Given the pressing need for more affordable versions of complex drug products like peptides, liposomes, transdermals and metered dose inhalers, FDA is encouraging generic drug companies to submit more applications for generic alternatives. FDA encourages industry to leverage agency-sponsored research for more advice on how to submit applications that will get approved.
There is a need for more generic alternatives for complex drug products, and industry should not be deterred by some of the well-known challenges in developing them, a US FDA official told a recent conference. Instead, she said manufacturers should consult the product-specific guidance available for some of these products and leverage agency-sponsored research.
Concerns about the lack of generic availability of complex drugs were aired at a Sept. 12-13 FDA-sponsored workshop in Silver...
The Philippines medicines regulator explains how it intends to implement the ASEAN mutual recognition agreement under which member states have committed to accept bioequivalence study reports for generics issued by approved BE centers.
Private Company Edition: June’s eight $100m-plus venture capital rounds already outpace the seven each raised in March, April and May, including €255m ($274.2m) for ITM and $200m for Upstream, but while there were five $25m or less VC financings during the past week, mid-sized deals were lacking.
Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.
A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.
Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.
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.
