Pfenex Statement on Amgen v. Sandoz

We applaud the decision of the Federal Circuit Court to uphold the Northern District of California court ruling that the patent exchange provisions (“patent dance”) as outlined under the Biologics Price Competition and Innovation Act (BCPIA) is optional; however we are cautious with the approach of the courts to section two of the ruling, which notes the 180 day notification of launch of the biosimilar cannot be before FDA approval of market authorization.

Biosimilars play a critical role in increasing access to much needed, life-impacting treatments, as seen through the tremendous success of these drugs in Europe and Australia. Once allowed to reach full potential in the U.S., these drugs stand to reduce the burden of healthcare costs and increase access for patients with debilitating diseases. In order to be most successful, it is crucial that government policies create a market that fosters healthy competition between product manufacturers. Through this ruling, while the court has provided a welcome clarification of the usage of the patent exchange provision between the biosimilar and the reference product manufacturer, it has allowed reference product producers an additional six months of diminished competition following a biosimilars approval, thus minimizing both the cost savings and patient access which biosimilar products provide.

Pfenex, as a pure play biosimilars producer, is positively positioned to advance biosimilars proliferation throughout the market. Our unique Protein Expression Technology has the potential to create biosimilars with a fingerprint-like identity to a reference product as determined through robust bioanalytics, allowing us to rapidly develop and create high-quality biosimilars products. With eight biosimilars candidates currently in the pipeline, we are excited at the potential market growth of the these life-changing drugs; however, we urge regulators and legislators to consider the impacts of this ruling on payers, patients and the healthcare system as a whole. Pfenex looks forward to continuing to work closely with stakeholders to create a streamlined path forward for these products that increases patient access and creates a robust global marketplace.