The World Health Organization is to pilot the prequalification of biosimilars in a bid to make expensive cancer treatments more widely available to patients. Ritixumab and trastuzumab will be first in line. The EU generics and biosimilars industry has welcomed the initiative, saying the introduction of biosimilars in the field of oncology could lead to significant changes to standards of care for patients.
In order to make biotherapeutic medicines more accessible and affordable, the World Health Organization plans to assess and pre-qualify biosimilar versions of two anti-cancer drugs on its essential medicines list - rituximab for the treatment of non-Hodgkin's lymphoma and chronic lymphocytic leukemia, and trastuzumab for the treatment of breast cancer.
In addition, the WHO will explore options for prequalifying insulin.
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.
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.
