Novartis' Sandoz strikes at Roche with first US generic of blockbuster Esbriet

Despite an ongoing strategic review that might alter Sandoz’s future, the Novartis generics engine keeps churning out new products.

Sandoz has launched the first fully substitutable U.S. generic of Roche’s blockbuster idiopathic pulmonary fibrosis (IPF) therapy Esbriet, the Novartis unit said Thursday.

Sandoz made the move less than two months after a Delaware federal judge nixed a patent infringement lawsuit brought by Roche’s Genentech. In the case, Genentech argued that Sandoz and other drugmakers would violate six Esbriet patents with their proposed generics.

IPF is an immunological disorder involving the respiratory tract. It’s characterized by chronic inflammation of the lung, leading to irreversible scarring of lung tissue. The rare disease affects about 140,000 Americans.

In 2021, Esbriet reeled in 1.04 billion Swiss francs ($1.04 billion) sales. Of the total, 732 million francs came from the U.S., a 4% decline from the prior year.

The drug’s most prominent competitor, Boehringer Ingelheim’s Ofev, generated global sales of 2.49 billion euros ($2.58 billion) last year, a 25% increase at unchanged exchange rates. Ofev has a broader label for other types of interstitial lung disease.

Both Roche and Boehringer are developing next-generation IPF therapies. Roche has recombinant human pentraxin-2, also coded PRM-151 or RG6354, in a phase 3 study. Boehringer is working on BI 1015550, a PDE4B inhibitor, with a phase 3 IPF study planned for this summer.

As for Sandoz, the Novartis subsidiary just strengthened its capabilities in respiratory diseases by acquiring British medical and drug delivery device maker Coalesce Product Development.

Last month, Sandoz launched a generic version of AbbVie’s combo eye drop Combigan to treat elevated eye pressure.

These recent developments come as Novartis has restructured Sandoz to become a relatively autonomous unit and launched a strategic review to decide whether it should spin out the generics business.

The entire U.S. generics industry has been under pricing pressure for years, so Sandoz has shifted its focus to biosimilars and complex generics.

In the first quarter, Sandoz’s U.S. sales declined 2% despite a relatively low prior year comparator. In contrast, its sales in Europe grew 9% at constant currencies.

During an investor call last month, Novartis CEO Vas Narasimhan said the company expects Sandoz’s U.S. oral solids business to hit its lowest level this year and early next year. At that time, the franchise could start to grow on the strengths of biosimilars and new launches, he said.