The FDA has issued 36 draft product-specific guidances for generic drug development, comprising 19 new guidances and 17 revised documents.
A raft of fresh product-specific guidances for generic drug development has been published by the US Food and Drug Administration at the start of September, with the 36 draft guidances published by the agency offering 19 new PSGs and 17 revised documents.
Among the new draft PSGs are documents covering amlodipine suspension, injectable bortezomib and lefamulin and gallium DOTATOC Ga 68...
The EMA’s Committee for Medicinal Products for Human Use has issued positive opinions for multiple aflibercept and ustekinumab biosimilars, intensifying competition for Eylea and Stelara respectively in Europe. Meanwhile, a Biocon subsidiary also received a nod for a Neulasta biosimilar.
In a further setback for generics manufacturers, the District Court of The Hague has upheld the validity of a key Xtandi (enzalutamide) patent and its Dutch supplementary protection certificate, rejecting Sandoz and Accord’s challenge based on lack of inventive step.
As Medicines for Europe gears up for a pair of conferences in Brussels next week, the organization has set out trade policy recommendations to strengthen access to medicines and the competitiveness of EU manufacturing, in a seminar with representatives from the European Commission and member states.
