Biosimilars/News
EMA accepts application for trastuzumab biosimilar
Samsung Bioepis, which is a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen, announced on 3 October 2016 that its regulatory submission for its proposed trastuzumab biosimilar (SB3) had been accepted for review by the European Medicines Agency (EMA). The company says the marketing application was submitted in August 2016.
FDA approval for Amgen’s adalimumab biosimilar
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
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
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
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
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
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
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).
Mylan and Biocon submit pegfilgrastim biosimilar to EMA
Mylan and Biocon announced on 21 July 2016 that the regulatory submission for their proposed pegfilgrastim biosimilar (MYL-1401H) had been accepted by the European Medicines Agency (EMA).
Bevacizumab similar biologics launched in India
Generics makers Reliance Life Sciences (Reliance) and Hetero have both launched similar biologics of Roche’s blockbuster cancer therapy Avastin (bevacizumab) in India.
