Samsung Bioepis, Celltrion Healthcare launch Humira biosimilar in US

Samsung Bioepis and Celltrion Healthcare have launched biosimilars of the autoimmune disease treatment Humira (ingredient: adalimumab) in the U.S.

Samsung Bioepis said last Saturday that it launched Hadlima, its Humira biosimilar, in the U.S. through its partner Organon.

Hadlima is available in two formulations -- low concentration (50 mg/ml) and high concentration (100 mg/ml) – and has two units per packaging unit and is licensed as a prefilled pen (PFP) and prefilled syringe (PFS).

Hadlima is available at a wholesale acquisition cost (WAC) of $1,038, which represents an 85 percent discount in comparison to the list price of Humira, to enable expanded access to patients.

The company also plans to launch a patient support program called "HADLIMA For You," which features comprehensive educational resources including a co-pay program and dedicated nurse coaches who will be available to engage with patients throughout their treatment journey.

The company received U.S. marketing authorization for low- and high-concentration Hadlima in 2019 and last year, respectively, and the same products have been available in Europe since October 2018.

"Over the past four years, we have supplied approximately 6.8 million doses of Hadlima in markets outside the U.S. through strict quality control and supply chain management," Samsung Bioepis CEO Ko Han-sung said. "We hope that Hadlima will expand access to treatment for patients suffering from autoimmune diseases in the U.S."

Celltrion Healthcare also said it launched Yuflyma, its Humira biosimilar, in the U.S. market on Monday. Yuflyma is a high-concentration formulation and is available in both auto-injector and PFS.

Celltrion Healthcare said it had set the WAC of Yuflyma at approximately $6,577, which is a 5 percent discount to Humira based on two doses.

Celltrion noted that the actual selling price of Yuflyma will differ from the suggested WAC price as it will need to take into account additional rebates and discount costs.

The company is also launching a patient assistance program for patients and healthcare providers to help with co-payments and products.

"We plan to launch a variety of patient-facing marketing efforts across the U.S. and will leverage the commercial capabilities of our local organizations to drive Yuflym prescribing," said Thomas Nusbickel, the chief commercial officer of Celltrion USA.

Meanwhile, according to a securities analyst, rebates are higher for more expensive products, making more expensive branded products more popular among pharmacy benefit managers (PBM).

"In the U.S., PBM drug formularies can have a significant impact on prescription expansion, as, in the privately insured U.S. drug market, PBM influence over drug prices is critical," said Kim Min-jung, a DS Investment and Securities analyst.

According to Kim, as of 2022, three PBMs (CVS/Caremark, Cigna/Express Scripts, and UnitedHealth/ OptumRx) account for approximately 80 percent of the U.S. market.

Of these, CVS Caremark, a subsidiary of CVS Health, reportedly holds a 33 percent share of the Humira PBM market, followed by Express Scripts at 24 percent and OptumRx at 22 percent.

In this situation, it is virtually impossible to sell to pharmacies without being listed on a PBM list. Therefore, being on multiple PBM lists and being in the right tier can make or break a sale.

"Typically, the rebates paid to PBMs are a percentage of the drug's list price, so the benefit is that the higher the price, the more rebates they can offer to PBMs," Kim said. "Considering big pharma companies such as AbbVie will offer rebates of around $2,000 to $3,000, the drug prices of Organon and Samsung Bioepis will only offer very small rebates compared to companies that use high rebate strategies."

Kim added that while these lower WAC prices may lose some of their rebate competitiveness, they can exert policy pressure on PBMs.

"PBMs now have to explain why they don't cover products that are at least 85 percent less expensive than the original," Kim said.

Humira is an autoimmune disease treatment for rheumatoid arthritis, spondyloarthritis, and psoriasis developed by U.S. multinational pharmaceutical company AbbVie.

Humira inhibits the cytokine tumor necrosis factor (TNF). The U.S. Food and Drug Administration (FDA) first approved Humira to treat rheumatoid arthritis in December 2002. Since then, Humira has sequentially secured indications for nine autoimmune diseases.

Notably, Humira is a mega-blockbuster drug that has held the top sales spot among pharmaceuticals for nine consecutive years since 2012.

As of last year, it generated sales of about 24 trillion won ($18.3 billion) in the U.S. and 27 trillion won globally.