In the past seven months, Boehringer Ingelheim has won approval and label extensions in the U.S. for two of its newest products, Jascayd and Hernexeos.
But back home in Europe, German private companies are still waiting for approval for their treatments.
On Wednesday, Boehringer Chairman Shashank Deshpande expressed dissatisfaction with the regulatory situation in Europe during a 2025 earnings call, noting that it took just 44 business days for the FDA to begin the second approval of lung cancer drug Hernexeos.
“Why is it possible in one jurisdiction or region, but why does it take six months, nine months in Europe? Deshpande asked.
Deshpande, who also heads Boehringer’s Human Pharma division, believes the regulatory environment is holding back innovation in Europe.
“Whether you use any metric, whether it’s clinical trials, drug approvals or biotech deals, there is a clear decline in European competitiveness across the board,” Deshpande said. “It’s clear that China is increasing its innovative power and power. When we look at Europe, we have to look at the facts. They say that we used to be the pharmacy of the world, especially in this country. So as we look at reduced production and increased regulation, we are certainly concerned that Europe is falling further behind.”
According to the company, the launch of both new products in the United States is proceeding smoothly.
Deshpande said, “We’re seeing very high adoption of both brands.”
Juskyd is the first new treatment for idiopathic pulmonary fibrosis (IPF) in more than a decade. IPF is a potentially fatal disease that causes scar tissue to build up in the lungs, limiting oxygen uptake. As a selective phosphodiesterase 4B (PDE4B) inhibitor, Jascayd brings to market a new mechanism of action led by Boehringer’s blockbuster tyrosine kinase inhibitor Ofev, which was approved in 2014.
“The feedback we are getting is that we are addressing an unmet medical need,” Deshpande said. “As far as Juskaid is concerned, we are tracking above and beyond Ofev’s historic launch performance, which is always a good indicator of Juskaid’s performance.”
Ofev, which became BI’s second best-selling product in 2025, generated €3.8 billion ($4.3 billion) in 2025, an increase of 5% after accounting for currency fluctuations.
“The combination of Ofev and Juskaid is also on the rise,” Deshpande added. “That being said, of course, we expect Ofev sales to decline over the next few years as Juskyd enters the market.”
In December, two months after its initial approval, Boehringer decided on an FDA expansion of Juskyd for the treatment of progressive pulmonary fibrosis.
In terms of overall performance, Boehringer reported that sales in 2025 will increase by 7% after adjusting for currency to 27.8 billion euros ($31.4 billion). Human Pharma’s sales also rose 7%, led by diabetes and heart failure drug Jardiance, with sales of 8.8 billion euros ($9.9 billion), up 9% from a year ago.
