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During the annual European Association of Hospital Pharmacists meeting in Milan, Italy, in March 2012, 600 pharmacists attended the European Generic medicines Association (EGA) symposium entitled ‘Biosimilar monoclonal antibodies: the next frontier’. The symposium highlighted the established safety and efficacy profile of biosimilars, the stringent regulations surrounding their European manufacture and approval, and their cost-effectiveness compared with their reference products. It also noted the imminent introduction of biosimilar monoclonal antibodies (mAbs). This symposium was co-sponsored by Hospira, Sandoz and Teva.
Chairing the symposium, Professor Dr Theodor Dingermann, from Goethe University, Frankfurt am Main, Germany, said that a highly controlled, consistent manufacturing process is intrinsically important in order to ensure the efficacy and safety of both biologicals and biosimilars. He noted that the future of biosimilars now lies with mAbs.
Dr Jan Müller-Berghaus, Head of the Monoclonal and Polyclonal Antibodies Section at the Paul-Ehrlich Institute, Germany, a co-opted member of the Committee for Medicinal Products for Human Use (CHMP) and member of the European Medicines Agency (EMA) Scientific Advice Working Party, outlined the history behind, and contents of, the draft EMA ‘Guideline on biosimilar mAbs’. He explained some of the challenges of preparing this draft, including:
▶ General considerations on equivalence versus non-inferiority
▶ Exploring the best way to compare mAb biosimilars with their reference product in terms …
Competing interests None.
Funding Financial support for the satellite symposium was provided by an educational grant from Hospira, Sandoz and Teva.
Provenance and peer review Commissioned; internally peer reviewed.