Biosimilars/News
FDA accepts application for pegfilgrastim biosimilar from Coherus
Coherus BioSciences (Coherus) announced on 6 October 2016 that the US Food and Drug Administration (FDA) had accepted for review a Biologics License Application (BLA) for the company’s pegfilgrastim biosimilar candidate (CHS-1701).
Baxalta and Momenta part ways on adalimumab biosimilar
US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 27 September 2016 that it would regain rights to its candidate adalimumab biosimilar M923 from Baxalta, a spinoff company from Baxter International.
Biogen’s infliximab biosimilar gets UK launch
US biotechnology company Biogen has launched their biosimilar of blockbuster anti-inflammatory Remicade (infliximab) across the UK.
Pfizer to launch infliximab biosimilar Inflectra in US
Pfizer announced on 17 October 2016 that it will begin shipment of its monoclonal antibody biosimilar Inflectra (infliximab-dyyb) to the US in late November 2016.
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).
