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European approval for biosimilar insulin posted 15/09/2014

Partners Eli Lilly and Boehringer Ingelheim, announced on 10 September 2014 that they had received European Commission (EC) a...

Infliximab biosimilar to be distributed by Mundipharma posted 05/09/2014

Celltrion’s infliximab biosimilar Remsima will be distributed in Belgium, Germany, Italy, Luxembourg, The Netherlands and UK,...

FDA receives application for monoclonal antibody biosimilar posted 29/08/2014

South Korean biotechnology company Celltrion announced on 11 August 2014 that the company had, on 8 August 2014, completed th...

FDA grants tentative approval for insulin treatment posted 25/08/2014

On 18 August 2014, the US Food and Drug Administration (FDA) granted tentative approval for a new insulin glargine product (L...

More biosimilars collaborations on the cards posted 25/08/2014

Collaborations for biosimilars are still in vogue, with the latest companies making deals being PlantForm Corporation (PlantF...

 

Research

Regulating the safety of biosimilars posted 17/09/2014

Clinical safety is critically important during the development of a biosimilar. An overview of the main aspects of safety ass...

Adalimumab biosimilar has comparable pharmacokinetics to Humira posted 05/09/2014

An adalimumab biosimilar (CHS-1420) from fledgling biotech company Coherus Biosciences (Coherus) has shown comparable pharmac...

The future of biosimilar use and regulation in Latin America posted 02/09/2014

There is a growing uptake of biosimilars in Latin America, but this has not been accompanied by an increase in pharmacovigila...

ECCO survey highlights lack of confidence in biosimilar mAbs posted 29/08/2014

In a presentation at the EuropaBio and the Alliance for Safe Biologic Medicines (ASBM) roundtable on naming, transparency and...

Biosimilars in the treatment of chemotherapy-induced anaemia posted 29/08/2014

A study of the use of epoetin biosimilars in the therapeutic management of anaemia secondary to chemotherapy in haematology a...

 

General

FDA debuts purple book for biologicals and interchangeable biosimilars posted 12/09/2014

On 9 September 2014, the US Food and Drug Administration (FDA) announced the publication of its first-ever edition of the ‘Pu...

US senators call for guidance on biosimilars posted 12/09/2014

A growing number of US senators are calling on the country’s Department of Health and Human Services (HHS) and Food and Drug...

Physicians believe biosimilars should have different names posted 12/09/2014

In the ongoing debate over how to name biosimilars, US physicians have now added their opinion to the discussion.

WHO proposal offers clarity for biosimilar nomenclature posted 12/09/2014

Following requests from drug regulatory authorities worldwide, the World Health Organization (WHO) has released a draft Biolo...

Biosimilars of cetuximab posted 12/09/2014

Cetuximab is a chimeric (mouse/human) monoclonal antibody. It inhibits epidermal growth factor receptor (EGFR) and is used to...

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