Biosimilars & Generics

We’ve all been told that walking 10,000 steps a day is the magic number for better health. But what if the real secret to walking more isn’t about counting steps at all? In this article, we explore how focusing on motivation, environment, and mindset can help you build a walking habit that lasts.

The bispecific antibody is the latest example of a growing number of biologics receiving complete response letters related to third-party manufacturing facilities.

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.

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.

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.