Meenu Wadhwa | Head, Biosimilars section
MHRA

Meenu Wadhwa heads a team in the R&D Biotherapeutics and Advanced Therapies group at the MHRA, UK. Areas of interest are development and application of assays – potency, bioanalytical (e.g., cytokines and related products, anti-drug antibody assays), biosimilars, unwanted immunogenicity and predicting adverse effects of biotherapeutics. This has led to development of WHO reference standards for various therapeutics, anti-drug antibodies, publications and presentations at conferences. She works closely with the WHO, different pharmacopoeias informally or as an expert member (e.g., EDQM committees), regulatory and control laboratories, professional societies (member of standardisation committee e.g., International Cytokine and Interferon society, International Union of Immunological society) and the WHO where she has contributed to the drafting of several guidelines including biosimilars. Previously, she participated in EMA Biologics Working Party and Biosimilar medicines Working Party meetings and was involved in the drafting of some of the EMA guidelines (e.g., biosimilars, immunogenicity assessment). She supports the licensing teams, where possible, in reviewing bioanalytical assays for product approval. She reviews manuscripts for journals and serves as an associate editor for the journal Biologicals.