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A Bengaluru-based biotechnology company had developed a trastuzumab biosimilar (anti-cancer monoclonal antibody) and received DCGI approval for the Indian market. They wanted to commercialise the biosimilar in EU where the reference product (Herceptin by Roche) had patent expiry in multiple EU markets. EU biosimilar MA via EMA centralised procedure was estimated to cost EUR 2-4M and take 3-4 years.
AJG identified a mid-sized EU specialty pharma company with existing oncology distribution networks across Germany, France, Italy, and Spain seeking a biosimilar development partner. A co-development and licensing agreement was structured: EU partner would fund 60% of EU regulatory costs in exchange for exclusive EU distribution rights; Indian manufacturer retained full ex-EU rights. EMA Scientific Advice meeting was arranged jointly to validate the regulatory pathway before major expenditure commitments.
Co-development agreement signed within 8 months of AJG mandate commencement. EMA Scientific Advice received positive guidance. EU clinical programme initiated. Expected EU MA in 36 months. Deal terms: EUR 3M upfront payment to Indian manufacturer plus royalties of 12-18% on EU net sales. Expected annual royalty income post-launch: EUR 2-4M based on market projections.
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