- Korean biosimilars manufacturer Samsung Bioepis Co Ltd. said it will team up with Japanese drugmaker Takeda Pharmaceutical Company to jointly develop new biologic therapies, venturing into novel drug development for the first time since launching roughly five years ago.
- Together, the drugmakers will co-fund and co-develop multiple biologic medicines, beginning with a candidate for severe acute pancreatitis. Further details of the collaboration were not disclosed.
- 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.
Samsung Bioepis has so far found quick success, winning 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.
Biosimilars have attracted investment from both niche players including Samsung and its rival Korean firm Celltrion, Inc. as well as big pharmas such as Amgen and Merck & Co. Patent protection for many leading biologics is either expiring or will soon lapse, opening up billion dollar revenue streams to new competition.
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.
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.
Indeed, Samsung has already played a part in that potential shift. Merck, which commercializes Samsung's biosimilar Remicade under a partnership, priced the copy at a 35% discount to brand, undercutting Pfizer Inc.'s version. That should help commercial uptake, but a sustained move toward generic-like discounts could make the space less attractive overall.
Diversifying to novel biologics could help pad against such developments, even as Samsung continues to push on biosimilars with second and third "waves" of new biosimilar candidates.
The deal with Takeda is the first step to develop "end-to-end" capabilities in drug development. And moving forward, Samsung Bioepis says it "will continue to look for additional co-development opportunities with multinational pharmaceutical and biotech companies."