Samsung Bioepis’s Humira biosimilar has secured entry into the U.S. market.

Pharmaceutical companies are eyeing the U.S. market as it takes up 70 percent of the overall Humira sales worldwide. A fierce competition is expected in America four years from now.

The U.S. Food and Drug Administration Tuesday approved the sales of Hadlima, Samsung Bioepis’s biosimilar to Humira. Humira is AbbVie’s blockbuster rheumatoid arthritis treatment which dominates the global market by recording around 23 trillion won ($19.5 billion) of global sales last year. The U.S. market is the biggest, which rings up about 16 trillion won in sales.

Several Humira biosimilars, including those produced by companies such as Amgen, Sandoz and Boehringer Ingelheim, had the FDA approval but none of them have launched sales yet, due to patent fights with AbbVie. All of the drugmakers of the Humira biosimilars agreed with the original maker to launch their products in 2023.

Specific launching dates vary. Amgen is expected to enter the U.S. market first as it can kick off sales in January 2023. Mylan and Beringer Ingelheim can start sales from July 2023, and Sandoz and Fresenius Kabi, from September 2023, respectively. Samsung Bioepis can launch its product after June of that year.

Boehringer Ingelheim issued patent litigation against AbbVie but decided later to settle it. The competition over Humira biosimilars is expected to get intense after four years in the U.S. market, as more companies, including Pfizer, Celltrion and Momenta, are close to developing their products, hoping to enter the market in 2023.

As the launching of rival products will happen at a similar period in part because of patent issues, the companies are making efforts to enhance the competitiveness of their products by differentiating them with the existing biosimilars.

Celltrion is the only company that developed a Humira of a higher-concentration formulation, differentiating its product from other biosimilars, reflecting the recent trend in the Humira market that is going for high-concentration products. If Remsima SC, a biosimilar of Remicade produced as an under-the-skin injection formula, wins approval, the company can enter the Humira market for several indications. Remsima SC is applying for approval as a new medicine, not as a biosimilar, and will have an advantage when it comes to winning listing on the U.S. private insurance.

Given the Humira biosimilar competition in Europe, Samsung Bioepis will likely be quite competitive in the U.S. market, too. Samsung Bioepis’s Imraldi (product name of the company’s Humira biosimilar in the European market) is leading the European market where the drug is competing with Amgen’s Amgevita, Sandoz’s Hyrimoz and Mylan’s Hulio.

Imraldi takes up 46 percent share in the European Humira biosimilar market, the biggest among its competitors, according to global health research firm IQVIA. Its sales have been high flying as well. According to a recent earnings report of the drug’s European partner Biogen, the second-quarter sales of Imraldi was $47.3 million (56.7 billion won). Its sales in the final quarter of 2019 and the first quarter of 2019 were $16.7 million and $35.7 million, respectively.

Samsung Bioepis has extended shelf life of Imraldi from 14 days to 28 days in Europe, increasing patient convenience. The label change, however, is not applied to the U.S. market.

AbbVie appears set to begin preparations to guard its market share from 2023. It lowered its product’s price to an unprecedented level in Europe, down to even 80 percent in some countries. The company seems to have decided to guard its market share despite lower profit. Abbviee is likely to take defensive moves actively in the U.S. market from 2023 as well, including price cuts and rebates.

One positive aspect is that the FDA is announcing remedial steps to expand the market for biosimilars. The U.S. agency has recently issued the final version of a guideline on the interchangeability of originals and biosimilars through cross-prescribing them. As the guideline clarifies the conditions on which biosimilars can be interchanged, rivaling drugmakers are likely to step up efforts to acquire such qualifications.