crohn's, UC, psoriasis, others |
US, EU, Japan |
| Renflexis (infliximab-abda) |
Samsung Bioepis/Celltrion |
2017 |
Same as Remicade |
US, EU, Japan |
| Similar biosimilars |
Various (e.g., Inflectra, Avsola) |
2016-2019 |
Same indications |
US, EU, Japan |
Market size estimates:
- The US infliximab market in 2022 was approximately $3.2 billion.[1]
- Biosimilars captured around 45% of infliximab prescriptions by volume in 2022, with prices averaging 25-40% lower than Remicade.[2]
Market drivers:
- Patent expiration of Remicade (2018 in the US, extended in some jurisdictions).
- Growing adoption among biologic-naïve and switching patients.
- Payer-driven formulary preferences favoring biosimilars.
What are the current pricing trends for NDC 57237-0077?
The retail price for Renflexis varies by distributor, payer discounts, and pharmacy networks. List prices are often reduced through rebates and negotiations.
| Date |
Average Wholesale Price (AWP) |
Estimated Net Price |
Notes |
| 2022 |
~$2,500 per 100 mg vial |
~$1,800 - $2,200 |
Payer discounts, rebates reduce net price by 20-30% |
| 2023 |
Slightly declining due to increased biosimilar competition |
~$2,300 per 100 mg vial |
Price erosion continued, driven by biosimilar entries |
Comparison to originator:
- Remicade's list price in 2022 was approximately $4,300 per 100 mg vial.[3]
- Biosimilars, including Renflexis, have reduced the average wholesale price by 40-50%.
What are projections for future pricing and market share?
Price projections:
- Biosimilar prices are expected to decrease by an additional 10-15% annually over the next five years.
- By 2028, the net price for infliximab biosimilars, including Renflexis, could stabilize around $1,600 per 100 mg vial, assuming continued competition.
Market share outlook:
- Biosimilars are projected to account for 60-70% of infliximab prescriptions by 2025.
- Prescriptions for Renflexis could reach 25-30% of the infliximab market in the US, supported by formulary placements and payer incentives.
What factors influence pricing and market dynamics?
- Patent litigation and exclusivity: Delays in biosimilar market penetration if patents extend beyond original approval.
- Regulatory policies: Policies promoting biosimilars (e.g., substitution laws) impact adoption.
- Rebate strategies: Originator companies offer rebates and discounts to retain market share.
- Manufacturing costs: Biosimilar production costs remain relatively stable but can influence pricing strategies.
- Market expansion: Entry into emerging markets and new indications can drive volume.
Summary of key insights:
- NDC 57237-0077 (Renflexis) faces declining prices driven by increased biosimilar competition.
- Current net prices range around $1,800-$2,200 per 100 mg vial in the US.
- The market share of biosimilars, including Renflexis, is expected to grow to over 60% within three years.
- Price erosion will likely continue, with an estimated further 10-15% annual decline over five years.
- Payer and formulary strategies heavily influence adoption and pricing dynamics.
Key Takeaways
- Renflexis's market share is increasing, impacting traditional infliximab pricing.
- Price projections show continued decline, driven by biosimilar competition and market saturation.
- The overall infliximab market is shifting toward biosimilars, which will compress margins.
- Policy and patent landscapes will significantly influence future market dynamics.
- Manufacturers and investors should monitor pricing trends, formulary policies, and patent statuses to assess risks and opportunities.
FAQs
1. What is the main competitive advantage of Renflexis?
Price competitiveness and formulary placement. Its lower price points often secure preferred status in managed care plans.
2. How do biosimilar prices compare to the originator?
Biosimilars typically list at 40-50% lower than Remicade, with net prices even lower after rebates.
3. Are biosimilar penetration rates consistent across markets?
No. US adoption exceeds 60%, whereas EU markets show varied rates due to different regulatory and reimbursement policies.
4. What barriers limit biosimilar market share?
Brand loyalty, patent litigations, and formulary preferences favoring originators can slow biosimilar uptake.
5. Will price erosion stabilize?
Likely, as the market matures and volume increases, prices may stabilize around $1,600-$1,800 per vial.
References
[1] IQVIA. (2022). US Oncology Market Review.
[2] EvaluatePharma. (2022). Biosimilar Market Trends.
[3] GoodRx. (2022). Infliximab Pricing Data.
