The idiopathic pulmonary fibrosis (IPF) market is underserved with just two licensed pharmaceutical treatments which are available globally, Roche’s Esbriet/Pirespa (pirfenidone) and Boehringer Ingelheim’s (BI) Ofev (nintedanib), which were both approved by the FDA in 2014. Since the patent expiration of Esbriet in 2021, new generic versions have begun entering the IPF space providing more access to patients, says GlobalData, a leading data and analytics company.

Ramla Salad, Pharma Analyst at GlobalData, comments: “Sandoz launched the first generic of Esbriet in May 2022; the medicine is now available in the US and in the EU in both 267mg and 801mg formulations. This was closely followed by Lupin’s generic, which was launched in August 2023 also in both formulations. The introduction of generic pirfenidone will give more patients access to the medicine which in turn could improve the quality of life of patients living with this rare disease.”

Generic pirfenidone sales are expected to increase year on year as more patients switch to the cheaper versions. Countries such as the UK have already begun switching patients as providing access to complex medicines at a much lower price is at the forefront of care across the country.

Salad concludes: “As with all markets, the introduction of generics impacts the access to and the sales of branded products, but within this market there is already a therapeutic chasm which needs filling, whether that be by a new pipeline agent or by an affordable generic.”