Samsung Bioepis faces patent suit by Amgen

Samsung Bioepis, an affiliate of Samsung Group specialising in developing biosimilars, or cheaper, generic copies of biologic drugs, has been sued by US-based pharmaceutical giant Amgen for patent infringement in Canada.

Amgen Canada filed for a prohibition order on July 31, 2015, claiming Brenzys, Samsung Bioepis' biosimilar copy of Amgen's blockbuster rheumatoid arthritis treatment Enbrel (Etanercept), breached two patents held by Amgen, according to Canadian court documents and Samsung Bioepis on Monday.

Amgen's legal measures, perceived as a move to delay market competition, came just months after the South Korean drugmaker submitted an approval request to the Canadian health authorities in May 2015 to begin selling its Enbrel biosimilar in the country.

The two Canadian patents held by Amgen are related to Enbrel's formulation (CA 2,476,934) -- polypeptides containing immunoglobulin -- and treatment method (CA 2,366,785) of using elevated tumour necrosis factor alpha receptors.

"Patent infringement lawsuits by the original drugmakers are common when a biosimilar drug seeks to gain sales approval in new overseas markets, including in Canada," a company spokesperson told The Korea Herald.

Every country has differing regulations governing the sales of subsequent entry biologics, or biosimilars, and in Canada, this process includes simultaneously reviewing the biosimilar and patents held by the original drug developer, according to Samsung Bioepis.

"In filing our sales approval request, we clarified our stance that we did not infringe on (Amgen's) patents," the spokesperson said. "Samsung Bioepis abides by the position of noninfringement."

Meanwhile, Amgen alleges that Samsung Bioepis violated its two patents. The US drugmaker's formulation patent in Canada reportedly remains effective until 2024, though the company's Canadian patent on Etanercept expired last year.

Industry watchers generally do not expect the pending lawsuit between the two drugmakers in Canada to significantly impact Samsung Bioepis' plans to list on the US Nasdaq, which analysts expect in June.

"Since multiple biosimilars developed by Samsung Bioepis are awaiting approval in various countries and regions, the firm's IPO plan will likely remain unhampered by the current lawsuit," said SK Securities analyst Roh Kyung-chul.

Samsung's biosimilar copies of Remicade and Lantus, both among the world's top-selling biologic drugs, are close to gaining final sales approval in the US and Europe, Roh said, adding these two drugs are not subject to patent issues.

At the same time, delays in commercializing its Enbrel biosimilar overseas, which comprises a major portion of Samsung Bioepis' immediate sales outlook, could potentially drive down the firm's market value and initial public offering price, according to the SK analyst.

While facing legal hurdles in Canada, Samsung's Enbrel biosimilar Brenzys -- to be marketed as Benepali in Europe, was recently recommended for approval by the European Medicines Agency in November 2015.

Brenzys has also begun commercial sales in Korea, upon gaining approval by the country's Ministry and Drug Safety in December 2015.

When asked about the possibility of patent suits that may block the drug's sales in Europe, the Samsung Bioepis spokesperson said that "legal regulations concerning biosimilar drug sales in the region are different from that of Canada."

As for launching its Enbrel biosimilar in the United States -- which together with Canada accounts for about 50 per cent of the global biologics market -- Samsung Bioepis said it is "planning to submit the drug for approval by the US Food and Drug Administration soon, though no visible steps have been taken as of now."

However, commercializing the Enbrel biosimilar in US markets in the near future will be difficult, as Amgen successfully obtained a new patent (US 8,063,182) in 2011 to extend the original drug's patent protection deadline to Nov. 22, 2028.

At the time, the news prompted US-based pharma giant Merck Co. to call off a licensing deal on an Enbrel biosimilar in development by Hanwha Chemical, prompting the Korean drugmaker to pull out from the segment.

Eyeing robust growth in the coming decade, drug developers around the world, including Samsung, have jumped into the development of biosimilars.

This new segment of replicated biologic treatments is expected to grow into a multibillion-dollar industry in the years to come. Market analyst Research and Markets forecasts that biosimilars will reach annual sales of $32 billion worldwide by 2025.