Read our latest updates & insights

MabTech announces successful Chinese Ph III clinical trials for Sorrento’s “biosimilar/biobetter” cetuximab STI-001, and infliximab STI-002.

Health Canada confirms Authorisation of Filgrastim biosimilar Grastofil®.

Hospira’s biosimilar infliximab becomes the first biosimilar infliximab to be PBS listed in Australia.

Amgen submits BLA under s351(k) pathway for ABP 501 (proposed adalimumab biosimilar).

Samsung Bioepis announces Brenzys® (SB4), biosimilar etanercept received approval in South Korea with launch intended late 2015/early 2016.

Sandoz launches filgrastim biosimilar Zarxio® in US.

Sandoz biosimilar Zarxio® approved for US sale with the same indications as Neupogen®, and with a “placeholder” name “figrastim-sndz”.  This is the first approval of a biosimilar product in the US.

Canadian drug manufacturer Apotex announces FDA has accepted for filing its Biosimilar application for Filgrastim (Grastofil®) along side previous patent Neupogen® within the US Marketplace.

FDA accepts Apotex’s s351(k) application for biosimilar Neulasta.

US based manufacturer granted approval from EMA to distribute filgrastim biosimilar Accofil®.