Biosimilars
Marketing authorization for NBCDs in the EU
The regulatory body for approval of medicines in the European Union (EU) is the European Medicines Agency (EMA). The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU and this also includes non-biological complex drugs (NBCDs).
EC approval for adalimumab biosimilar Amgevita
Biotech giant Amgen announced on 23 March 2017 that the European Commission (EC) had granted marketing authorization for its adalimumab biosimilar Amgevita.
The European Pharmacopoeia monographs for biotherapeutic products
European Pharmacopoeia (Ph. Eur.) monographs for biologicals have existed since the 1990s and remain the publicly available standard defining the quality of these medicines. Continued development of such monographs, however, faces considerable challenges and the value and utility of these monographs have been questioned in recent years. What such challenges are and how they can be overcome is discussed by Head of Division of the European Pharmacopoeia Department at the EDQM, Dr Emmanuelle Charton, in a GaBI Journal paper [1].
FDA biologicals naming guidance could cost providers billions
Healthcare organizations have expressed their ‘grave concerns’ over the ‘enormous financial consequences’ of the US Food and Drug Administration’s (FDA) guidance on naming of biologicals.
Amgen submits trastuzumab biosimilar to EMA
Biotech giant Amgen announced during a conference presentation that it had filed for marketing approval for its trastuzumab biosimilar (ABP 980) in the European Union (EU).
Study of top-down infliximab use in children with Crohn’s disease
The Erasmus Medical Center, in collaboration with the Netherlands Organisation for Health Research and Development and biosimilars maker Hospira, now Pfizer, is carrying out a study to investigate the benefits and risks of the use of infliximab as first-line use for children with active perianal fistulising Crohn’s disease [1].
Evidence on biosimilar efficacy and safety leads to ASAS/EULAR recommendation
A study of biological disease-modifying anti-rheumatic drugs (DMARDs) in patients with axial spondyloarthritis (axSpA) found no reason for physicians not to prescribe infliximab biosimilars [1].
Pharma associations issue position paper on biosimilar switching
The European Federation of Pharmaceutical Industries and Associations (EFPIA), European Biopharmaceutical Enterprises (EBE) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) have issued joint guidance for prescribers on switching between originator biologicals and biosimilars.
Improving efficacy of biologicals without increasing cost
Biologicals targeting antitumour necrosis factor-α, such as Remicade (infliximab) and Humira (adalimumab), have been used for the treatment of chronic inflammatory diseases for many years. The advent of biological therapies raised significant pharmacoeconomic concerns, because the cost of biological treatment is much higher than the cost for conventional treatments, typically Euros 10.000‒20.000 per patient per year. This is an issue discussed by Professor Ann Gils from the Department of Pharmaceutical Sciences, KU Leuven, Belgium [1].
Global settlement clears a pathway for trastuzumab biosimilar
Generics giant Mylan Pharmaceuticals (Mylan) announced on 13 March 2017 that it had agreed to the terms of a global settlement with Genentech and Roche in relation to patents for Herceptin (trastuzumab), which provides Mylan with global licences for its trastuzumab biosimilar.
