TSY-110 - Kadcyla (T-DM1) Biosimilar

 

Model: TSY-110

Category: Biosimilars

Exhibitor: FORMOSA PHARMACEUTICALS , INC

Booth No: M318

 

Characteristic

 

√ TSY-110 is a biosimilar of the antibody-drug conjugate (ADC) Kadcyla® (ado-trastuzumab emtansine), the first approved ADC therapy for treating HER2-positive early-stage and metastatic breast cancer.
√ Originally developed and globally marketed by Roche and Genentech, Kadcyla® generated approximately USD 2.5 billion in global sales in 2025. TSY-110 is currently the only known Kadcyla® biosimilar in development specifically targeting the U.S. and European markets.
√ Successful BPD Type II meeting with the US Food and Drug Administration (FDA) in 2026, confirming trial design and CMC strategy.
√ TSY-110 is in IND-enabling stage, with clinical trials expected to initiate in 2026. Formosa Pharma is actively seeking regional or global licensing partners interested in co-developing or commercializing this promising biosimilar asset.

 

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