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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®.

CA approval for Celltrion/Hospira’s infliximab biosimilar products to be marketed as Remsima® and Inflectra®.

EMA welcomes Apotex’s biosimilar Filgrastim rendition, Grastofil®, throughout Europe.

Hospira/Celltrion’s infliximab biosimilar products approved in EU (Remsima® and Inflectra®).

Stada and Gedeon Richter announce collaboration deals to develop and sell biosimilars rituximab and trastuzumab.

European Commission (EC) withdraws EU marketing authorisation following Filgrastim Ratiopharm® MAH’s voluntary withdrawal.

A Biosimilar product of Filgrastim was approved by the European Commission and marketed across several European countries under the name of Nivestim®.

Tanvex submits New Drug Submission to Health Canada for biosimilar filgrastim.