Crowding In
On July 1 (local time), the U.S. Humira biosimilar market, worth 24 trillion won a year, opened. In the first week alone, six Korean and foreign companies plan to launch their products.
According to sources in the biotech industry on July 2, Samsung Bioepis launched Hadlima, a Humira biosimilar, in the United States on July 1 (local time). Humira is an autoimmune disease treatment developed by AbbVie and is the world’s top-selling biopharmaceutical product. With sales of US$21.237 billion (27.41 trillion won) in 2022, the majority of its sales have been generated in the United States (88 percent in 2022). With the expiration of the drug’s U.S. patent, the U.S. market for Humira biosimilars opened on July 1. In Europe, the market for Humira biosimilars began in 2018.
In addition to Samsung Bioepis, five other companies launched Humira biosimilars the same day. The five included Bellinger Ingelheim, Pfizer, Coherus and Fresenius Kabi (Idasio). Celltrion and Viatris also announced that they will launch their own Humira biosimilars in early July and on July 31, respectively. Accordingly, a total of seven Humira biosimilars will be launched in July alone. The U.S. Humira biosimilar market is expected to see a total of nine Humira biosimilars that will come out this year. They are expected to have fierce competition to secure bigger pieces of this huge market.
It will be interesting to see how two Korean companies, Samsung Bioepis and Celltrion, fare in this market. They were recently excluded from a list of Humira biosimilars of Optum Rx, one of the top three U.S. pharmacy benefit managers (PBMs), raising concerns that they will fall behind in the competition. The U.S. is a predominantly private health insurance-oriented market and being on a PBM list determines a drug’s key competitive advantage. Currently, the U.S. PBM market for Humira is dominated by three large PBMs, CVS Caremark (33 percent), Express Scripts (24 percent), and Optum Rx (22 percent), which together account for approximately 80 percent of the market, so inclusion on their drug lists could significantly push up a drug’s market share.
Nevertheless, Korean companies say market concerns are overblown. This is because Optum Rx has the smallest market share among the three PBMs, and they are very confident in the competitiveness of their products. Celltrion Healthcare, the company in charge of product sales at Celltrion, said on its website, “There is a misunderstanding in the market regarding the PBM pricing of Humira biosimilars,” adding, “We aim to cover 40 percent of the total adalimumab market. Based on our product’s differentiation and quality, we are in talks with PBMs in consideration of profitability.”
Celltrion’s product has a high concentration so the product can compete well with others. Humira is available in low (50 mg) and high (100 mg) doses. To enhance the competitiveness of the original drug, AbbVie developed a high-concentration formulation of Humira that improves the usage, doses, and other aspects of the original formulation and received U.S. Food and Drug Administration (FDA) approval in 2015. Since then, the Humira market has been reorganized around high concentration products. Today, more than 80 percent of Humira prescriptions in the United States are high-concentration formulations. Of the nine companies licensed, only three are approved for high concentrations -- Celltrion, Samsung Bioepis, and Sandoz.
Celltrion and Samsung Bioepis also have their own differentiation points as their products are free from citrate, which may cause pain, and are promoting the development of interchangeability, which allows pharmacists to prescribe substitute drugs instead of original drugs at their discretion. Only the two companies have all three of these characteristics.
On top of that, Samsung Bioepis has secured approval for a lower concentration product. This means that the company is able to target all Humira biosimilar markets in the United States. Samsung Bioepis’ Hadlima is easier to use as it has fewer dosing steps compared to its original drug and boasts a large amount of real-world data that Samsung Bioepis has accumulated to reach the number one and two positions in the European market.