Novartis (NYSE:NVS) unit Sandoz said today that the FDA has accepted the abbreviated new drug application for its generic version of Advair Diskus.
The fluticasone propionate/salmeterol device is designed to treat asthma in patients ages 4 and older, as well as provide maintenance treatment of airflow obstruction and reduce exacerbations in patients with chronic obstructive pulmonary disease.
“Sandoz scientists and medical experts have developed a high-quality generic option that we believe offers asthma and COPD patients the same safety and efficacy that they expect from Advair Diskus,” Sandoz president Peter Goldschmidt said in prepared remarks.
“We know the treatment of asthma and COPD place a significant cost burden on patients and the healthcare system in the US. We are confident in our application and data, and we look forward to working with the FDA to provide greater access and affordability for this treatment option.”
Earlier this week, the Supreme Court ruled with Sandoz in a case against Amgen (NSDQ:AMGN), deciding that biosimilar makers can give marketing notice prior to FDA approval. The decision means that biosimilar products can launch faster.
During the case’s arguments in April, Amgen’s legal team argued that the notice to market a biosimilar can’t happen until FDA approval because the product’s indications wouldn’t be known until regulatory approval.
Sandoz and other biosimilar developers argued that that would mean an additional 6-month “exclusivity windfall” that Congress did not mean to create with the Biologics Price Competition and Innovation Act.
