Biosimilars/News

FDA approval for Amgen’s adalimumab biosimilar

Biosimilars/News | Posted 30/09/2016

The US Food and Drug Administration (FDA) announced on 23 September 2016 that it had approved Amgen’s biosimilar version of AbbVie’s arthritis blockbuster Humira (adalimumab).

Australia says etanercept biosimilar can be substituted

Biosimilars/News | Posted 30/09/2016

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has decided that the etanercept biosimilar Brenzys ‘could be marked as equivalent’ to the brand-name biological Enbrel on the Australian Pharmaceutical Benefits Scheme (PBS).

FDA approves biosimilar etanercept Erelzi

Biosimilars/News | Posted 23/09/2016

The US Food and Drug Administration (FDA) announced on 30 August 2016 that it had approved Sandoz’s biosimilar version of Amgen/Pfizer’s arthritis blockbuster Enbrel (etanercept).

Canadian approval for etanercept biosimilar

Biosimilars/News | Posted 16/09/2016

Merck Canada announced on 12 September 2016 that it had received approval for its etanercept biosimilar Brenzys (SB4) from Health Canada – the first subcutaneous anti-tumour necrosis factor (anti-TNF) biosimilar available in Canada.

Mylan and Biocon submit trastuzumab biosimilar to EMA

Biosimilars/News | Posted 09/09/2016

Mylan and Biocon announced on 25 August 2016 that the regulatory submission for their proposed trastuzumab biosimilar (MYL-1401O) had been accepted for review by the European Medicines Agency (EMA).

FDA accepts application for Merck’s follow-on insulin glargine

Biosimilars/News | Posted 02/09/2016

US pharma giant Merck announced on 5 August 2016 that its regulatory submission for its proposed follow-on insulin glargine product (MK-1293) had been accepted by the US Food and Drug Administration (FDA).

Janssen Biotech files lawsuits for infringement of cell culture media patent

Biosimilars/News | Posted 26/08/2016

In ongoing litigation over infliximab biosimilars, Janssen Biotech, manufacturer of Remicade (infliximab), has filed two new lawsuits against Celltrion Healthcare, Hospira and HyClone Laboratories, a subsidiary of GE Healthcare Life Sciences, over the use of cell cultures grown for use in Celltrion’s biosimilar Remsima (infliximab), and Hospira’s biosimilar Inflectra (infliximab).