As agency's hearing approaches, a Pink Sheet graphic charts the path for pending and approved applications for insulin, human growth hormone, and certain other protein products when the BPCIA ‘transition provisions’ take effect in March 2020.
The complex process by which dozens of protein products will shift from regulation as drugs to biologics in March 2020 may face renewed scrutiny at an upcoming US Food and Drug Administration hearing on biosimilar and interchangeable insulins.
Under the Biologics Price Competition and Innovation Act “transition provisions,” insulin, human growth hormone and certain other types of protein...
The fall start of PDUFA and GDUFA negotiations could impact the agreement review process and other parts of the schedule intended to ensure it reaches Congress on time.
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.
Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.
Aurobindo is confident its planned Lannett acquisition will meet US FTC standards after an attempt to acquire Sandoz assets was nixed in 2020. The deal also could widen Aurobindo’s US manufacturing presence.
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.
