ARTICLES BY ESTEL GRACE MASANGKAY
-
![Sandoz’ Biosimilar A Suitable Alternative To Amgen’s Neupogen]( "Sandoz' Biosimilar A Suitable Alternative To Amgen's Neupogen")
Sandoz' Biosimilar A Suitable Alternative To Amgen's Neupogen12/10/2014Novartis company Sandoz reported late-stage data showing that its investigational biosimilar filgrastim has comparable safety and efficacy to its reference product Neupogen (filgrastim) by rival company Amgen.
-
![blueredwhitepills450x300]( "ABPI, BIA Release FAQ And Guide To Biosimilars")
ABPI, BIA Release FAQ And Guide To Biosimilars7/24/2014As biosimilars rise to prominence in the pharmaceutical industry, the Association of the British Pharmaceutical Industry (ABPI) and the Bioindustry Association (BIA) have jointly worked on developing materials on biological drugs including biosimilars. The documents include a guide to the medicines and a collection of frequently asked questions.
-
![approvedpills450x300]( "Oncobiologics Secures EU Approval For Humira Biosimilar Trial")
Oncobiologics Secures EU Approval For Humira Biosimilar Trial6/16/2014Oncobiologics announced that it has secured approval in the EU to start a Phase I clinical trial for its Humira biosimilar molecule ONS-3010.
-
![colorfulpills450x300]( "Oncobiologics And Ipca Establish New Biosimilars Alliance")
Oncobiologics And Ipca Establish New Biosimilars Alliance6/5/2014Oncobiologics announced that it has entered into a two-part collaboration with Ipca Laboratories for the development, manufacture, and sales of biosimilar monoclonal antibody candidates. No financial details were disclosed by either company.
-
FDA Releases Draft Guidance On Biosimilars5/19/2014
The U.S. Food and Drug Administration (FDA) has released its first new biosimilar guidance to help sponsors with the design and use of clinical pharmacology studies in order to determine a proposed biological product’s biosimilarity to its reference.
-
![Russia Regulators Approve First mAb Biosimilar]( "Russia Regulators Approve First mAb Biosimilar")
Russia Regulators Approve First mAb Biosimilar5/19/2014The Russia Ministry of Health has issued a positive opinion for AcellBia, BIOCAD’s rituximab biosimilar. AcellBia is the first mAb biosimilar to be approved by Russian regulators.
-
![Formycon AG Reports Outlicensing Of First Biosimilars Project]( "Formycon AG Reports Outlicensing Of First Biosimilars Project")
Formycon AG Reports Outlicensing Of First Biosimilars Project3/13/2014Biosimilars developer Formycon AG reported that it has ended the year 2013 with out licensing of its first biosimilars development project.
