Samsung Bioepis to indirectly sell Soliris biosimilar in US

Samsung Bioepis sells its Soliris biosimilar directly in Europe but decided to indirectly sell the drug in the U.S.

Enters into a strategic partnership with Teva for the commercialization of the rare disease drug Epysqli

Makes a strategic decision considering the cost burden and the specificity of the U.S. market, which is centered on private insurance

Plans to launch Epysqli in the US in the first half of the year... Low price is a strength compared to the original

Samsung Bioepis has signed a partnership agreement with the multinational pharmaceutical company Teva Pharmaceuticals to commercialize biosimilars of rare disease treatments in the United States.

 

Samsung Bioepis will launch the biosimilar through Teva in the U.S.

 

market in the first half of this year.

 

Unlike in Europe, where Samsung Bioepis has been selling its drug directly, the company's strategy in the U.S.

 

has been to forge a partnership to enter the market.

 

Analysts say this is due to the complex structure of the U.S.

 

drug market, which is centered on private insurance, and the cost burden of direct sales.

 

Samsung Bioepis enters into a partnership with Teva to commercialize Epysqli...

 

to launch in the U.S.

 

in the first half of the year

Samsung Bioepis

According to industry sources on the 13th, Samsung Bioepis recently signed a commercialization partnership agreement with Teva to launch Epysqli, a biosimilar version of the rare disease treatment Soliris (eculizumab), in the US market.

 

Soliris was developed by Alexion, a U.S.

 

developer specializing in rare disease therapies.

 

It received marketing authorization from the U.S.

 

Food and Drug Administration (FDA) in March 2007 and the European Commission (EC) in June of the same year.

 

In 2021, AstraZeneca acquired Alexion and took over the rights to Soliris.

 

Soliris is indicated for rare diseases, including paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), neuromyelitis optica syndrome disorder (NMOSD) generalized myasthenia gravis (gMG).

 

In 2023, Soliris reported global sales of USD 3.145 billion (approximately KRW 4 trillion).

 

Of this, the U.S.

 

market is estimated to be worth about KRW 2.3 trillion and the European market is estimated to be worth about KRW 1 trillion.

 

Epysqli is the first hematology biosimilar developed by Samsung Bioepis.

 

Samsung Bioepis obtained the EC marketing authorization for Epysqli for PNH in May 2023 and launched it in the European market in July of the same year.

 

In Korea, it has been on the market since January last year after receiving approval from the Ministry of Food and Drug Safety.

 

In the U.S., the FDA approved Epysqli for PNH and aHUS in July last year.

 

In November last year, the FDA approved an additional indication for its treatment of gMG.

 

Under the agreement, Samsung Bioepis will launch Epysqli in the U.S.

 

market through Teva.

 

The launch is expected in the first half of this year.

 

Samsung Bioepis will be responsible for the production and supply of Epysqli.

 

Teva will be responsible for the drug’s marketing and sales activities in the US.

 

This agreement brings Samsung Bioepis' total number of international partners to four.

 

Samsung Bioepis currently has forged commercialization partnerships with Biogen, Organon, and Sandoz in overseas markets.

 

The partners have exclusive rights to sell the contracted products in the targeted territories and pay Samsung Bioepis milestones and sales commission royalties.

 

Under the new agreement, Samsung Bioepis will receive milestone payments from Teva.

 

Both companies will also share a percentage of product sales revenue.

 

Specific milestone amounts and revenue-sharing percentages for each company were not disclosed.

 

Decided to forge partnership in the U.S., unlike selecting direct sales in Europe, considering the U.S drug structure and costs Epysqli is the only product that contains the company’s name in the product name and is also Samsung Bioepis’ first direct sales product.

 

Epysqli indications, PNH, and aHUS are among those ultra-rare diseases that have a very small number of patients.

 

Samsung Bioepis decided to establish a direct sales system for the first time for Epysqli among all its products, believing that it could fully carry out sales activities with its small number of salespeople.

 

By selling directly without distributing through partners, Samsung Bioepis can reduce commission expenses and increase profitability.

 

Domestic companies pay around 30% to 40% of sales on average as commission to partners when expanding overseas.

 

Another advantage is that it gives the company more market control.

 

In Europe, the effects of the company’s direct sales are slowly showing results.

 

As of the third quarter of last year, Epysqli held the No.

 

1 market share for eculizumab-based biosimilars in Germany and Italy.

 

It has also secured contracts with the largest procurement group in France (UniHA) and the Dutch government.

 

Samsung Bioepis

Nevertheless, Samsung Bioepis' decision not to directly market Epysqli in the U.S.

 

was based on the complex drug structure in the U.S.

 

and the initial direct marketing costs.

 

The European drug market uses a tender system, making it relatively easy to enter.

 

On the other hand, the U.S.

 

drug market has a complex structure centered on private insurance, so it would have been difficult for the company to go direct.

 

The cost of establishing an initial direct sales system may also have been a burden.

 

While the profitability of a direct sales system increases with the number of products sold, it requires large fixed costs to establish a local subsidiary and hire specialized sales and marketing personnel.

 

Will seek to accelerate its entry into the U.S.

 

market with its lower drug price than the original (KRW 400 million/year) and product competitiveness Samsung Bioepis aims to speed up its expansion into the U.S.

 

market by capitalizing on Epysqli’s price competitiveness and product competitiveness.

 

Soliris is an ultra-high-priced drug that costs about KRW 400 million per year.

 

Epysqli’s domestic drug price is set at KRW 2.51 million per vial.

 

This is half the price of the original drug, which costs KRW 5.13 million.

 

This is also about 30% lower than the price of Soliris, which was newly introduced in April last year at KRW 3.6 million.

 

The idea is to gain an advantage over the original through its price competitiveness and expand patient access.

 

Being ‘sorbitol-free' is also considered a competitive advantage of Epysqli.

 

Sorbitol is a substance that helps improve the stability of medicines.

 

However, it can cause reactions in patients with fructose intolerance, who cannot digest fructose precursors such as fructose or sugar.

 

In Europe, medications containing sorbitol are banned for people with fructose intolerance.

 

The U.S.

 

has no such prohibition.

 

However, industry experts believe that given the potential for reactions in some patient populations, it is likely that clinicians will favor products without sorbitol.

 

Epysqli’s competitor, Amgen's Soliris biosimilar Bkemv contains sorbitol.

 

However, the original company’s patent defense strategy may serve as a variable.

 

Alexion is marketing Ultomiris, a once-eight-weekly dosing version of Soliris that offers improved dosing convenience.

 

Both Soliris and its biosimilar are administered intravenously every 2 weeks.

 

In this regard, Samsung Bioepis believes that there is enough market potential as there is still a demand for Soliris in the medical field and there are many markets where Ultomiris has not entered yet.

 

“Teva is a generic and biosimilar company with extensive sales and marketing infrastructure in the U.S.

 

market,” said a Samsung Bioepis official.

 

”We chose Teva as our commercialization partner for Epysqli in the U.S.

 

market because of its experience and expertise in the U.S.

 

market.” The official added, “The market for Soliris is much larger in the U.S.

 

than in Europe, and we are excited to see how Epysqli will sell in the U.S.

 

given its success in Europe.”