Biosimilar Erosion Driving Uptake of Process Intensification

Rhonda Duffy, chief operating officer of Biocon Biologics,advised delegates at the Sartorius PI Forum in India recently to treat the pursuit of intensified processes as a key lever in ensuring a biosimilar product is commercially viable.

Why Process Intensification Is Becoming Essential for Biosimilar Commercial Success

“When we first started in biosimilars, you could hope to get between 40 and 60% of the originator price,” she told the Hyderabad audience. “Now you start at 10% of the originator price and that price decreases 10% year on year. It's a price market that's going down; a complexity market that's actually increasing.”

A launch that once met three or four rivals can now reach double figures. AbbVie's Humira (adalimumab) was the industry's biggest seller for two decades, but when it lost US exclusivity in 2023, 10 biosimilar rivals entered the market within a year. In the first quarter of 2024, AbbVie reported US sales of Humira had fallen by around 40% year on year.

Shrinking Biosimilar Margins Increase Pressure to Lower Manufacturing Costs

Overall, the wider biosimilar market is still growing quickly, from $29.4 billion in 2023 to a projected $66.9 billion by 2028, but without lowering cost of goods sold (COGS) by implementing leaner intensified processes, it will be increasingly difficult to be competitive and for biosimilar makers to extract value.

“You know so much about how to make these products. Tell me how you can make them faster, cheaper and in a more agile way,” Duffy told the room. “That's really what my challenge would be in terms of how you're trying to support from a commercialization point of view because unless it's sellable, it's not actually going to be affordable by any of us ultimately.”

Biocon is well versed in biosimilar competitiveness. It grew from enzyme manufacturing into one of the world's larger biomanufacturers and a pioneer in the Indian and global biosimilar space, with 10 approved products.

Cycle Time and Working Capital Matter More Than Maximizing Titer

Duffy's commercial pressures track that footprint, with her argument to a room of process scientists being that the binding constraint is not titer but the working capital tied up in cycle time. A facility might turn out 10 to 14 batches a month, she said, “but if it actually takes 60 days to get that batch out of the system, that's a hell of a lot of money they have tied up in terms of actually getting my batches out the door, and I would much prefer that you can actually help me get them out the door far quicker.”

A viable cell count of 50 million harvested in six days instead of 100 million in twelve would be preferable, because a faster harvest frees the working capital a longer cycle ties up. Demand is no easier to plan around, she continued, recalling a US commercial team that doubled its order a month before launch.

Although cutting drug substance cost by 20% is an achievable and significant target that intensification can deliver, it still can take around 18 months to reach a patient. This is because it triggers six-month stability runs across every device format an originator carries—vial, prefilled syringe (PFS), cartridge, auto-injector—plus drug product stability. By the time it lands, Duffy noted, the market it was built for has often moved.

Building Intensified Processes Early Can Avoid Costly Delays

The way to sidestep much of that penalty is to design the leaner process in during development rather than bolt it on afterwards, because once a process is fixed at filing, later changes tend to trigger fresh studies and stability work. A biosimilar intensified from the outset, therefore, can reach the market without the retrofit and without the 18-month timeline.

Regulatory Changes Are Supporting More Flexible Biosimilar Development

Part of that delay is regulatory, but the good news is that regulators are finally catching up after years of caution.

“Literally in the last 18 months I can see that regulators are starting to understand this area a lot more,” Duffy said.

In October 2025, the FDA released draft guidance stating it would no longer automatically require comparative efficacy studies for biosimilars, simplifying biosimilarity studies and facilitating pharmacy-level substitution in a move toward a unified, data-driven approval pathway. The EMA published a parallel reflection paper in April 2025 considering waivers of comparative efficacy study requirements.

Germany brought pharmacy-level biosimilar substitution into effect in March 2024, further opening the European market. If anything, that easing raises the premium on manufacturing agility rather than lowering it.

With products reaching the market faster and fluctuating demand, the advantage falls to producers who can ramp output up or down as the market turns, the flexibility that intensified, single-use processes are built to provide. However, there does remain a gap between regulatory intent and operational reality.

In particular, Duffy said multi-market registrations carry divergent specifications: the EMA clears a change reasonably quickly under a pre-approval change management protocol, the FDA takes weeks to months longer, and the rest of the world lags further behind. With a single process and no second site, Biocon's products have to meet the tightest specification of any market they enter.

Commercialization Requires End-to-End Ownership and Supply Chain Agility

Underlying Duffy’s presentation was a direct challenge to the scientists in the room. The people who design these intensified processes, she argued, have to build them for the commercial reality of the market rather than the comfort of the lab.

Companies need to own a process all the way through to commercialization rather than hand it to manufacturing and walk away, something she described as throwing a “half-baked process over the wall” to production.

“You really need to own the process from the start to the finish…commercialization is the most important phase,” she said. “I know the R&D guys think that it's all nice blue skies and all the great stuff happens in the lab, but commercialization is going to pay the salaries and that's the one you need to actually be focused on all the time.”

She extended the same demand to her suppliers, stressing that agility must be built into the full supply chain. When a site runs out of 50 L single-use bags, she needs to know whether the replacements arrive the next day, rather than being left to wonder whether the order has even reached the vendor.

Within a forum built around the science of intensification and full of engineering prowess, Duffy reminded the room that what is needed to keep a biosimilar commercially alive is not just clever science, but fast and flexible processes.

“To be perfectly honest, I want agility more than I want really good science,” Duffy said.

About the Author

Dan Stanton, Editorial Expert, Sartorius.