6-Month Notice Ruling Could Raise the Price of Biosimilars

A new court ruling may create another hurdle in the race for launching low-cost, biosimilar-versions of expensive biologicals. A federal appeals court has overturned a previous ruling and decided that biosimilar manufacturers must provide the innovator company a 180-day notice only after receiving FDA-approval for its biosimilar product.

The decision came following an action by the pharmaceutical company Amgen, filed against Apotex, a generic company that is developing a biosimilar to Amgen’s pegfilgrastim (Neulasta), which boosts an individual’s white blood cell count following chemotherapy. The filing falls under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The PBCIA has a step-by-step guide on exchanging information and channeling litigation about related patents, and Amgen has alleged that Apotex’s marketing of their biosimilar to Neulasta—currently under FDA review—would infringe an Amgen patent. And the court has agreed. The court has ruled that the 180-day notice period would begin after Apotex receives the FDA license for marketing its product.

The impact is more near-term, because the delay means the innovator biological, most of which are quite expensive, has additional time on hand before the competition sets in. It also provides them with sufficient time to pursue any patent challenges.

The current appeal came after Sandoz challenged the BPCIA, saying they would share the marketing plans for their biosimilar with Amgen 180 days before FDA approval of the product. The Sandoz case is currently under review with the US Supreme Court according to STAT news.

While health plans and biosimilar manufacturers are already battling the FDA over the naming of biosimilars, the current decision adds another twist to the situation and could significantly impact healthcare costs.

“For biologics on the market for more than 12 years or close to 12 years, this ruling extends the period in which brand-name company has exclusive rights to sell its product,” Elaine Herrmann Blais, a partner at the Goodwin Procter law firm, which represents drug makers that sell biologics and are developing biosimilars, told STAT. “It means another 6 months is tacked on to that period of exclusivity.”

One way out, William Jay, a partner at Goodwin Procter, told STAT, would be if the FDA issues a marketing license for a biosimilar, which would go into effect the day of the marketing approval, so that the countdown to the 180-day period would start the same day that the biosimilar is approved. But that would need the FDA to issue a formal ruling to that order.