When entering Europe, choosing between licensing and co-development is not just a deal-structure question.
It is a strategic decision that directly impacts regulatory pathways, market access, operational complexity, and long-term value creation.
For non-European companies—and even EU-based biotechs—this choice is often made too late or too generically, without fully accounting for the specific realities of the European landscape.
Licensing in Europe: Speed, Local Expertise, and Risk Transfer
In a licensing model, a local or regional partner takes responsibility for development, regulatory interactions, and commercialization in Europe (or specific countries such as France, Germany, or Italy), in exchange for upfront payments, milestones, and royalties.
When licensing is a strong fit in Europe
Licensing often makes sense when:
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You lack on-the-ground EU regulatory or market access expertise
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Your asset is scientifically de-risked but still requires complex HTA and pricing negotiations
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You want to accelerate entry into fragmented European markets
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You prefer to transfer operational and reimbursement risk
In countries like France, where pricing, reimbursement, and post-approval obligations are highly specific, a strong local partner can dramatically reduce time to access—and costly missteps.
The trade-offs
Licensing typically means:
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Limited influence on pricing and access strategy
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Reduced control over launch sequencing across EU markets
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Dependence on the partner’s prioritization
Once licensed, reversing strategic decisions is difficult, especially if early access or pricing positioning is suboptimal.
Co-Development in Europe: Control, Upside, and Structural Complexity
Co-development implies shared responsibility for development and often a split of commercial rights by geography or indication.
When co-development works well in the EU context
Co-development can be compelling when:
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The asset shows strong differentiation and clear clinical value
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You want to remain involved in EU development and access strategy
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You plan to build or retain a European presence
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The indication requires close alignment between clinical development and market access
In Europe, co-development can allow earlier integration of pricing, reimbursement, and real-world evidence strategies, which are often underestimated outside the region.
The trade-offs
Co-development in Europe adds layers of complexity:
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Shared governance across different regulatory cultures
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Slower deal execution
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Higher internal resource requirements
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Increased financial exposure
This model requires clear governance, realistic resourcing, and long-term commitment.
In Europe, the Asset Is Only Half the Equation
A frequent mistake is selecting a deal model based solely on the asset’s science.
In Europe, the right model also depends on:
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Country-specific access requirements (France ≠ Germany ≠ UK)
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Regulatory strategy across EMA and national agencies
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Pricing reference implications between countries
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Your ability to manage or outsource local obligations
In other words, the European system rewards anticipation—not correction.
Hybrid Models Are Often the Smartest Option
Many successful EU deals combine approaches:
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Co-development through early clinical phases
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Regional licensing by country or cluster
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Step-in or step-out options linked to data or access milestones
Flexibility is often more valuable than control on day one.
Final Thought
In Europe, licensing and co-development are not just financial decisions; they are market access decisions.
The best outcomes come from:
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Choosing the model that fits both the asset and the European reality
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Designing the structure before pivotal data—not after
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Aligning scientific ambition with regulatory and commercial feasibility
Planning a European strategy for your asset?
At Elliogen, we help pharma and biotech companies:
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Decide between licensing, co-development, or hybrid models
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Design France and EU-specific entry strategies
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Prepare assets for partnering, launch, or value inflection
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Avoid costly missteps in market access and governance
👉 Get in touch to discuss your asset and European options
Whether you are pre-clinical, clinical-stage, or preparing a deal, an early strategic conversation can save years and preserve value.
hello@elliogen.com
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