The US Supreme Court reached a ruling last week that will allow biosimilar companies to launch new biosimilar drugs more quickly. The decision was unanimous that these companies will not need to provide the reference product sponsor with six months’ notice after US Food and Drug Administration (FDA) approval of their intention to launch a generic version of that biological drug.
The case was brought to the Supreme Court over the biosimilar drug Zarxio, when the reference product sponsor and competing biosimilar developer disagreed over how language in the Biologics Price Competition & Innovation Act should be interpreted. That law, passed by Congress in 2009, created a regulatory pathway for FDA approval of biosimilars, and states that 180-day notice from the biosimilar developer must be given to the original product developer, stating intent to launch. This process, coined the “patent dance”, is well-known in the realm of biosimilar development, and is used to determine the patent situation of a biologic and proposed biosimilar before the biosimilar comes to market. The discrepancy was in whether that notice must be given before or after the biosimilar is licensed by FDA.
The Supreme Court ultimately determined that the biosimilar applicant may provide notice before obtaining FDA license, stating that “the statute’s use of the word ‘licensed’ merely reflects the fact that, on the date of the first commercial marketing, the product must be licensed.” Therefore, the biosimilar developer can decide if they want to provide notice before or after receiving FDA approval.
The Biosimilars Council reports that by 2020, brand biologic medicines worth an estimated $81 billion in global annual sales will lose their patents. The mass patent expiration provides a significant opportunity for the development of lower cost biosimilar alternatives, and this Supreme Court decision will only serve to further enhance opportunity for biosimilar developers to get life-enhancing treatments into the hands of more patients, faster.
With such a significant opportunity in the market, the key will be moving new biosimilar candidates through the development process quickly, while still producing reliable and accurate data. BioAgilytix is committed to supporting this area of innovation by bringing together the best scientists, technologies, and processes needed to develop high-quality biosimilars that will ultimately make it to market and provide life-changing treatments to patients at a more affordable price.
If you are interested in finding out more about how BioAgilytix can support your biosimilar development efforts, speak to one of our scientists today.