Biosimilars

FDA accepts applications for three-times-weekly follow-on Copaxone

Biosimilars/News | Posted 05/09/2014

The US Food and Drug Administration (FDA) has accepted applications submitted by generics makers Dr Reddy’s, Sandoz (Momenta Pharmaceuticals’ development and commercialization partner), and Mylan for three-times-weekly follow-on versions of blockbuster multiple sclerosis drug Copaxone (glatiramer acetate).

Infliximab biosimilar to be distributed by Mundipharma

Biosimilars/News | Posted 05/09/2014

Celltrion’s infliximab biosimilar Remsima will be distributed in Belgium, Germany, Italy, Luxembourg, The Netherlands and UK, exclusively by Mundipharma International and its independent associated companies. Remsima is a biosimilar of Johnson and Johnson (J&J) and Merck’s anti-inflammatory blockbuster Remicade (infliximab).

US senators call for guidance on biosimilars

Biosimilars/General | Posted 05/09/2014

A growing number of US senators are calling on the country’s Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) to release guidance on key scientific policy questions related to biosimilars.

The future of biosimilar use and regulation in Latin America

Biosimilars/Research | Posted 29/08/2014

There is a growing uptake of biosimilars in Latin America, but this has not been accompanied by an increase in pharmacovigilance, training or regulation. To address this, an expert panel was put together to discuss the issues involved. The panel’s perspectives on the current status led to six major recommendations drawn up to enhance the safe use of biosimilars across the region [1].

Physicians believe biosimilars should have different names

Biosimilars/General | Posted 29/08/2014

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

FDA receives application for monoclonal antibody biosimilar

Biosimilars/News | Posted 29/08/2014

South Korean biotechnology company Celltrion announced on 11 August 2014 that the company had, on 8 August 2014, completed the filing procedure to obtain US Food and Drug Administration (FDA) approval for its infliximab biosimilar.

FDA grants tentative approval for insulin treatment

Biosimilars/News | Posted 22/08/2014

On 18 August 2014, the US Food and Drug Administration (FDA) granted tentative approval for a new insulin glargine product (LY2963016).

ECCO survey highlights lack of confidence in biosimilar mAbs

Biosimilars/Research | Posted 22/08/2014

In a presentation at the EuropaBio and the Alliance for Safe Biologic Medicines (ASBM) roundtable on naming, transparency and traceability for biosimilars [1], held on 18 March 2014 in Brussels, Belgium, Dr Alessandro Armuzzi presented results of a survey of European Crohn’s and Colitis Organisation (ECCO) members [2]. The results of the survey highlight the lack of confidence ECCO members have in biosimilars and the need for continued education.

More biosimilars collaborations on the cards

Biosimilars/News | Posted 22/08/2014

Collaborations for biosimilars are still in vogue, with the latest companies making deals being PlantForm Corporation (PlantForm) with PharmaPraxis and Oncobiologics and Laboratorios Liomont.

WHO proposal offers clarity for biosimilar nomenclature

Biosimilars/General | Posted 14/08/2014

Following requests from drug regulatory authorities worldwide, the World Health Organization (WHO) has released a draft Biological Qualifier (BQ) proposal on which to base a globally recognized naming scheme for biological products, including biosimilars. According to the proposal, a four-letter code – the BQ – would be added after the INN.