Biosimilars
Biosimilars and sustainability
Competition between brand-name biologicals and biosimilars has the potential to reduce future cancer costs, according to researchers from Italy [1].
EC approval for rituximab biosimilar Rixathon
Sandoz, the generics division of Novartis, announced on 19 June 2017 that it had received European Commission (EC) approval for its biosimilar rituximab product Rixathon.
Boehringer Ingelheim’s adalimumab biosimilar ‘equivalent’ to Humira
Germany-based biologicals specialist Boehringer Ingelheim (Boehringer) announced on 14 June 2017 positive results from its pivotal phase III study of its candidate adalimumab biosimilar.
UK investigation suggests Merck broke competition law
A provisional statement from the UK Competitions and Markets Authority (CMA) says that Merck Sharp & Dohme (MSD) ran an anticompetitive discount scheme for anti-inflammatory drug Remicade (infliximab).
Biosimilar infliximab safe and effective in IBD
A systematic review and meta-analysis of Celltrion/Hospira’s infliximab biosimilar, Remsima/Inflectra found it to be safe and effective in the treatment of inflammatory bowel diseases (IBD) [1].
Recommendations to enhance transparency of biosimilar labels
On 6 June 2017, the European Association for Bioindustries (EuropaBio) announced that it had ‘developed recommendations for changes to the Summary of Product Characteristics (SmPC) of biosimilars that would result in an enhanced level of transparency in the label’.
FDA advisors recommend approval of Pfizer’s epoetin alfa biosimilar
US Food and Drug Administration’s (FDA) advisers have voted to recommend the approval of Pfizer’s biosimilar version of Amgen/Johnson & Johnson’s Epogen/Eprex/Procrit (epoetin alfa).
Celltrion making progress with biosimilars in China and Japan
South Korean biotechnology company Celltrion has announced advances in its biosimilar rituximab and trastuzumab programmes in China and Japan.
FDA advisory committee to review bevacizumab and trastuzumab biosimilars
The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) announced in a Federal Register Notice on 7 June 2017 that it would be reviewing bevacizumab and trastuzumab biosimilars at its next meeting.
Infliximab biosimilar coming closer to interchangeability
Three studies presented at the Digestive Disease Week (DDW) 2017 have shown no significant differences in efficacy or safety endpoint. Two of the studies also specifically tested outcomes in patients switching from the originator infliximab product, Remicade, to the biosimilar version.
