Samsung Bioepis enters US market for biosimilars of Humira

South Korea's biopharmaceutical company Samsung Bioepis, which was expected to struggle on the US market for biosimilars of Humira, the world's top-selling treatment for autoimmune diseases such as rheumatoid arthritis, has received a major boost in this venture.

Prime Therapeutics, the No. 5 PBM in the US, on Wednesday said it included Samsung Bioepis' Hadlima, a Humira biosimilar, on its new formulary recommendations. As early as this month, regular patients in the US could receive insurance coverage of prescriptions for Hadlima.

Earlier, American insurance giant Cigna Healthcare will add Hadlima as prefered alongside HUMIRA on its value, advantage and total savings formularies from September.

Samsung Bioepis, which launched the biosimilar early this month, is thus expected to secure a network covering 10% of the US market per industry estimates. The company, however, is not yet listed in the formularies of major American PBMs.

In American medical insurance, PBMs and insurers, which act as intermediary managers, must each provide a list of drugs and treatments to determine insurance benefits for patients and sell them.

Humira's global sales last year reached $21.2 billion, and this is why world pharmaceutical giants like Pfizer of the US, Boehringer Ingelheim of Germany and Sandoz Pharmaceuticals of Switzerland simultaneously launched biosimilars of the drug after AbbVie's patent on Humira expired late last month.

Samsung Bioepis is expected to boost its share of the US market with its high-concentration products, experience leading Europe like through prescription data and price competitiveness. Both its high- and low-concentration items have received approval from the US Food and Drug Administration.

Another strength is the company's sales of a Humira biosimilar in Europe since 2018. Samsung Bioepis is at the forefront of the market there thanks to high prescription performance that raked in cumulative sales of 1.2 trillion won.

"Over the past four years, strict quality control has resulted in the supply of an estimated 6.8 million units outside of the US," Samsung Bioepis CEO Christopher Han-sung Ko said.

The company sells Hadlima at an 85% discount from Humira under a strategy seen to seek a lead on the US public insurance market, which will eventually be opened.

Write to Dae-Kyu Ahn at powerzanic@hankyung.com