Sargramostim Biosimilar Licensing Opportunity
Phenotypeca’s recombinant sargramostim biosimilar offers governments and militaries affordable access to a critical therapy for Acute Radiation Syndrome (ARS), enabling rapid response in the event of nuclear attack or accident. Developed using our proprietary QTL strain optimisation platform, the biosimilar delivers reliable, high-quality production with low batch variability, improved scalability, and reduced manufacturing cost—key advantages for national stockpiling strategies.
Use Case & Relevance
Sargramostim is the only FDA-approved therapy for ARS that remains effective longer than 24 hours after radiation exposure. It has been shown to outperform alternatives in restoring platelets and multiple immune cell types, reducing haemorrhage, and improving anaemia. It is effective without the need for transfusion. Continuing viability when administered more than 24 hours after radiation exposure is a critical requirement to comply with military operational procedures devised for a nuclear attack.
Key Advantages
- Bioequivalence
- Reliable, scalable production
- Low glycoprofile variability and batch-to-batch consistency
- High-yield strain optimised for industrial manufacture
- Cost-effective for large-scale stockpiling
- Backed by validated clinical use and deployment scenarios
Supply & Licensing Options
Territory-based licensing is available for manufacturing and/or distribution. Alternatively, Phenotypeca can supply the biosimilar API or finished product directly to qualified public sector or military customers under agreed terms.
Regulatory Position
All patents relating to sargramostim API, formulation, and its use in ARS treatment have expired. In certain jurisdictions, stockpiling for defence or emergency preparedness may proceed without local regulatory approval under military procurement exemptions. This pathway already exists in several European defence bodies including the UK although some validatory testing may be requested.
Technical Status
- Research samples available for validation
- Analytical data will be available confirming match to the reference product
- Fermentation supernatant available to confirm titre and consistency
Intellectual Property
Phenotypeca’s QTL patents protect key genetic alleles essential for high-yield biosimilar production. This prevents competitors from replicating our production strain or developing functionally equivalent alternatives based on the same loci.