On June 12, 2017, the U.S. Supreme Court unanimously ruled that biosimilar applicants will no longer be required to wait for an additional 180 days to launch their biosimilar product once the U.S. Food and Drug Administration (FDA) has granted regulatory approval. Furthermore, the decision is likely to provide biosimilar applicants the option of not participating in the patent notification procedure, the disclosure of data relating to a biosimilar’s biologic license application and manufacturing process outlined in the Biologics Price Competition and Innovation Act (BCPIA).
The 9-0 decision in favor of generic drugmaker Sandoz in a dispute with biotech giant Amgen means that biosimilars, lower-cost, near-copies of pricy biologic medicines, will be able to reach the market sooner. The dispute involves Zarxio, an drug that Novartis’s Sandoz developed that competes with Amgen’s Neupogen, The case arose after the two companies disagreed over how to interpret language in the Biologics Price Competition & Innovation Act. Congress passed that law in 2010 to create a regulatory pathway for FDA approval of biosimilars. A key issue in the dispute was whether a requirement for a 180-day notice of intent to launch must be given to the developer of the original product before or after the biosimilar is licensed by FDA.
In 2015, a federal appeals court ruled that biosimilar developers must give the 180-day notice after FDA approval. But the Supreme Court disagreed, saying that an applicant may provide notice before obtaining a license. Amgen’s position is that a biosimilar applicant must wait until its product is approved by FDA before providing notice. Sandoz argued that notice may be given before approval.
The court did not address several fundamental issues regarding companies’ rights to patent exclusivity and timing, commenting that those issues would better be decided by the legislative branch or state courts. However, the ruling showcases how changes may be in the offing for the protection granted research pharmaceutical companies and the opportunities available for generic manufacturers.
This decision also affects Pfizer and Celitrion’s biosimilar version of Remicade under the trade name Inflectra and Samsung Bioepis and Merck’s biosimilar version of Remicade under the name Renflexis. Both drugs have received FDA approval and will most likely be commercially available immediately. Partnering with RemedyOne can help pharmaceutical companies optimize their strategies and carve out their best-case market positions with providers, healthplans, PBMs and more.