HONG KONG – Samsung Bioepis Co. Ltd., a South Korean biosimilar developer, said the FDA approved its July 2018 application for Hadlima (adalimumab-bwwd), a biosimilar referencing Abbvie Inc. blockbuster TNF-blocker Humira (adalimumab).

A treatment for various diseases, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis, Humira hit $19.9 billion of sales worldwide in 2018. Since 2010, its total global sales have reached $115 billion, with the U.S. accounting for 58% of sales.

Samsung Bioepis' license to launch the Humira biosimilar in the U.S., however, won't begin until June 30, 2023.

Hadlima is the fourth Humira biosimilar to clear the FDA, though none have launched. Amjevita, of U.S. firm Amgen Inc., has an anticipated launch of Jan. 1, 2023, under a deal with Abbvie. Hyrimoz, from Sandoz Inc., a unit of Novartis AG, is prepping for a September 2023 launch. And German company Boehringer Ingelheim GmbH has not yet disclosed a launch date for Cyltezo.

"In the U.S. market, Hadlima will be commercialized by Merck & Co. Inc., headquartered in New Jersey, one of the largest global pharmaceutical companies. Marketing details have not been confirmed yet. We are going to internally discuss them based on the licensing contract signed with Abbvie," a spokesman at Samsung Bioepis told BioWorld Asia.

Besides the U.S., Hadlima has been sold in the 28 European Union (EU) member countries since October 2018, under the name of Imraldi. The biosimilar was also approved for sale in Canada, Australia and Korea in the same year.

With the approval of Hadlima, Samsung Bioepis now has four biosimilars approved by the FDA. It has also become the first company to receive FDA approval for biosimilars referencing all three anti-TNF medicines, which also include Renflexis (infliximab-abda, referencing Remicade from Johnson & Johnson Inc.) approved in 2017, and Eticovo (etanercept-ykro, referencing Enbrel from Pfizer Inc. and Amgen Inc.), approved this year. Renflexis was launched shortly after its 2017 approval, in partnership with Merck. No launch date has been announced yet for Eticovo. A biosimilar of etanercept developed by Sandoz has yet to launch, despite winning FDA approval in 2016.

Global sales increase

Founded in 2012, Samsung Bioepis is a joint venture of Korean biopharmaceutical company Samsung Biologics and U.S. biotech Biogen Inc. (See BioWorld, May 6, 2019.)

While Samsung Biologics focuses on its contract manufacturing organization, Samsung Bioepis is responsible for biosimilar R&D. The two companies lead the bio business of Samsung Group, a Korean global conglomerate.

The company's possible next product is a biosimilar referencing oncology treatment Avastin (bevacizumab, Roche Holding AG). The EMA accepted the review of its marketing authorization application in July.

The company is also currently conducting clinical trials of two biosimilar candidates and one novel biologic. The new biologic is an ulinastatin-Fc fusion protein for use in gastroenterology. The biosimilars are referencing Lucentis (ranibizumab, Roche Holding AG) for the treatment of wet age-related macular degeneration, and Soliris (eculizumab, Alexion Pharmaceuticals Inc.), a medicine for paroxysmal nocturnal hemoglobinuria.

The Korean biosimilar developer's global sales have increased from last year. According to the company on July 24, Samsung Bioepis' sales for the first half of this year reached $358.8 million, which is 66% of the sales for the whole of 2018 ($545.1 million). Enbrel biosimilar Benepali was the lead performer, bringing in $120.3 million, while Imraldi and Remicade biosimilar Flixabi brought in, respectively, $47.3 million and $16.8 million. Biogen estimates the three biosimilars are administered to more than 170,000 patients in Europe a year.

Despite its sales growth, the company made a loss of SKW102.8 billion (US$8.7 million) last year. Keunhee Seo, analyst at Samsung Securities Co. Ltd., tentatively expects the biopharmaceutical firm to make a profit this year.

"The company has less burden compared to other competitors thanks to the profit distribution structure: The Korean company's biosimilar products are commercialized by Biogen and Merck. After deducting royalties, manufacturing costs, and marketing expenses from the sales, Samsung Bioepis takes 50 percent of the profit. Based on this system, the Korean company can grow its business stably," Seo told BioWorld Asia.

However, there is uncertainty about the company's prospects due to the ongoing fraud scandal involving its stakeholder, Samsung Biologics. Biologics is accused of having intentionally violated accounting rules by inflating the value of Bioepis ahead of Biologics' IPO in 2016. Along with the accusation, two Bioepis employees were arrested in May. Furthermore, Biologics CEO Taehan Kim, has been accused of embezzling SKW3 billion (US$2.6 million). Prosecutors sought an arrest warrant for Kim, but the court dismissed it on July 22. (See BioWorld, May 6, 2019.)

"The result of investigation into Biologics' scandal might give an impact on Bioepis' business. There is a possibility that it will be a negative effect," Seo noted.