Pfizer and Celltrion agreed not to market Inflectra, their biosimilar to Janssen's blockbuster TNF-inhibitor, before mid-September barring certain circumstances.
Janssen Biotech Inc. has succeeded in pushing back the earliest launch date for Pfizer Inc.'s biosimilar to Remicade (infliximab), though it may still come sooner than Janssen wishes.
Celltrion Inc. and US marketing partner Pfizer previously agreed not to launch Inflectra (infliximab-dyyb) in the US before June...
The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?
The importance of generic and biosimilar medicines is being recognized by the UK government for the first time. However, Mark Samuels, CEO of Medicines UK, the trade body representing the off-patent industry, says companies are still face multiple hurdles in the market.
The UK drug regulator is collecting data to establish whether patients who are hospitalized for acute pancreatitis after taking a GLP-1 drug have a genetic predisposition to this side effect. If a “clear link” is found, the MHRA would consider regulatory action.
