A unanimous decision in Sandoz Inc. V. Amgen Inc. decided that the 180-day notice of commercial marketing required by the BPCIA can be sent before a biosimilar is licensed, reversing a fractured Federal Circuit panel that had ruled that the notice had to be sent after the FDA approved a biosimilar. The decision is likely to speed up the U.S. launch of biosimilars after it resolved questions about the Biologics Price Competition and Innovation Act (BPCIA) – but raised a few more uncertainties in the process.

In challenging the Federal Circuit ruling, Sandoz Inc. claimed that it gave an innovator six additional months of exclusivity. (See BioWorld Today, July 22, 2015.)

The two biosimilars that have launched in the U.S. – Sandoz’s Zarxio, referencing Amgen’s Neupogen (filgrastim), and Pfizer Inc.’s Inflectra, referencing Janssen Biotech Inc.’s Remicade (infliximab) – waited the additional six months after being licensed, but going forward, a biosimilar conceivably could be launched as soon as it gets the FDA green light.

Samsung Bioepis didn’t respond to a request for comment on whether the decision would change its launch plans for Renflexis, a Remicade biosimilar approved in April, but both Sandoz and Pfizer welcomed the news. “The justices’ unanimous ruling on the notice of commercial marketing will help expedite patient access to life-enhancing treatments,” said Carol Lynch, global head of biopharmaceuticals at Sandoz. (See BioWorld Today, April 25, 2017.)

Pfizer spokeswoman Allyanna Anglim said, “The court’s decision reinforces the important role of biosimilars in the U.S. and benefits biosimilar manufacturers by helping to facilitate a more timely delivery . . . following FDA approval.”

With several of its biologics facing biosimilar competition, Amgen wasn’t so pleased – even though its own biosimilar pipeline could benefit from the decision. “While we are disappointed in the court’s decision on the notice of commercial marketing, we will continue to seek to enforce our intellectual property against those parties that infringe upon our rights,” Amgen spokeswoman Kelley Davenport said.

King & Spalding partner Dr. Margaret Bolce Brivanlouis gave us his opinion on the impact of the ruling on the pharma market, which he calls a “welcome first step”.

“This case is the first word from the SCOTUS on the Biologics Price Competition and Innovation Act (BPCIA) and a welcome first step in clarifying certain provisions, deciding that injunctive relief is not available under federal law to force a biosimilar applicant to provide its application and manufacturing information and engage in the statutory dispute resolution mechanism, although they leave open that relief may be available under state law.  The relatively new statute is complex and many aspects of it open to interpretation and recent litigation.  What’s at stake is how soon a biosimilar can come on the market after FDA approval.”

“In addition, SCOTUS reversed the CAFC in holding that a company seeking to market a biosimilar can provide the statutorily required 180-day notice of commercial marketing at any time, and need not wait for FDA approval to do so.  The CAFC’s position had, for those biologics where the 12 year from approval regulatory exclusivity period had already run, given the innovator essentially an additional 180 days of exclusivity after the FDA had approved the biosimilar for marketing.  For both innovators and biosimilar applicants, increased certainty should be welcome.”

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