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 U.S. 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.
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 percent of the global biologics market -- Samsung Bioepis said it is “planning to submit the drug for approval by the U.S. Food and Drug Administration in the future, though no visible steps have been taken as of now.”
However, commercializing the Enbrel biosimilar in U.S. 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 U.S.-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.