Organized by FT Live, in collaboration with Endpoints News, the US Pharma and Biotech Summit 2026 brought together leading executives and experts in biopharma. They discussed how to navigate – in both the US and worldwide – the path from innovation to access amid an evolving landscape around policy, regulation, and investment.

Gillian Woollett, VP and Head of Regulatory Strategy and Policy at Samsung Bioepis, took part as a fireside chat speaker. Discussing the topic, “Sustaining the Biosimilar Market: Competition, Access, and Supply,” she pointed out current industry hurdles in closing the biosimilar void.

Here are some of the highlights.

Competition: Barriers to Biosimilar Market Entry

“There’s 90% of the biologics facing loss of exclusivity in the next 10 years with no apparent biosimilar in development. That’s a bad situation.”

Reports by Boston Consulting Group, McKinsey and American Health & Drug Benefits show that biosimilars cost about $100–300 million to develop on average.

Such development costs are incompatible with pricing policies that push biosimilar prices lower than natural market competition, creating a commercial environment that looks less attractive to both manufacturers and investors. Consequently, biosimilar manufacturers tend to target blockbuster brands as reference products to be safe, while generics are made as soon as a brand goes off patent.

This is a major contributing factor to the biosimilar void.

Access: Innovating Treatment Options for Patients

“We want that innovation. We want that next generation of brand. And we heard there's plenty of innovation to go around if we can see it through to patients.”

Considering the time and cost it takes to develop a biologic medicine, manufacturing capacity is finite. This applies to both reference products and biosimilars.

However, we need more biosimilars to accelerate the development of next-generation treatments. As we’ve covered in a previous issue, biosimilar competition sparks the virtuous cycle. This widens two points of access for patients: a broader selection of lower-cost treatment alternatives, and faster access to more innovative solutions.

It’s vital that more biosimilars enter the market for the long-term sustainability of healthcare systems.

Supply: Securing Supply Through Resilient Manufacturing

“There's got to be a good integrated supply chain. And if you've got [a reference product], you want the biosimilar to give you redundancy.”

Biosimilars help to create supply surety by increasing the likelihood of redundancy (or excess supply) for treatments. The more biosimilars we have, the more redundancy we can secure.

Recent US policies are incentivizing companies to onshore their manufacturing facilities, advancing the ongoing trend of deglobalization. However, it is not feasible to have a facility in every separate jurisdiction supplying that market. It is expensive to build a biopharmaceutical facility, and it can take years to build one. Crucially, any facility manufacturing biologic medicines must meet strict standards of quality.

An integrated, global supply chain built through trusted partnerships is the most sensible approach.

The Biosimilar Void Needs Urgent Action

“For biologics, most of the markets aren’t saturated. You need, if you’re going to be a small margin, more people being treated.”

Change is happening slowly.

Progress in the regulatory space has been positive, especially with the FDA’s regulatory updates to further streamline biosimilar development. Discussions around the ICH (International Council for Harmonisation) guideline have been encouraging.

All stakeholders should proactively support the development of biosimilars for biologics losing exclusivity in the coming decade.

As we’ve highlighted before in our video on the importance of closing the biosimilar void, accelerating the process of closing the biosimilar void benefits everyone: patients, payers, healthcare providers, and investors.

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