Biosimilars

Boehringer Ingelheim’s adalimumab biosimilar ‘equivalent’ to Humira

Biosimilars/Research | Posted 23/06/2017

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

Biosimilars/General | Posted 23/06/2017

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

Biosimilars/Research | Posted 16/06/2017

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

Biosimilars/General | Posted 16/06/2017

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

Biosimilars/News | Posted 16/06/2017

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

Biosimilars/News | Posted 16/06/2017

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

Biosimilars/News | Posted 09/06/2017

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

Biosimilars/Research | Posted 09/06/2017

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.

Predictive modelling of CIN prophylaxis with biosimilar filgrastim

Biosimilars/Research | Posted 09/06/2017

Granulocyte colony-stimulating factors (G-CSF) stimulate white blood cell production and as such are indicated in the prophylaxis of chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN). Risk models of CIN/FN to date focus on predictors measured at the start of chemotherapy. Aapro and colleagues used a dynamic approach of CIN/FN risk modelling at the start of each cycle.

EMA accepts application for adalimumab biosimilar from Fujifilm Kyowa Kirin Biologics

Biosimilars/News | Posted 02/06/2017

Japan-based biosimilars developer Fujifilm Kyowa Kirin Biologics announced on 22 May 2017 that its application for approval for its proposed adalimumab biosimilar (FKB327) had been accepted by the European Medicines Agency (EMA).