CEO Executive AssistantBiosimilar competition strategy CEO engagement requires a different mindset than most competitive responses in pharma. When a biosimilar enters your market, you are not competing with an inferior product – you are competing with a structurally similar product at a significantly lower price, backed by a regulatory framework that is specifically designed to erode your market share. The question is not whether biosimilar erosion will happen. It is whether you have made the right strategic choices to preserve the value of your franchise and to position your portfolio for the post-reference-product era.
CEOs who approach biosimilar competition reactively – cutting price defensively, fighting every patent dispute, and extending marketing programs for products whose commercial life is predictably limited – consume enormous organizational energy with limited strategic return. Those who approach it proactively, with a clear lifecycle management strategy and a realistic assessment of the commercial opportunity, preserve more value and invest their energy more productively.
The CEO’s Stake in Biosimilar Strategy
Biosimilar competition typically affects the largest-revenue products in a pharma or biotech portfolio. The CEO’s engagement in biosimilar strategy is warranted because these decisions affect the company’s overall financial trajectory, its portfolio investment priorities, and its commercial organization’s focus.
The specific decisions where CEO ownership is appropriate:
- How much capital should we invest in defending the reference product versus accelerating the next-generation pipeline?
- What is our pricing strategy as biosimilars enter – hold price and accept volume erosion, or reduce price to compete for retained volume?
- Is a proprietary biosimilar strategy appropriate for our portfolio, and if so, which products and which markets?
- How do we communicate the biosimilar entry to investors in a way that maintains confidence in the company’s financial trajectory?
These are board-level and CEO-level questions. They should not be resolved by the commercial team acting autonomously.
Strategic Time Investment Before Biosimilar Entry
The most valuable CEO time investment in biosimilar competition comes three to five years before the first biosimilar entry – when the lifecycle management decisions are still open. This is when the strategic options are widest and the organizational energy required to pursue them is lowest.
Lifecycle Management Planning
For every major biologic product in your portfolio, you should have a lifecycle management strategy that addresses the biosimilar horizon explicitly. This strategy should cover:
- Formulation improvements that provide genuine clinical benefits (subcutaneous reformulation of IV products, extended-release formulations, auto-injector development) and that justify new IP protection and clinical differentiation
- Label expansion into new indications or patient populations where the biosimilar may not immediately follow
- Patient support and adherence programs that create switching costs for patients who benefit from your product’s specific delivery features or patient services
- Real-world evidence programs that document your product’s outcomes advantage in specific patient segments
These are investment decisions that require CEO sign-off because they require sustained capital allocation in competition with pipeline investment. Build biosimilar lifecycle planning explicitly into your pipeline review cadence, ensuring that marketed product management receives the same rigorous strategic review as development programs.
Next-Generation Product Strategy
The most durable response to biosimilar competition is a next-generation product that offers genuine clinical advancement over the reference product: improved efficacy, better safety profile, more convenient administration, or a differentiated mechanism in a related indication. Your pipeline should include specific programs that address the clinical unmet needs that your reference product leaves unmet.
This is not a defensive strategy – it is a business model. Companies with strong next-generation products convert biosimilar disruption into a commercial transition, retaining the patient population on a product that payers have clear reason to prefer over the lower-cost biosimilar.
When Biosimilar Entry Is Imminent
As biosimilar entry becomes imminent (12 to 18 months out), the CEO’s engagement shifts to operational readiness. Three specific priorities deserve direct CEO attention:
Commercial Organization Transition Planning
Your commercial organization has been built around your reference product. As biosimilars enter, the commercial model for that product changes: price discounting, hospital and payer contracting terms, and medical affairs support requirements all shift. Simultaneously, your pipeline may be preparing for commercial launches.
This is a commercial resource allocation question that requires CEO decision: how do you transition your commercial organization’s focus from a maturing branded product to new launches while managing the reference product’s decline? Budget a structured commercial planning review 12 to 18 months before biosimilar entry, covering the three-year transition plan and the resource implications.
Payer Contract Strategy
Your payer contracting strategy in the period surrounding biosimilar entry is one of the most consequential commercial decisions you will make. Net price agreements, rebate structures, and formulary positioning strategies are not independent decisions – they interact with biosimilar pricing dynamics and affect your product’s long-term market position.
This decision belongs in the CEO-led pricing governance process, not in commercial operations alone. Your CCO, Head of Market Access, and CFO should present a structured analysis of contracting strategy options before the first major contract renewal cycle that will be affected by biosimilar competition.
Investor Communication Planning
Investors who follow your company closely will be modeling your biosimilar exposure and the financial trajectory it implies. Proactive, credible investor communication about your biosimilar strategy – lifecycle management investments, next-generation pipeline, and realistic financial guidance – is a CEO responsibility. Analysts who develop their own biosimilar erosion models without CEO input from your strategy will typically model more conservatively than your actual planned outcomes.
The Biosimilar Strategy for Companies Entering the Biosimilar Space
Some pharma and biotech CEOs are making the opposite decision: entering the biosimilar market as a developer and commercializer rather than purely defending against biosimilar competition. This is a legitimate strategic option, particularly for companies with biologics manufacturing expertise and global commercial infrastructure.
The CEO’s time investment in a biosimilar strategy entry decision includes: evaluating the manufacturing capability requirements, assessing the target market economics in specific geographies (biosimilar profitability is highly geography-dependent), building the partnerships or acquisitions that address capability gaps, and managing the investor perception of a company that is simultaneously a branded biotech and a biosimilar developer.
This last point is nontrivial. Some investors view biosimilar activity as signal that your branded pipeline has insufficient future value. Others see it as smart capital deployment of manufacturing capacity. Your communication of the rationale needs to be clear, consistent, and defensible.
Managing the Organizational Response
Biosimilar competition creates organizational anxiety, particularly in commercial teams who see their product’s revenue declining and in R&D teams who worry about portfolio investment being redirected to lifecycle management rather than innovative programs.
The CEO’s communication role during a biosimilar transition is to provide a clear strategic narrative: this was anticipated, we have a plan, the plan includes both managing the transition and building the future. Annual state-of-the-company communications, internal all-hands sessions, and direct leadership team conversations all contribute to organizational clarity that is necessary for executing a complex biosimilar transition without losing the talent you need.
Managing regulatory dimensions throughout the lifecycle management and biosimilar entry period requires close engagement with your regulatory team. Your regulatory timeline management processes for lifecycle management submissions and for any patent dispute regulatory interactions should have defined CEO touchpoints.
Conclusion
Biosimilar competition strategy CEO leadership is most effective when it starts early, is grounded in realistic financial and competitive modeling, and produces clear decisions about investment priorities that the organization can execute with confidence. CEOs who engage in this proactively – before the biosimilar clock becomes urgent – preserve far more value than those who fight every aspect of biosimilar entry defensively. The executives who succeed in the biosimilar era are those who have built next-generation programs while protecting their reference product’s patient population through genuine clinical differentiation, and who have communicated this strategy credibly to investors, employees, and payers well in advance.
Related Reading
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