For the last two months, biologics companies have been closely watching the case of Amgen v. Sandoz. This case represents a critical turning point in the U.S. biosimilars development landscape. It is no surprise, then, that Tuesday’s decision by the Federal Circuit Court in this landmark case was met with a strong response from the industry. In its ruling, the Court held that:
- The patent exchange provisions (“patent dance”) as outlined under the Biologics Price Competition and Innovation Act (BCPIA) is optional for companies submitting a biosimilars application to the FDA.
- The 180-day notification of launch of the biosimilar cannot be before FDA approval of market authorization.
Why is this case so important to biologics and biosimilars producers? Most importantly, Amgen v. Sandoz provides important clarity for both biosimilar and originator companies regarding the BPCIA approval pathway and allows an expeditious avenue for resolving patent disputes. To examine this more closely, let’s take a look at each part of the decision and what it means for the future of biosimilars in the U.S.:
The first part of the decision offered a big win for biosimilars sponsors, allowing them an important choice: whether to devote resources to appeasing the complex, multi-step ‘patent dance’ or opt out of the process. But – while the first part of the ruling was a clear win for biosimilars producers – there are reasons to be wary of part two of the decision. The 180-day notification period means the biosimilar cannot be launched until six months have passed following FDA approval. But, while this directive gives pause, it’s important to note that many biosimilars are likely to be driven through patent expiry rather than data expiry. Biosimilar producers have the opportunity to plan this six month period to coincide with these expirations, which would mean that the biosimilar could potentially hit the market sooner, resulting in potentially less impact on patients.
Pfenex is primed to bring biosimilar therapies to the market. Our unique expression platform allows us to develop molecules efficiently and accurately. Because of this, we can rapidly develop proteins and products- meaning that even with the delay period, we will bring less-expensive drug alternatives to patients in a timely manner. You can learn more about the Pfenex Protein Production Platform and how this unique technology drives our pipeline here.
Overall, we are pleased with the decision and believe that as regulation and litigation continue to clarify the BPCIA, the system will become more standardized. Biosimilars producers and reference product manufacturers will be able to work through the development and approval process more smoothly–ultimately allowing even more patients access to these life-changing medications.
For more, read our full statement on the ruling.