Samsung Bioepis Speeding up US Launch of Humira Biosimilar

Samsung Bioepis headquarters in Songdo, Incheon, South Korea (Samsung Bioepis)

Samsung Bioepis has brought forward its interchangeability study of Hadlima to speed up its launch in the US market, according to industry sources, last Sunday.

Hadlima is Samsung Bioepis' biosimilar referencing AbbVie’s blockbuster drug Humira, used to treat rheumatoid arthritis, Crohn's disease, ulcerative colitis and other conditions.

Samsung Bioepis previously planned to complete its study needed to establish the interchangeability of high-concentration, citrate-free formulation of Hadlima by September.

But, the company will now aim to finish the study earlier, in May this year, the sources said.

The goal is to launch Hadlima in the US market by July with an interchangeable designation, which will allow the company to sell the biosimilar product without additional approval from the prescribing physician.

Industry sources expect the designation could help the company secure its share in the adalimumab biosimilar market in the US, in which multiple Humira biosimilars are slated to launch this year.

The main patent for Humira expired in 2016, but Abbvie secured over 200 different surrounding patents, which prevented Humira biosimilars from entering the market.

But, a handful of companies, including Amgen, Boehringer Ingelheim, Pfizer, Samsung Bioepis, Mylan and Sandoz, came to reach settlements regarding Humira in the US and were then able to launch their Humira biosimilars in 2023.

A competitive market is expected as those pharma giants are going to launch their Humira biosimilars soon.

There were already seven Humira biosimilars approved by the US Food and Drug Administration as of August, of which Amgen’s Amjevita will be first launched later this month.

Samsung Bioepis’ high-concentration formulation of Hadlima received approval from the US FDA in August last year. The company’s launch of Hadlima will be processed together with its US partner, Organon.

In 2021, Abbvie’s Humira, alongside the COVID-19 vaccines, was the world’s bestselling drug with global sales of $20.7 billion and $17.3 billion of domestic sales in the US market.

Source: Investor-Shim Woo-hyun

Editor: IPR Daily-Ann