Biosimilars

Intas launches rituximab ‘similar biologic’ in India

Biosimilars/News | Posted 10/05/2013

India-based generics company Intas Pharmaceuticals (Intas) announced the launch of a ‘similar biologic’ – as the Indian regulatory authorities call these products –version of rituximab in India.

Development of biosimilars for rheumatology

Biosimilars/Research | Posted 03/05/2013

In 2012, worldwide sales for the top three selling tumour necrosis factor (TNF) inhibitors reached US$20 billion. These biological treatments for arthritis are costing patients between US$10,000–US$30,000 per year making the need for lower cost biosimilars clear [1].

Sandoz applies for Japanese approval for biosimilar G-CSF

Biosimilars/News | Posted 03/05/2013

Novartis generics unit Sandoz announced on 25 April 2013 that it has filed an application with the Japanese health authority – Pharmaceuticals and Medical Devices Agency (PMDA) – for marketing authorization of EP2006, a biosimilar version of recombinant human granulocyte colony-stimulating factor (G-CSF).

Biosimilars agreements for Hospira and mAbxience

Biosimilars/News | Posted 03/05/2013

In line with Hospira’s strategy of expansion into biosimilars, the injectable generics specialist announced on 29 April 2013 that it had entered into a collaborative arrangement for several biosimilar products with NovaQuest Co-Investment Fund I, L.P. (NovaQuest).

Hospira marks five years of biosimilars

Biosimilars/News | Posted 29/04/2013

Self-proclaimed world leader in injectable drugs, Hospira, commemorated five years of providing biosimilars to the European market at the BIO International Convention in Chicago, USA, on 24 April 2013.

Celltrion stops phase III trial of biosimilar rituximab

Biosimilars/News | Posted 29/04/2013

South Korean biotechnology company Celltrion has stopped the late-stage trial of its biosimilar version of Roche’s blockbuster arthritis/non-Hodgkin’s lymphoma drug MabThera/Rituxan (rituximab).

Efficacy, Extrapolation, Interchangeability V16E25LB

Efficacy, extrapolation and interchangeability of biosimilars

Biosimilars/Research | Posted 19/04/2013

Biosimilars have been available in Europe for more than seven years; despite this fact, physicians still have concerns about the use of biosimilars. Some of their concerns have been discussed by members and experts of the Working Party on Similar Biologic Medicinal Products of the European Medicines Agency (EMA) [1].

Cipla launches first etanercept ‘similar biologic’ in India

Biosimilars/News | Posted 19/04/2013

India-based generics manufacturer Cipla announced on 17 April 2013 the launch of its ‘similar biologic’ product Etacept, the first ‘similar biologic’ of etanercept in India.

Research on clinical trial issues for biosimilars

Biosimilars/Research | Posted 19/04/2013

Period: September to December 2012

In order to demonstrate comparability between a biosimilar and its reference product, EMA recommends that the clinical trial should make it possible to detect a difference between the biosimilar and reference product. In most cases, this means that a two-arm clinical trial design (reference biological and biosimilar) in a small group of homogenous patients may be used. If the two arms of the trial produce similar results, then the biosimilar can be approved.

Quality, similarity and safety of biosimilars

Biosimilars/Research | Posted 12/04/2013

An abbreviated pathway for the approval of biosimilars was implemented in the EU in 2005. Despite biosimilars being available in Europe for more than seven years, physicians still have concerns about the use of biosimilars. Members and experts of the Working Party on Similar Biologic Medicinal Products of the European Medicines Agency (EMA) highlight what physicians need to know to make informed and appropriate treatment choices for their patients [1].