Trastuzumab Biosimilar (anti-HER2 monoclonal antibody)

Curated by Vinod Kumar Jain & Amit Jain · All Frontier Global · free, no login

Corridor

India-EU

Mandate Type

sell

Principal Type

seller

Incoterm

Ex-works licensing (not physical goods shipment)

Price Range

EUR 2-4M upfront + royalties; negotiable based on partner EU distribution reach and regulatory co-investment

Payment Terms

EUR 2-4M upfront licensing fee plus 12-18% royalties on EU net sales; milestones on EMA approval and first commercial sale

Frequency

one-time with royalties

Specification

Biosimilar to Herceptin (Roche); 440mg powder for concentrate for solution for infusion; analytical comparability with EU-sourced Herceptin demonstrated; Phase I PK/PD study in healthy volunteers completed (non-clinical package available); Indian DCGI approval obtained; manufacturing at EU GMP certified biopharmaceutical facility in Hyderabad (MHRA inspection 2023)

Notes

Seeking EU pharmaceutical partner to co-develop EMA centralised procedure marketing authorisation. Partner to contribute EUR 2M toward EU regulatory costs in exchange for exclusive EU distribution rights. Indian company retains all ex-EU rights. EMA Scientific Advice meeting already completed — positive guidance on development programme. Deal structure: licensing + supply agreement.

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