Biosimilars have long held the promise of expanding access to biologic medicines.
Today, that opportunity is becoming more significant as ageing populations, rising rates of chronic disease and growing demand for long-term biologic treatments place greater pressure on healthcare systems.
For biosimilar manufacturers, the challenge is increasingly moving from development to scale. Bringing more biosimilars to market requires manufacturing processes that can deliver the necessary productivity, consistency and quality while helping control cost of goods.
The challenge is no longer simply how to bring more biosimilars to market. It is how the industry can manufacture them efficiently and reliably enough to deliver on their potential at scale.
As Andrea Wegner Senior Regulatory Director, Ecolab Life Sciences explains, the opportunity extends well beyond accelerating development.
“The real opportunity with biosimilars is broader access. As regulatory pathways continue to evolve, we have an opportunity to bring more biosimilars to patients, but we also have to make sure the manufacturing environment can support that growth reliably and at scale.”
Andrea Wegner, Senior Regulatory Director.
That is shifting the conversation. As regulatory pathways evolve and barriers to development are reduced, greater attention is turning towards what happens next: making manufacturing more productive, controlling cost of goods and maintaining consistency as processes move between sites, regions and commercial scales.
How changing regulation is reshaping biosimilar development
Regulators are placing greater emphasis on analytical and pharmacokinetic data as part of the biosimilar approval pathway, alongside work to simplify development requirements and support wider adoption.
For manufacturers, these developments could help create more efficient routes through development. But regulatory progress is only one part of the equation.
“The regulatory environment has evolved as our scientific understanding and experience with biosimilars has developed,” says Andrea. “The important question now is how we translate that progress into greater access. More efficient development can help, but it needs to be supported by manufacturing capabilities that can deliver consistent quality at commercial scale.”
In other words, more efficient development needs to be matched by equally effective manufacturing.
Balancing cost, quality and consistency in biosimilar manufacturing
This becomes particularly important as manufacturers move from development into commercial production.
Cost pressure is a fundamental part of the biosimilars market. Manufacturers need to control cost of goods to remain competitive, but achieving that cannot come at the expense of quality or process consistency.
For Tony Thomas of Ecolab Life Sciences, this balance is one of the recurring themes he sees in conversations with manufacturers.
“Manufacturers want greater efficiency, but they also need predictability. When you move from development into commercial manufacturing, consistency becomes critical. The process needs to continue performing as volumes grow and, increasingly, as it moves between sites and regions.”
Tony Thomas, Director, Field Application Scientists
The companies best positioned to succeed will therefore be those that can find efficiencies without introducing additional complexity, variability or risk.
Rather than efficiency and reliability being competing priorities, the goal is to design manufacturing processes capable of delivering both.
Where manufacturing and purification innovation can make a difference
That same principle is influencing where manufacturers see value in innovation.
The most meaningful advances are not necessarily those that introduce the greatest amount of change. Often, they are the technologies that enable an existing process to work more effectively.
“We’re seeing manufacturers look very closely at where they can improve productivity without adding another layer of complexity,” says Tony. “There’s real value in technologies that can help increase throughput or reduce processing time while fitting into the process a manufacturer already understands.”
Purification and downstream processing are areas where these productivity gains can become particularly important in biosimilar manufacturing. Chromatography is a critical part of downstream processing, and improvements in resin performance can influence throughput, processing time and manufacturing economics.
Advances in chromatography resin technology, including higher binding capacities and faster flow rates, can create opportunities to process greater volumes while reducing processing time, resin requirements or the number of cycles needed.
But technical performance alone does not determine whether an innovation will deliver value in a manufacturing environment.
“Innovation becomes much more meaningful when it improves the process without forcing the manufacturer to rethink everything around it.”
Tony Thomas
Compatibility with existing workflows matters. A technology that improves one process step but adds complexity elsewhere may simply move the problem. The greater opportunity is to improve productivity while minimising unnecessary process redesign or additional capital requirements.
Managing scale-up and technology transfer in biosimilar manufacturing
For manufacturers progressing towards commercial production, predictability becomes just as important as outright performance.
A process needs to remain consistent as it scales. It may also need to be transferred between manufacturing locations operating under different regulatory and operational conditions.
That puts greater emphasis on process understanding and practical technical support, particularly during scale-up and technology transfer.
As Tony explains, “Technical performance is obviously important, but manufacturers also need confidence that a process will behave predictably when circumstances change. That becomes especially important during scale-up or technology transfer, where problems can quickly translate into delays.”
Decisions around process design, materials and purification technologies therefore need to account not only for immediate performance, but also for how the process will operate in a commercial manufacturing environment.
That is where the economics and operational reality of biosimilars meet.
Scaling biosimilars to support greater global access
The remaining challenge is larger than any individual manufacturing step.
Manufacturers, regulators and technology partners each influence how effectively biosimilars move from development to patients. As manufacturing becomes increasingly global, greater consistency between sites and resilient supply will also become important considerations.
For Andrea, the next phase therefore requires the industry to connect regulatory progress with the practical realities of manufacturing.
“The next phase of biosimilar growth will depend on how effectively we turn scientific and regulatory progress into reliable supply. Ultimately, success should be measured by whether we can translate that progress into broader access for patients.”
Andrea Wegner
That puts collaboration at the heart of the industry’s next phase. Regulatory expertise, manufacturing knowledge and technology innovation need to work together rather than be considered separately.
The biosimilars opportunity is ultimately an access opportunity. Regulatory evolution can help reduce barriers to development, but sustainable global access also depends on what happens inside the manufacturing process.
The next frontier for biosimilar manufacturing is therefore not simply producing more. It is finding better ways to scale, making processes more productive and predictable while maintaining the consistency and quality on which patients ultimately depend
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