Biosimilars

Merck and Samsung Bioepis collaborate on biosimilar insulin

Biosimilars/News | Posted 28/02/2014

US pharma giant Merck and Korean electronics giant Samsung’s specialized biologicals unit, Samsung Bioepis, announced on 10 February 2014 that they had expanded their collaboration with an agreement to develop, manufacture and commercialize MK-1293, a biosimilar insulin glargine candidate for the treatment of patients with type 1 and type 2 diabetes.

Alvogen launches infliximab biosimilar in Europe

Biosimilars/News | Posted 21/02/2014

US generics company Alvogen announced on 13 February 2014 that it had launched the infliximab biosimilar Inflectra in Central and Eastern Europe in collaboration with Hospira.

Guiding principles for biosimilars development

Biosimilars/Research | Posted 21/02/2014

In contrast to chemically synthesized small-molecule drugs, biologicals have complex structures of high molecular weight. Therefore, even small changes in the production processes may lead to differences in the final product. The manufacturers of the originator product are not required to disclose their manufacturing process after the patent expiry. This gap in knowledge increases the probability of introducing changes in the manufacturing process of biosimilars, making producing an identical copy of a biological virtually impossible. Indeed, even different batches of the same originator biological may show a certain level of heterogeneity.

Biosimilars approved in Australia

Biosimilars/General | Posted 21/02/2014

Last update: 6 May 2025

In Australia, the legal framework for approving medicines was established via the Therapeutic Goods Act 1989.

Use of formularies could increase use of biosimilars

Biosimilars/Research | Posted 14/02/2014

Whether or not the US Food and Drug Administration (FDA) permits automatic substitution of biosimilars, healthcare systems can still consider using formularies as a way to increase the use of more affordable biosimilars [1].

Roche wins case against Herceptin ‘similar biologics’ producers

Biosimilars/News | Posted 14/02/2014

Generic drugmaker Mylan and its partner Biocon have been successfully sued by Roche for failing to carry out sufficient clinical trials on ‘similar biologics’ of the breast cancer blockbuster Herceptin (trastuzumab). Mylan and Biocon had recently announced plans to launch their ‘similar biologics’ in India [1, 2].

Teva gains FDA approval for three-times-a-week Copaxone

Biosimilars/News | Posted 14/02/2014

Teva Pharmaceutical Industries (Teva) announced on 28 January 2013 the generics giant had gained US Food and Drug Administration (FDA) for a new formulation of its blockbuster multiple sclerosis drug Copaxone (glatiramer acetate).

EMA approves follitropin alfa biosimilar

Biosimilars/News | Posted 14/02/2014

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced on 23 January 2014 that it had recommended the granting of a marketing authorization for biosimilar infertility treatment Bemfola (follitropin alfa).

The case for improving biosimilar regulatory frameworks worldwide

Biosimilars/Research | Posted 07/02/2014

In developing countries, where the cost benefits of biosimilar drugs would have the greatest impact, the financial investment needed to develop biosimilars renders them inaccessible. The situation requires increased input from international evaluation frameworks, such as those of the World Health Organization (WHO); write Barbara Milani and Sara Gaspani of Médecins Sans Frontières, Geneva, Switzerland [1].

Mylan launches trastuzumab ‘similar biologic’ in India

Biosimilars/News | Posted 07/02/2014

Generics giant Mylan announced on 3 February 2014 that its subsidiary, Mylan Pharmaceuticals Private Limited, had launched its trastuzumab ‘similar biologic’ Hertraz to the Indian market.