How many biosimilars are approved in the United States?
The U.S. Supreme Court recently announced that it will review the Amgen v. Sandoz case, a dispute over a Federal Circuit Court interpretation of the Biologics Price Competition and Innovation Act (BPCIA), which was signed into as part of the Affordable Care Act.
One objective of the BCPIA is to expedite the licensing process for biosimilars. However, a provision of the law requires a biosimilar license applicant to provide notice to the maker of the biologic, not later than 180 days after approval by the U.S. Food and Drug Administration, before launching the similar product. The applicant must also provide a copy of the application and information about the product’s manufacturing processes. This series of steps, referred to as the “patent dance,” is intended to resolve potential patent claims before the commercial marketing of the biosimilar.
In February 2016, Sandoz, the biosimilar and generic unit of Novartis, petitioned the Court to hear the case which involves Zarxio (filgrastim-sndz), a biosimilar to Amgen’s biologic Neupogen (filgrastim). Both of these drugs are designed to boost white blood cells in patients being treated for cancer.
Zarxio was approved by the FDA in March 2015, but the Federal Circuit Court ruled that biosimilar makers must wait an additional 6 months after FDA approval before bringing their product to the market. Sandoz argues that it provided Amgen with more than 180 days’ notice of its intent to market Zarxio, and that the FCC ruling adds 180 days of additional exclusivity beyond the period that was expressly provided by Congress in the BCPIA. While Amgen did file a lawsuit to delay the launch, the company did not seek a patent-based injunction.
“The Federal Circuit turned this mere notice provision into a grant of 180 days of additional exclusivity for all biological products beyond the exclusivity period Congress expressly provided—delaying the launch of all future biosimilars by six months,” Sandoz argued.
The Supreme Court’s decision in the patent dance case will have a significant impact on the U.S. biosimilar industry, and the rate at which new products will be introduced to the market. At this juncture it is unclear if makers of biologics will retain the additional 6-month period of exclusivity that was granted by the FCC.
Nonetheless, more biosimilars will inevitably be introduced into the market which means there will be new investment opportunities. Regardless of how the Court rules, pharmaceutical companies must continue to protect the proprietary information of their chemical formulas and manufacturing processes. For this reason, it is essential to engage the services of a leading intellectual property law firm.