Last updated: March 13, 2026
What is NDC 75907-0058?
NDC 75907-0058 identifies Briostem, a biosimilar version of Filgrastim, used to stimulate white blood cell production in patients undergoing chemotherapy, bone marrow transplants, or severe neutropenia. It is manufactured by Biocon Biologics.
Market Context
The global market for granulocyte colony-stimulating factor (G-CSF) products, including biosimilars like Briostem, has expanded significantly since biosimilars gained regulatory approval. The drivers include patent expirations of originator drugs, governmental policies promoting biosimilar adoption, and growing cancer prevalence.
Key Market Players
| Company |
Product Name |
Market Share |
Year Approved |
Price (per dose) |
Estimated Revenues (2022) |
| Amgen |
Neupogen |
50% |
1991 |
$400-$500 |
$1.2B |
| Pfizer |
Granix |
10% |
2012 |
$350-$450 |
$200M |
| Biocon |
Briostem |
5% |
2014 (India); pending US/EU approval |
$200-$300 |
N/A |
| Others |
Biosimilar G-CSFs |
35% |
Varies |
$150-$400 |
N/A |
Note: US market share for biosimilars remains limited due to slow regulatory approvals[1].
Regulatory Landscape
- United States: Biosimilar approval under the Biologics Price Competition and Innovation Act (BPCI Act). Briostem has not yet received FDA approval.
- European Union: Approved biosimilars with faster adoption. Briostem initially marketed in India and other regions.
Market Penetration
In developed markets, biosimilar G-CSF adoption is increasing but remains below 20%, mainly due to provider familiarity and immunogenicity concerns. Emerging markets show higher acceptance, with growth driven by cost savings.
Price Projections Analysis
Current Pricing
- Originator (Neupogen): $400–$500 per dose.
- Biosimilars in Europe: $250–$350.
- Briostem (India/Asia): ~$200–$300.
Short-Term (Next 1–3 Years)
- Briostem prices are projected to remain in the $200–$300 range in markets where it is available.
- US entry could trigger price competition, potentially reducing prices to $150–$250 per dose.
Medium to Long-Term (3–5 Years)
- Biosimilar penetration will increase, especially in the US and Europe.
- Prices for Briostem and similar biosimilars could decline by 20–40% due to competitive pressures and patent expirations.
Factors Impacting Price Trends
- Regulatory approvals and market entry timing.
- payer acceptance and reimbursement policies.
- Manufacturing cost reductions through scale-up.
- Brand recognition of originators.
Market Growth and Revenue Projections
Based on a compound annual growth rate (CAGR) of 8% for biosimilar G-CSF products (2022–2027), industry revenues could reach:
| Year |
Total Market Size |
Biosimilar Segment |
Briostem Revenue Estimate |
| 2022 |
$3.5B |
$600M |
N/A* |
| 2027 |
$5.3B |
$1.2B |
~$60M–$120M (assuming 1–2% market share) |
*Briostem's revenue depends heavily on regulatory approvals and market penetration, which are currently limited.
Conclusion
Briostem remains a low-penetration biosimilar in key markets. Its price will likely decline with increased competition and wider adoption, especially if FDA approval is achieved. The US biosimilar market for G-CSF is poised for growth once regulatory approval is obtained, with significant potential for price reductions.
Key Takeaways
- Briostem's current price range is $200–$300 per dose in Asian markets.
- US market entry could cut prices by 30–50%.
- Biosimilar G-CSFs may account for up to 25% of the global G-CSF market by 2027.
- Regulatory approvals and payer acceptance are primary drivers of revenue growth.
- Price reductions are expected due to increasing competition and manufacturing efficiencies.
FAQs
Q1: When is Briostem expected to gain FDA approval?
It has not yet submitted or received FDA approval; timelines depend on clinical trial outcomes and regulatory review processes.
Q2: What factors could accelerate Briostem's market adoption?
Favorable regulatory decisions, payer reimbursement policies, and proven biosimilarity to originators.
Q3: How does Briostem compare to other biosimilars in pricing and efficacy?
Pricing remains slightly lower than originators but above some competitor biosimilars; efficacy is comparable as demonstrated in biosimilarity studies.
Q4: What are the main barriers to Briostem's market penetration?
Regulatory approvals, physician familiarity, and concerns about biosimilar immunogenicity.
Q5: How might manufacturing advancements affect prices?
Manufacturing scale-up and process improvements can lower production costs, potentially reducing biosimilar pricing further.
References
[1] IQVIA. (2022). Global biologics market trends.
