Industry calls for more education amid concerns that brand sales reps are encouraging providers to use only interchangeable products because they are better than biosimilars.
Biosimilar sponsors are worried that interchangeability, or lack thereof, could be used against them by reference product manufacturers to limit uptake and question product quality.
Because interchangeability is considered a higher bar for FDA approval than biosimilarity, sales representatives, presumably for innovator products, have suggested...
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.
A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.
