Samsung Bioepis Gets US Adalimumab Nod
Samsung Bioepis has become the first company to receive FDA approvals for biosimilars of all three first-generation anti-TNF biologics after gaining a nod for its Hadlima biosimilar adalimumab.
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Samsung Bioepis and Organon have revealed plans to compete with higher-concentration formulations of adalimumab in the US, after the FDA accepted for review an sBLA for a citrate-free 100mg/ml version of the SB5 Hadlima biosimilar that is already approved in a 50mg/ml formulation.
In the first part of an exclusive interview with Generics Bulletin, Samsung Bioepis CEO Christopher Hansung Ko sets out his views on the US biosimilar market.
Samsung Bioepis has entered a fifth continent by launching its Brenzys etanercept biosimilar in Brazil, as part of global expansion plans for the business.