Samsung Bioepis biosimilar receives U.S. nod

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Samsung Bioepis biosimilar receives U.S. nod

Hadlima, a biosimilar from Samsung Bioepis, was approved for sale in the United States by the Food and Drug Administration (FDA), the company announced Wednesday.

This is the company’s fourth biosimilar approved for marketing in the United States. The lineup now consists of one cancer treatment and three TNF inhibitors, which help stop inflammation. Hadlima is a TNF inhibitor that treats a wide variety of diseases, including arthritis and adult Crohn’s disease. Its reference is Abbvie’s Humira, or adalimumab.

Biosimilars, according to the 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 effectiveness from the reference product, but they cost less.

Hadlima’s FDA approval came after a successful 52-week, phase 3 study involving 544 patients with moderate to severe rheumatoid arthritis.

“With the approval of Hadlima, we are proud to have three anti-TNF biosimilars approved in the U.S. We believe the U.S. healthcare system can benefit from biosimilars, which could play a critical role in broadening access to treatment options for patients with autoimmune conditions across the country,” said Kim Hee-kyung, Samsung Bioepis’ senior vice president and head of regulatory affairs in a statement.

Kenilworth, New Jersey-based Merck will take charge of commercializing Hadlima in the United States. The product is expected to launch in that market after June 30, 2023, under a licensing agreement signed with AbbVie.

In addition to the United States, Hadlima has been approved for marketing in over 30 countries, including 28 European Union (EU) member states, Canada, Australia and Korea.

Domestically, Samsung Bioepis is currently under investigation for accounting irregularities.

Despite this, the company’s products have been doing well overseas. Samsung Bioepis’ European marketing partner Biogen announced Tuesday that the firm’s three biosimilars approved and sold in the market - Benepali, Imraldi and Flixabi, all TNF inhibitors - achieved $184 million in sales in the second quarter.

This was a 6 percent increase from the previous year. In particular Benepali surpassed sales of its reference product in five major European markets. Sales of Imraldi, released last October, grew 33 percent in the second quarter compared to the previous quarter, despite competing with four biosimilars of the same reference in Europe.

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