The cost of developing a biosimilar product can range from anywhere between $100 and $200 million. Meanwhile, the cost of treating a patient with a branded product can cost anywhere between $50,000 and $100,000 per year. It’s not difficult to see why biosimilar manufacturers are so passionate about breaking the brand monopoly. According to a recent analysis from the RAND Corporation, introducing biosimilar versions of complex biologic drugs could cut health care spending in the United States by $54 billion over the next decade.
To enable the biosimilar industry to breakthrough and improve patient access to more affordable prescription drugs, a clear regulatory pathway is needed.
When it comes to small molecules, the market dynamics are very predictable. Usually after the launch of generics, the market share of the brand goes from 100% to less than 5% in a matter of a few months. We are seeing pharmacies and hospitals dispensing generics over brands. So, why is it different for biosimilars?
Ultimately, it’s because biosimilars are made from living cells and it is not possible to make an exact copy of the branded medicine, therefore they are not automatically substituted for the existing branded drug the way a generic drug would be. Now new interchangeability guidelines are out in the US, that might change the market dynamics going forward.
Biotech brands drugs themselves, vary from batch to batch. The key, then, is to develop a biosimilar product which falls within the specs of the variability of the brand. If two products behave in the same way, there’s no reason there can’t be interchangeability at both retail and hospital level.
Developing a biosimilar, which has an element of the reference product and has variability that is the same or less than the original, begins with the right clone selection. Then substance analytical capability is required to understand the brand variation and make sure that the variability of the biosimilars falls within the range of the reference product. Essentially, this means that the two products behave in the same manner. An interchangeability study, involving a patient using the brand and biosimilar, is then conducted to prove that the switch does not result in any adverse impacts.
It is crucial for our industry and for US patients to have access to safe and cost-effective alternatives to branded biologics. If a high-quality biosimilar is produced within the variability of the brand, it can, according to the guidelines of interchangeability in the US, be switched and dispensed in hospitals and retail in the same way that generics are. This will allow biosimilars to take market share away from the branded drugs in the same way we’ve seen with small molecules.
Furthermore, we will likely see the FDA requiring brands to reduce the variability of their own products, thus making it easier for biosimilars to reach interchangeability in the future.