Protocols

Samsung Bioepis launches a Remicade knockoff at a 35% discount; FDA OK’s a self-administered version of Benlysta

→ The South Korean biosimilar player Samsung Bioepis has launched a copycat of Remicade on the US market at a 35% discount to J&J’s list price for that therapy. Remicade is J&J’s top earner, and the pharma giant has filed suit to try and stop Samsung’s rival for being introduced. There’s been considerable speculation on how generic versions of biologics could impact pricing.

→ The FDA approved a subcutaneous formulation of Benlysta for lupus, making it possible for patients to switch from an IV version of the GSK drug to a self-administered shot.

→ Oxford-based e-Therapeutics — which once tried to develop extended release tramadol as an antidepressant — is punting four pipeline projects, narrowing its focus to two programs in immuno-oncology and staking its future on building a reputation for computer-driven drug discovery work.


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RAPS Regulatory Convergence 2017