Winning in Biosimilars: Speed, Scale, and the New Competitive Playbook
Chime Vision | Issue 2
Summary
• Biosimilars are entering a breakout growth phase, projected to reach ~€180B by 2035
• CES waivers are transforming the economics of entry—reducing cost and time barriers
• As a result, competition is accelerating, reshaping the landscape and redefining how companies win
• In this new environment, leaders will not be those with the most capabilities, but those who combine focus with the right partnerships for end-to-end development and supply, to move faster, scale smarter, and capture value ahead of the market
A Market Opening, But Not for Long
For years, entering the biosimilars market required significant capital and technical expertise, keeping many potential players on the sidelines.
Recent developments, enabling faster and more cost-efficient development, have opened a rare window of opportunity that many will seek to capture.
The question is no longer whether to enter, but how to do so effectively.
Biosimilars Enter the Acceleration Era
After nearly two decades of regulatory development and growing clinical confidence, the biosimilars industry has reached scale. More than 90 biosimilars are approved in Europe[1] and over 60 in the United States[2], with global sales expected to exceed €30 billion in 2025.
Yet the trajectory ahead is far more significant, with projections reaching ~€180 billion by 2035.
This marks a shift from foundation-building to acceleration, where biosimilars evolve from alternatives to standard components of care.
What Is Driving the Shift
Several forces are converging to reshape the biosimilars landscape:
- Scientific confidence built through years of real-world evidence
- Increasing pressure on healthcare systems to reduce costs
- A major patent cliff unlocking new opportunities
- Regulatory evolution, particularly around CES waivers, lowering barriers to entry
Among these, CES waivers are arguably the most impactful.
CES Waivers: Redefining the Economics of Entry
The increasing acceptance of CES waivers marks a structural shift in biosimilar development.
Historically, regulators required head-to-head Phase III studies comparing biosimilars to reference biologics, resulting in lengthy (7–8 years) and costly (€150M–€200M) development processes [1].
However, advances in analytical methods and robust Phase I PK studies have demonstrated strong predictive power.
By enabling CES waivers, regulators are aligning requirements with scientific evidence, allowing developers to:
- Shorten development timelines by 2–3 years, and
- Reduce development costs by approximately 50%
This shift fundamentally expands access to the biosimilars market.
A Broader Competitive Landscape
As barriers fall, biosimilars are no longer the exclusive domain of global biopharma with the required know-how and capital. New players are expected to enter the field, including local/regional biopharma and generic pure-play players.
Previously, only blockbuster biologics justified investment, leaving many assets without biosimilar competition.
According to IQVIA, only 14 of 62 biologics without patent protection as of the end of 2024 in the US have biosimilars [2].
With more favorable economics, a wider range of targets opens with potential to increase savings and patient access.
A New Paradigm: Competing on Speed and Discipline
As competition increases, the recipe for success is changing.
- The traditional model of full vertical integration is giving way to a more flexible, execution-driven approach. In this new paradigm, three factors are becoming decisive:
- Speed to Market: Faster development enables earlier entry and stronger positioning
- Portfolio Strategy: Lower costs allow companies to pursue multiple assets, increasing resilience
- Operational Excellence: Companies focus on core strengths while leveraging external expertise.
In this context, execution discipline becomes the primary differentiator.
What It Takes to Win
For new entrants, these shifts translate into a clear set of strategic requirements.
To compete effectively, companies need to:
• Design fast, cost-efficient development programs
• Scale across multiple assets rather than rely on single-product bets
• Ensure global regulatory alignment from early stages
• Secure reliable, high-quality supply across clinical and commercial phases
Meeting these requirements internally can be complex and resource-intensive, making external capabilities increasingly critical.
Enabling the Next Wave of Biosimilar Leaders
In this environment, partnerships are becoming central to operating models.
Companies increasingly rely on CDMOs with proven expertise to combine speed, cost efficiency, and quality.
Chime Biologics (CBL) illustrates this model, offering integrated development and manufacturing capabilities with a focus on rapid execution and efficiency.
This approach enables faster development, earlier market entry, and more competitive cost structures.
Conclusion: Competing in a Market Defined by Speed
The biosimilars market is entering a phase of rapid expansion and intensifying competition.
Established players will need to adapt to increased price pressure and shorter product lifecycles, shifting from single-asset strategies to portfolio-based approaches.
At the same time, new entrants will seek to capture this opportunity by leveraging commercial strengths while externalizing biologics expertise.
Success will depend not on full vertical integration, but on making the right strategic choices, building the right portfolios and partnering effectively to execute at speed.
[1] IQVIA, The Impact of Biosimilar Competition in Europe, January 2026
[2] IQVIA, Assessing the Biosimilar Void in the US, February 2025
About Chime Biologics
Chime Biologics is a leading global CDMO, focused on ensuring our customers' success in delivering innovative biologics as well as biosimilars to patients across the world. Chime Biologics can support customers end to end, from pre-clinical support and cell line development through to clinical and commercial manufacturing of drug substance and drug product. Employing our state-of-the-art capabilities in our Europe Innovation Hub (Basel, CH), China Innovation Hub (Shanghai, CN), Development & Manufacturing Campus (Wuhan, CN) and proven success in supporting our clients with their clinical and commercial authorizations across the globe, Chime Biologics is a true end-to-end solution provider for the biologics industry. With over 600 skilled employees, we share a common goal to make cutting-edge biologics affordable and accessible to patients worldwide, fulfilling our commitment to improving human health globally.
