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Semaglutide

 

Semaglutide Biosimilar Licensing Opportunity


Phenotypeca’s biosimilar semaglutide offers licensing partners a fast and competitive route into the multibillion-dollar global market for GLP-1 receptor agonists used in obesity and diabetes care. Developed using our proprietary QTL strain optimisation platform, this semi-recombinant product consistently delivers the highest-quality semaglutide matched to the reference standard required for regulatory approval. Our unique manufacturing approach enables cost-effective large-scale production at an industrial scale.

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Market Context


Global semaglutide sales exceeded $13 billion in 2023 and continue to rise, driven by demand despite high pricing. With the expected introduction of biosimilars, market access will expand, particularly through public sector and insurance-funded reimbursement.

Phenotypeca’s biosimilar combines regulatory-grade quality with low-cost semi-recombinant manufacturing, enabling aggressive pricing strategies to rapidly gain market share. Even at 50% discounts to current pricing, this product supports strong gross margins.

 

Key Advantages


  • Exact reference standard match, validated by analytics
  • Scalable for high-volume global markets
  • Consistent, high-quality output across batches
  • High-yield yeast strain developed via QTL optimisation
  • Free from legacy process patent restrictions
  • Lower cost and superior scalability compared to synthetic approaches
  • IP-protected QTL architecture blocks competitor strain replication

 

Licensing Structure


Territory-specific licensing is available on an exclusive or non-exclusive basis with standard commercial terms. Phenotypeca offers support for in-house manufacturing scale-up or can provide ongoing API supply under agreed terms.

 

Technical Status


  • Precursor samples available for validation
  • API samples available pre-licensing
  • Full analytics confirming reference standard equivalence
  • Fermentation data validating yield
  • Under-license strain available for technology transfer and scale-up

 

Intellectual Property


Phenotypeca’s patents protect key Quantitative Trait Loci (critical genetic alleles) essential for scaled biosimilar manufacture. The patent landscape has been reviewed to ensure freedom to operate. Key composition-of-matter and process patents in major territories are set to expire by 2026.

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