Janssen Biotech has taken Samsung Bioepis to court in the U.S., accusing the Korean company of violating patents for its top-selling drug. Analysts said Sunday Janssen appeared to be trying to delay a Samsung biosimilar drug's entry into the U.S. market.
In April, Samsung won approval from the U.S. Food and Drug Administration to sell Renflexis -- its biosimilar of Janssen's blockbuster rheumatoid arthritis medicine Remicade. It was expected to go on sale in the world's largest pharmaceutical market late this year.
Samsung Bioepis said Janssen, a subsidy of healthcare conglomerate Johnson & Johnson, filed a lawsuit in the U.S. District Court of New Jersey last week, claiming Samsung has infringed on three of its patents. It also asks for damages. Remicade generates nearly $5 billion (5.59 trillion won) in sales a year.
"Janssen's patent lawsuit is an anticipated step. We will continue to proceed with the U.S. launch of Renflexis as planned," a Samsung official said. "Janssen takes issue with the same patents as it did with Celltrion's Inflectra."
Janssen last year filed a lawsuit against Celltrion, a cross-city rival of Samsung Bioepis, with another Remicade biosimilar named Inflectra. The Patent Trial and Appeal Board ruled in favor of the Korean company, which released the medicine in the U.S. market last November.
Observers expect that the legal action would not delay or prevent the U.S. market launch of the Samsung product, which Merck will take to market in November at the earliest.
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