More U.S. insurers add Samsung Bioepis' Humira biosimilar to formulary listings

More U.S. insurers have included Samsung Bioepis’ Humira biosimilar Hadlima in their formulary listings, which could further boost sales in the $20 billion market.

Samsung Bioepis' Hadlima, its Humira biosimilar [SAMSUNG BIOEPIS]

More U.S. insurers have included Samsung Bioepis’ Humira biosimilar Hadlima in their formulary listings, which could further boost sales in the $20 billion market.

UnitedHealthcare and Centene included Hadlima in their formularies, according to Organon’s earnings report last week. Organon is Samsung Bioepis’ New Jersey-based commercial partner that handles local sales of Hadlima in the United States, Canada and Australia.

The announcement comes after Cigna Healthcare, a private health insurer, added Hadlima's high- and low-concentration formulations in its formulary listing in July.

Prime Therapeutics, one of the five biggest pharmacy benefit managers (PBMs) in the United States, also included Hadlima in its formulary recommendations released in July.

PBMs, as third-party companies functioning as intermediaries between insurance providers and pharmaceutical manufacturers, create formularies, or lists of prescription medications covered by health insurance plans, negotiate rebates with manufacturers, process claims and occasionally manage mail-order specialty pharmacies.

A biosimilar product’s inclusion in formulary listings by insurers or PBMs determines its commercial success in the United States.

Hadlima is an identical copy of Illinois-based AbbVie's adalimumab, better known as Humira. Humira is indicated to treat autoimmune diseases, including rheumatoid arthritis and Crohn's disease.

Humira was the world's best-selling drug for a decade until 2020 when it lost its throne to the Pfizer Covid-19 vaccine. It generated global revenue of $21.2 billion last year, with around 87 percent of the revenue coming from the U.S. market.

Pharmaceutical companies including Samsung Bioepis and Celltrion have been scrambling to tap the massive market as Humira’s U.S. monopoly ended early this year.

Samsung Bioepis has recently announced that Hadlima met its primary endpoints in the interchangeability test. When designated as an interchangeable drug by the U.S. Food and Drug Administration, the biosimilar can be substituted for its reference product at the pharmacy.

BY SHIN HA-NEE [shin.hanee@joongang.co.kr]