Jonathan Kay, MD, and Kimberly C. Chen DO, MSHLM, define what a biosimilar is and discuss the potential for a lower cost than the reference product.
Ryan Haumschild, PharmD, MS, MBA: Speaking of biosimilars, one of the things we haven't defined for our viewing audience is what a biosimilar is. Dr Kay, maybe you can speak to what is the biosimilar and maybe discuss the potential impacts of a lower cost compared to the reference product.
Jonathan Kay, MD: Certainly, a biosimilar is a copy of a biopharmaceutical, which no longer is limited by patent. And that copy is an exact copy of the amino acid sequence but because these are produced in living cells, it can't be a completely exact copy. So there's slight variation in terms of post-translational modifications such as constellation, however, the definition in the biologics price competition and Innovation Act of 2009 is the biosimilar is highly similar to the reference product without clinically meaningful differences. It's expected to have similar quality, purity, and potency to the reference product and in practical terms, is studied in terms of analytical comparisons with the reference product, then shown to be highly similar without clinically meaningful differences. There's then a pharmacokinetic study that shows equivalent pharmacokinetic parameters, and at least 1 clinical trial and a disease for which the reference product is approved to show equivalent efficacy throughout the development process immunogenicity is assessed and the biosimilar is shown to be no more immunogenic than the reference product and also comparable in terms of safety. So essentially, a biosimilar is a copy of a biopharmaceutical, it's not a generic because generics are small molecules, where the active ingredient can be reproduced exactly. But the biosimilar, being a complex protein, is not an exact copy. But is shown in an extensive development process to be equivalent in its efficacy, and comparable in its safety to the reference product.
Ryan Haumschild, PharmD, MS, MBA: Excellent overview. Thank you for going through that with us. So now that we've defined biosimilars maybe Dr Chen, what is the potential for these biosimilars to lower costs compared to this reference product?
Kimberly C. Chen DO, MSHLM: Now there is definitely a lot of opportunity in just talking about the development. On average, new medication will take minimally greater than 10 years and the development costs over $2.6 billion. But biosimilars actually take approximately 5 to 9 years and are only about $100 million. So you can even see the cost comparison on developing the drug itself. In 2020, the research actually showed that biosimilars have saved nearly a billion dollars and in 2022 they have actually projected a savings of over $30 billion. And if we continue the use of biosimilars, there's a potential savings of $183 billion in the next 5 years.
Ryan Haumschild, PharmD, MS, MBA: It sounds like there's a great opportunity for biosimilars leveraging almost like our partners have in Europe to really decrease the cost of care and still provide high value.
Transcript edited for clarity.
This activity is supported by an educational grant from Boehringer Ingelheim.