April 20, 2024

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

Samsung Bioepis has brought forward its interchangeability study of Hadlima to speed up its processes for obtaining interchangeability designation in the US market, according to industry sources on 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 a high-concentration, citrate-free formulation of Hadlima by September.

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

Samsung Bioepis and its US partner Organon will launch Hadlima in the US market by July without an interchangeable designation first.

Upon completion of its interchangeability study of Hadlima, the company will seek additional approval from the US Food and Drug Administration to sell the biosimilar with an interchangeable designation. This will allow the company to sell the biosimilar product without additional approval from the prescribing physician.

Industry sources expect the designation to 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 related patents, which prevented Humira biosimilars from entering the market.

A handful of pharma giants -- including Amgen, Boehringer Ingelheim, Pfizer, Samsung Bioepis, Mylan and Sandoz -- reached settlements regarding Humira in the US and plan to launch their Humira biosimilars there in 2023.

There were already eight Humira biosimilars approved by the FDA as of August, of which Amgen’s Amjevita will be the first to launch later this month.

Samsung Bioepis’ high-concentration formulation of Hadlima received approval from the 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, along with its COVID-19 vaccines, was the world’s bestselling drug with global sales of $20.7 billion and $17.3 billion in domestic sales in the US market.

By Shim Woo-hyun (ws@heraldcorp.com)