Generic Version of IPF Therapy Esbriet Now Available in US

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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generic version of Esbriet | Pulmonary Fibrosis News | Illustration of pills

Sandoz has launched a generic version of Esbriet (pirfenidone) for people with idiopathic pulmonary fibrosis (IPF) in the U.S.

The new generic is available now via specialty pharmacies and there is a $0 co-pay program for eligible patients, according to Sandoz.

“Sandoz is putting patients first by expanding access to generic pirfenidone for those living with this rare disease, who will benefit from a more affordable, yet equally effective treatment,” Keren Haruvi, president of Sandoz, said in a press release.

Esbriet is an oral medication marketed by Genentech, a subsidiary of Roche, that’s been approved to treat IPF in the U.S. since 2014. It slows scar tissue (fibrosis) development in the lungs in part by blocking the activity of TGF beta, a powerful pro-fibrotic signaling molecule.

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Esbriet approvals were supported by data from three Phase 3 trials that compared the medication against a placebo — ASCEND (NCT01366209), CAPACITY-004 (NCT00287716), and CAPACITY-006 (NCT00287729) — which collectively enrolled more than 1,000 people with IPF.

Results from these studies indicated that treatment with Esbriet significantly slowed the decline in forced vital capacity, a lung function parameter that measures the total amount of air a person is able to exhale after a deep breath. Trial data also indicated Esbriet reduced the risk of death by nearly 50%.

The generic contains the same active ingredient as Esbriet, called pirfenidone. Generics are chemically identical to brand-name medicines, but are sold by other companies. Since they add competition to the pharmaceutical marketplace, generic medicines generally help drive down prices.

According to Sandoz, which specializes in producing generic medicines, few companies have demonstrated capabilities for making generic medications in respiratory and specialty medicine.

“We developed this medicine in-house and continue to build our expertise and infrastructure to support our long-term commitment to grow our respiratory portfolio,” Haruvi said.

Esbriet and the new generic are both approved at a dosage of 801 mg three times a day. It’s recommended that the medicine be taken with food to reduce the risk of side effects such as nausea and dizziness.

Other common side effects associated with treatment include diarrhea, vomiting, loss of appetite, indigestion, abdominal pain, and headache. Others are fatigue, upper respiratory tract infection, stuffy nose, joint pain, weight loss, trouble sleeping, and gastro-esophageal reflux disease.