European SPC Manufacturing Waiver Comes Into Effect
Timeline: Key Events For The Development Of A Waiver To Allow Manufacturing And Stockpiling For Day-One Launch
In Vivo has traced the history of the newly affirmed European SPC manufacturing waiver from early industry lobbying efforts to its ultimate entry into force. The mechanism has been met with controversy throughout its evolution.
You may also be interested in...
A strong case exists for a more tailored approach to biosimilars development that could increase regulatory efficiency and broaden access, Sandoz’ head of biopharmaceuticals, Pierre Bourdage, tells Generics Bulletin in an exclusive interview.
Dr Reddy’s has shaken up the market for generic Vascepa in the US by launching its own icosapent ethyl capsules to compete with Hikma’s generic and the Amarin brand, hot on the heels of the Supreme Court’s rejection of the originator’s attempt to overturn a Federal Circuit decision invalidating six Vascepa patents.
Sawai is lining up eight launches as part of the Japanese company’s strategy to capture an increased share of its domestic generics market.