Samsung Bioepis and Takeda’s Co-development deal for novel biologics

Korean biosimilars manufacturer Samsung Bioepis Co Ltd. will team up with Japanese drugmaker Takeda Pharmaceutical Company to jointly develop new biologic therapies.

Together, the drugmakers will co-fund and co-develop multiple biologic medicines, beginning with a candidate for severe acute pancreatitis.

Up until now, Samsung Bioepis has focused solely on building a pipeline of biosimilar copies to existing treatments in a bid to break into the high-value market for biologics. The deal with Takeda will broaden the company’s capabilities, but move into the riskier and more costly business of inventing new drugs.

Present Status: 

• Unlike generic development, however, making biosimilars is not a cheap endeavor. Samsung Bioepis has invested $1.3 billion in R&D since 2012, and mass-producing copies of biologic drugs is more costly than cranking out batches of chemically identical pills.
• Samsung Bioepis has approval of two biosimilars in Europe and another in the U.S.
• In Europe, its copy of Amgen, Inc.’s Enbrel (etanercept) was the first biosimilar of the blockbuster drug to clear regulatory review. Marketed as Benepali by Samsung’s partner Biogen, Inc, the drug has earned $250 million in sales since its approval and launch in January 2016, according to company spokesperson Mingi Hyun.
• European approval of its biosimilar of Remicade (infliximab) followed several months later in May of last year.
• Samsung is currently awaiting a green light from the European Commission for its biosimilar of AbbVie Inc.’s Humira (adalimumab). Authorization by the EC would make Samsung the first company to win regulatory approval in Europe for biosimilars of all three top-selling TNF-inhibitors: Humira, Enbrel and Remicade.
• In the U.S., Samsung has moved a bit slower, notching an approval for its Remicade copy this past April. But the U.S. market has only just begun to emerge, and the company figures to be competitive there as well.

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Currently, biosimilars in the U.S. have been launched at relatively modest discounts to the original branded drugs — leaving substantial room for hefty profit margins. However, as more biosimilars enter the market, that could change and lower the potential return on investment. Learn from a Bisosimilar pricing case study >> View Case Study