In July WHO launched its pilot project for prequalifying biotherapeutic medicines. This project constitutes a step towards promoting greater access to expensive cancer treatments in low- and middle-income countries. To that end, WHO is inviting manufacturers to submit applications for prequalification of two biotherapeutic products in the WHO Essential Medicines List: rituximab (used principally to treat non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia), and trastuzumab (used to treat breast cancer) and their corresponding similar biotherapeutic products (SBPs).
“Biosimilars represent effective cancer treatment options at a more affordable price”, says Mariângela Simão, WHO Assistant Director General, Access to Medicines, Vaccines, Pharmaceuticals. The specialist highlighted the need to ensure the quality and safety of these products, explaining that “prequalification will be a key step to expanding access to these medicines”.
WHO Opens Consultation on New Biosimilar Q&A
The World Health Organization (WHO) launched a consultation on a draft document titled WHO Questions and Answers: Similar Biotherapeutic Products. The document, which outlines answers to questions regulators posed over the past eight years, is part of a plan to clarify earlier biosimilar guidance and comments will be received until 20 September. The Q&A follows the 2009 “Guidelines on evaluation of similar biotherapeutic products (SBPs)” and another 2016 guideline on monoclonal antibody biosimilars.
The document – which focuses mostly on quality and clinical evaluation – covers a range of topics, from basic concepts to more complex questions, like: “Would it be beneficial to review/discuss post-marketing commitments from each NRA (national regulatory authority) after extrapolation of indications?”
The Q&A is divided into six sections:
- Concept for licensing similar biotherapeutic products;
- Reference biotherapeutic products;
- Quality;
- Nonclinical evaluation;
- Clinical evaluation;
- Pharmacovigilance.