The European Union has announced that it will accept a reference product for a biosimilar application from countries with robust regulatory systems and similar guidelines, a move that should significantly boost the domestic biosimilars industry.
Lundbeck becomes the latest company in Europe to announce job cuts, as austerity, generic competition and unclear pricing and reimbursement practices create uncertainties.
Sir Michael Rawlins talks about his views on EuroNICE, PCORI and the future of health technology assessment as he prepares to step down after nearly 14 years as chairman of the U.K.'s cost regulator, the National Institute for Health and Clinical Excellence.
The Executive Director of the European Medicines Agency Guido Rasi’s dual goals of increasing safety and overall accountability undoubtedly will benefit patients and industry alike, but a grueling task lies ahead.
