Several generics of Ofev (nintedanib), Boehringer Ingelheim Korea’s treatment for idiopathic pulmonary fibrosis (IPF), have applied for reimbursement, raising interest over what price ceiling will be set. Although orphan drugs are eligible for the same maximum price as the original product, companies appear to be favoring more competitive pricing strategies.

As of June 1, the Ministry of Food and Drug Safety has approved the following generics: Nintebro (Yungjin Pharm), Ofevia (Daewoong Pharmaceutical), Cuninta (Il-Dong Pharmaceutical), Ofenib (Whan In Pharmaceutical), and Effidanib (Kolon Pharmaceutical). Most are produced in-house, with the exception of Effidanib, which is manufactured by Whan In on Kolon’s behalf.

Yungjin, Il-Dong, and Kolon have reportedly begun reimbursement procedures.

Under current Drug Price Listing and Adjustment Guidelines, an orphan or withdrawal-prevention drug with an equivalent already on the reimbursement list may be granted the same ceiling price. Ofev, designated as an orphan drug, currently receives reimbursement at $15.31 for 100 mg and $19.16 for 150 mg, effective as of May 1. Generics could be listed for reimbursement as early as July.

However, industry insiders expect that generics will not match Ofev’s price. Despite being approved for the same two reimbursed indications—systemic sclerosis-associated interstitial lung disease (SSc-ILD) and chronic fibrosing ILDs with a progressive phenotype (excluding IPF)—the generics are expected to be priced lower, given their lack of IPF coverage and manufacturers' stated cost-driven strategies.

One industry source noted, “Even before Ofev secured reimbursement, generic manufacturers made clear their intent to compete on price. If the first-listed generic adopts a lower ceiling price, it will likely set a benchmark that others must follow. In this case, the orphan drug’s price-matching advantage becomes irrelevant.”