BeiGene has officially launched its PD-1 cancer drug Tevimbra in the U.S. more than six months after receiving a much-delayed FDA approval.
BeiGene is pricing Tevimbra at a 10% discount to other PD-1 therapies available in second-line esophageal squamous cell carcinoma (ESCC), for which Tevimbra is currently approved, the company’s newly minted North America general manager, Matt Shaulis, said in a release Friday.
The average wholesale acquisition cost of Tevimbra is estimated to be $15,075 per month, a BeiGene spokesperson told Fierce Pharma. Merck & Co.’s Keytruda and Bristol Myers Squibb’s Opdivo are also approved for second-line esophageal cancer.
Both Keytruda and Tevimbra can be given at 200 mg via intravenous infusion once every three weeks. Keytruda’s current list price is about $11,564 per dose. That means an annual cost of about $196,600 or $208,150 depending on whether 17 or 18 doses were used, respectively.
Tevimbra’s list price was slightly higher than Coherus Biosciences’ Loqtorzi, which was in-licensed from China’s Junshi Biosciences and officially launched in the U.S. in nasopharyngeal carcinoma at the beginning of 2024 at a 20% discount to Keytruda.
Loqtorzi and Tevimbra got their first approvals in China in 2018 and 2019, respectively. After pricing negotiations with the government, Tevimbra’s reimbursed price in China has reportedly been lowered to about 43,500 Chinese yuan ($6,170) per year and Loqtorzi to 32,700 yuan ($4,640) annually.
Seemingly trying to maintain some balance in their global pricing strategies, Big Pharma companies such as Merck and BMS have avoided the drastic PD-1 drug price reductions in China’s national reimbursement scheme, although discounts and financial assistance have been offered to patients.
The low Chinese prices of China-originated PD-1 drugs once raised hopes that they could disrupt the U.S. market, where all PD-1 inhibitors, which are cornerstone treatments for many cancer types, are priced similarly.
The next China-made PD-1 that could reach the U.S. market is Jiangsu Hengrui Pharma’s camrelizumab. Hengrui and its U.S. partner Elevar Therapeutics have a few days ago resubmitted their applications to the FDA for using camrelizumab in combination with rivoceranib in first-line liver cancer. The FDA had in May rejected the partners’ original filings because of deficiencies at a Hengrui plant for camrelizumab.
BeiGene is launching Tevimbra in the U.S. as the company has recently opened the doors to its new biologics facility in Hopewell, New Jersey. The facility features about 400,000 square feet of commercial-stage production space, capacity for about 2 million vials per year and 125 employees. BeiGene hopes the site will get the FDA’s blessing to make commercial Tevimbra as soon as possible.
In addition to second-line ESCC, BeiGene has an ongoing application for Tevimbra in the first-line setting. The company announced in August that the FDA has pushed back its decision due to a delay in scheduling clinical site inspections.
“BeiGene is working closely with the FDA and our investigators to coordinate site inspections,” the BeiGene spokesperson said, adding that the agency has not provided a new target decision date.
During a meeting last week, experts on the FDA’s Oncologic Drugs Advisory Committee voted in support of the agency’s plan to limit PD-1 inhibitors’ uses in first-line gastric cancer and esophageal cancer by excluding PD-L1-negative tumors.