Biosimilars/News
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.
EMA recommends approval of infliximab biosimilar Flixabi
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 1 April 2016 that it had recommended granting of marketing authorization for a biosimilar infliximab product (SB2).
Samsung Bioepis adalimumab biosimilar submitted to EMA
South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 18 July 2016 that its adalimumab biosimilar candidate, SB5, had been accepted for review by the European Medicines Agency (EMA).
FDA rejects Sandoz’s biosimilar pegfilgrastim application
Novartis disclosed on 19 July 2016 that the application by its Sandoz unit to market a biosimilar version of pegfilgrastim has been rejected by the US Food and Drug Administration (FDA).
