Prime Therapeutics to cover Samsung Bioepis' Hadlima

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

Samsung Bioepis' Hadlima, its biosimilar referencing Humira, has been included in Prime Therapeutics's formulary, crossing one of the biggest hurdles to tap an approximately $20-billion market.

Prime Therapeutics, one of the five biggest pharmacy benefit managers (PBMs) in the United States, announced Wednesday it will cover Hadlima on its formulary along with Amgen's Amjevita and Boehringer Ingelheim's Cyltezo.

PBMs, as third-party companies that function 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.

PBMs control more than 70 percent of the U.S. pharmacy claims volume, so a biosimilar product's inclusion in a formulary could determine its success.

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.

AbbVie's Humira [NEWS1]

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 that revenue coming from the U.S. market.

AbbVie held an exclusive grip on the market for two decades, raking in nearly $200 billion from sales of the drug during that period.

The announcement is significant to Samsung Bioepis as its drugs were not included in the formularies of Express Scripts and Optum Rx, the second- and third-largest PBMs in the United States. The largest PBM, CVS Caremark, is yet to announce its list.

Prime Therapeutics is the fifth-largest PBM in the United States with five percent of the market share.

Celltrion’s Yuflyma is not included on any PBMs yet, but the company said it is "currently negotiating with various PBMs."

Biosimilars, according to the U.S. Food and Drug Administration (FDA), are biological products that are approved based on proof that they are highly similar to other FDA-approved products. The drugs have no clinically meaningful differences in terms of safety or efficacy from the reference product, but they cost less.

BY SARAH CHEA [chea.sarah@joongang.co.kr]