"Major PBM Contract Secured" Celltrion Accelerates 'Zimpendra' US Market Entry Race

Celltrion's new autoimmune disease treatment drug, Zimpenetra (the U.S. launch name of Remsima SC), is accelerating its entry into the U.S. market.

On the 8th, Celltrion announced, "We have achieved a contract to list Zimpenetra with one of the three major Pharmacy Benefit Managers (PBMs) that hold enormous influence in the U.S. insurance market just two weeks after its launch." However, they added, "Due to contract terms, it is difficult to specify the particular PBM at this time."

PBMs are considered the first gateway to the U.S. market. PBMs negotiate drug prices and rebate levels with pharmaceutical companies on behalf of public and private insurers in the U.S., and manage the 'formulary,' which is the list of drugs that can actually be prescribed. If a drug is not included in a PBM's formulary, selling it in the U.S. is virtually impossible.

Zimpenetra has already succeeded in being listed on formularies of various small to mid-sized PBMs, including Blue Cross Blue Shield (BCBS) Minnesota, from the time of its launch. Notably, despite the usual intense negotiations after launch, these PBMs recognized Zimpenetra's innovation and listed it without separate negotiations.

Since the launch, Celltrion has focused on negotiations with the so-called "Big Three PBMs"?CVS Caremark, Express Scripts, and OptumRx?which collectively dominate about 80% of the U.S. PBM market. At the regular shareholders' meeting held on the 26th of last month, Kim Hyung-gi, Celltrion's Vice Chairman in charge of sales, stated, "We are close to signing a contract with one of them," and added, "We aim to have Zimpenetra listed on all three major PBMs within this year to create an environment where prescription reimbursements can be made."

Including this recent contract, Zimpenetra now covers approximately 40% of patients based on enrollment numbers in the entire U.S. private insurance market. Particularly in the western U.S., Zimpenetra has been immediately listed on some insurers' formularies related to this contract, and prescriptions have already begun.

Celltrion is also implementing various patient support programs to accelerate Zimpenetra prescriptions. For patients enrolled in PBMs where the drug is not yet listed, a "Start Program" is in operation. When a contract is imminent, the product is temporarily provided free of charge until it is officially listed. The company explained, "Patient registrations are already underway," and "We continue to receive numerous registration inquiries." Additionally, for some patients who meet contract conditions, even out-of-pocket expenses are being supported.

This major PBM contract is regarded as the first significant achievement in Zimpenetra's U.S. market entry, personally led by Celltrion Chairman Seo Jung-jin. Chairman Seo previously stated about Zimpenetra, "It can generate annual sales of up to 3 trillion won within three years," and "Even conservatively, it could reach up to 5 trillion won."

Chairman Seo has been residing in the U.S. and conducting direct sales activities since before the launch. For this reason, he unusually attended last month's shareholders' meeting via video conference. Regarding his current status, he said, "There are 2,800 hospitals using Zimpenetra in the U.S., and I have visited all of them to introduce the product and increase sales," adding, "I tour hospitals every two weeks and am working to maximize initial launch sales of Zimpenetra by the end of June."

Chairman Seo plans to continue staying in the U.S. for the time being to meet directly with key stakeholders such as local medical professionals. Based on this, he intends to quickly push forward contracts not only with the remaining two major PBMs but also with small and mid-sized PBMs.

This content was produced with the assistance of AI translation services.