The U.S. price of the first PD-1 inhibitor developed in China has been revealed.
Coherus BioSciences has established a wholesale acquisition cost for Loqtorzi at $8,892.03 per single-use vial, the company said Monday in a securities filing. The PD-1 inhibitor was licensed from China’s Junshi Biosciences and was approved by the FDA last month to treat advanced nasopharyngeal carcinoma (NPC).
When used alongside chemo as a first-line treatment for patients with metastatic or recurrent locally advanced NPC, Loqtorzi is given at a fixed dose in a vial every three weeks. That means Loqtorzi’s list price is 20% lower than the $11,115.04 triweekly price Merck & Co. currently has for its top-selling PD-1 drug, Keytruda.
The size of Coherus’ price reduction is also smaller than what Eli Lilly had once promised for a China-made PD-1 inhibitor. Last year, Lilly said it would offer its then Innovent Biologics-partnered Tyvyt at a 40% discount compared to existing PD-1s. That kind of pricing never came to fruition after the FDA declined to approve Tyvyt as a non-small cell lung cancer treatment, and Lilly later returned the drug to Innovent.
During a conference call with investors following FDA’s approval, Coherus CEO Denny Lanfear said his company won’t adopt “heavily discounted pricing” for Loqtorzi. Coherus consides 20% a “modest” discount, and Loqtorzi now comes with a “very reasonable” entry-point price, Lanfear said in an interview with Fierce Pharma.
Before Loqtorzi’s FDA approval, there was already some off-label PD-1 use for NPC in the U.S. Coherus came up with the price to make sure “there weren’t any impediments to rapid adoption” to Loqtorzi per FDA label, and the official nod allows Coherus to promote the drug to patients and physicians, the chief executive said.
PD-1 inhibitors are known for their ability to reach multiple cancer types. Coherus doesn’t plan to change Loqtorzi’s price as the drug expands to new indications, or, as Lanfear put it, “our price is not a function of the indication.” But low-percentage-point annual increases according to the industry’s standard practice should be expected, he added.
With Loqtorzi, Coherus sets a new price benchmark for other China-made PD-1 inhibitors to come. BeiGene is currently awaiting a much-delayed FDA decision for tislelizumab as a second-line treatment for esophageal squamous cell carcinoma. Novartis recently ditched a partnership around that drug, citing an evolving treatment landscape.
Elsewhere, Arcus Biosciences is developing zimberelimab, for which the company licensed ex-China rights from WuXi Biologics and China’s Gloria Biosciences. Fosun Pharma is also advancing serplulimab, developed by its subsidiary Shanghai Henlius Biotech. Elevar Therapeutics last month signed a licensing deal that allows the U.S. biotech to use Jiangsu Hengrui Pharma’s PD-1 inhibitor camrelizumab with the VEGFR inhibitor rivoceranib for unresectable liver cancer. The FDA is scheduled to reach a decision on that indication by May 2024.
Drugs developed by Chinese companies are typically cheaper than those by their U.S. competitors. That’s partly because R&D activities in China are less costly than in Western countries. But that gap may be narrowing at least for cancer drugs seeking U.S. approvals.
The FDA rejected Tyvyt because its pivotal trial data came from China alone and the PD-1 drug was measured against an outdated therapy. The U.S. agency made an example of Tyvyt, pushing for global clinical trials that reflect the U.S. treatment landscape. That means those Chinese cancer drugmakers will have to run their trials at a higher cost outside China.