Generics expected to improve access for patients with idiopathic pulmonary fibrosis

The idiopathic pulmonary fibrosis (IPF) market is underserved with just two licensed pharmaceutical treatments that are available globally, Roche’s Esbriet/Pirespa (pirfenidone) and Boehringer Ingelheim’s (BI) Ofev (nintedanib), which were both approved by the FDA in 2014. Esbriet, a dual anti-fibrotic and anti-inflammatory agent, was launched in Europe in 2012 and in Japan in 2008. Ofev—a small molecule tyrosine kinase inhibitor—gained approvals in only Europe and Japan, in 2015. Roche’s Esbriet patent expiry in 2021 paved the way for more competition in the IPF space with developers such as Sandoz and Teva piggybacking off the success of Esbriet. 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. More recently, Lupin, which is an innovation-led transnational pharmaceutical company, announced in late August 2023 that the FDA approved its generic pirfenidone tablets in both 267mg and 801mg presentations (Lupin, press release, 25 August 2023). 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 UK. Although it is expected that Europe will be implementing generic pirfenidone due to its cost-effectiveness, key opinion leaders (KOLs) interviewed by GlobalData across the US have mentioned that generic pirfenidone is used but there is not a specific preference as to which version to use for the treatment of patients with IPF.

Looking ahead, it is anticipated that more companies will begin entering the space with generic formulations to try and capitalise on Esbriet’s patent expiry. According to GlobalData’s Sales and Forecast database, Esbriet raked in global sales of $752m in 2022. It is also expected that Ofev will follow a similar trend to Esbriet as the former’s EU patent expiry in 2025 looms, but it is expected that if successful BI’s late-stage phosphodiesterase-4 (PDE4) B inhibitor, BI-1015550, could follow in the footsteps of Ofev to offset any upcoming competition, whether that be in the form of new pipeline agents or generic erosion. 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 that needs filling, whether that be by a new pipeline agent or an affordable generic.