Biosimilars at a Turning Point: Market Growth, Regulation, and Access

Biologic medicines have transformed the treatment of many diseases, but access and affordability remain important challenges across healthcare systems. Could biosimilars offer a solution?     In this episode of Balancing the Future, Chai and Micah speak with Andrew Bourgoin, founder of the Bourgoin Insights Group. Andrew has more than 15 years of experience working across the biosimilars field, from market access to business development.      Biosimilars are biological medicines that are highly similar to an approved reference biologic. Unlike medicines produced by mixing chemicals or through other synthetic processes, they are created using living cells. Scientists study the originator medicine to identify the genetic instructions needed to produce it, then insert those instructions into living cells.    When a biosimilar enters the market, it increases competition and, because the originator drug’s patent has expired, ends any monopoly a company may have over that drug. Together, these factors lower costs for physicians, patients and other stakeholders.    In 2026, the U.S. Food and Drug Administration approved it’s 100th biosimilar — a milestone that Andrew believes signals continued growth in the market. Another important development announced across 2025 and 2026 reduced the requirement for third-stage clinical trials from the biosimilar regulatory process. Previously, biosimilars had to undergo these trials to demonstrate that they were highly similar to the originator drug. Now, earlier-stage laboratory testing can provide that evidence.       Andrew points out that the field’s direction is becoming clearer, with biosimilars in development for treatments ranging from food allergies to retinal conditions.     LINKS:  Andrew Bourgain on LinkedIn  Bourgoin Insights Group Website  METTLER TOLEDO Website  METTLER TOLEDO on LinkedIn  Balancing The Future Podcast Website  Micah Schweizer on LinkedIn  Chai Nussbaumer on LinkedIn    EPISODE SOURCES:  Biosimilar Product Information – US. Food and Drug Administration  How does health spending in the U.S. compare to other countries? - Health System Tracker  FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs - US. Food and Drug Administration  ABOUT BALANCING THE FUTURE:    Science and technology play a key role in solving many of the world’s toughest problems. Balancing the Future introduces listeners to the people and innovations addressing these challenges.      We explore wide-ranging creative solutions that are changing our world for the better. You will hear directly from people making an impact in science and technology, such as, how cultivated foods could shake up both our diets and traditional agriculture, the ways AI might help us find a cure for Alzheimer's, and how tiny 3D ‘organoids’ are already changing the way we test new drugs.      Each episode offers hopeful conversations with scientists, leaders and communicators who are making a difference in their fields.       Join us as we decode the mechanisms behind impactful developments and new ways of thinking. Subscribe or follow us to be sure you never miss an episode.    ABOUT METTLER TOLEDO:  Whether ensuring food safety, developing life-saving medicines, or advancing new technologies, precision, efficacy and accuracy matters. Meeting customers’ expectations takes more than effort; it requires the right partner.  METTLER TOLEDO supports with trusted tools, expertise, and knowledge. Together, we help our clients work more efficiently, stay compliant, and drive innovation, building a safer and more sustainable future for everyone.