“Imagine that you want to exactly reproduce the best wine you ever tasted.”

Biopharmaceuticals have revolutionised the treatment of serious diseases, allowing healthcare professionals to treat severe illnesses in areas such as ophthalmology, immunology and cancer therapy. However, they are extremely expensive, with biopharmaceutical treatment typically costing up to 15 times more than a purely synthetic drug. As a result, these treatments are partly responsible for the sharp rise in healthcare costs. As the conference day drew to a close, Dr. Stefan Glombitza, CEO of Formycon AG, presented biosimilars, a technology still in its infancy that can help reduce costs by up to 50%. In terms of traditional drugs, biosimilars can best be compared to generics. High costs mean that, even in Germany, only some patients are able to access to biopharmaceutical therapies and have to endure long waits to do so. Thanks to their cost savings, biosimilars make it easier for patients to access highly-effective therapies and help to considerably reduce the financial burden on the healthcare system.

This means they also offer significant potential, according to Glombitza. Sales of biosimilars in Germany totalled EUR 75 million in 2012, a figure that snowballed to more than EUR 2,300 million by 2022. These drugs were prescribed in 70% of suitable cases in just the first year after their approval. In 2022, biosimilars saved around EUR 1.7 billion in costs in Germany. Forecasts suggest that annual savings from using biosimilars could exceed USD 100 billion worldwide in 2026 and 2027. According to Glombitza, “the age of biosimilars has begun”.

He pointed out that the development and manufacture of biosimilars is anything but trivial, as biopharmaceutical drugs are made up of highly complex protein structures up to 1,000 times larger than conventional small molecules. These first have to be analysed and then replicated. Glombitza illustrated this using a comparison from the world of technology: Aspirin is made up of 21 atoms – to use a transport analogy, this is the equivalent of a bicycle, according to the Formycon CEO. A major biological drug, on the other hand, can consist of more than 25,000 atoms – making it less like a bicycle and more like a business jet. And how is the whole thing replicated? At this point, Glombitza made another comparison that left a lasting impression. “Imagine that you want to exactly reproduce the best wine you ever tasted and bring it to market – it would be an extremely complicated process.”