Biosimilars

Cipla enters the biosimilars market

Biosimilars/News | Posted 02/07/2010

India-based generics’ manufacturer Cipla is paying US$65 million to buy a significant minority stake in two Asian biotech companies with plans to develop a range of discounted biosimilars, generic substitutable versions of branded biologic drugs. Cipla's Chairman says he specifically wants to create follow-on therapies to three of Roche's top biologics – Avastin, Enbrel and Herceptin – that account annually for US$19 billion in sales.

Hospira’s biosimilar filgrastim product Nivestim approved

Biosimilars/News | Posted 25/06/2010

On 10 June 2010, Hospira received approval from the European Commission for its biosimilar filgrastim product, Nivestim, for the prevention of febrile neutropenia and reduction in duration of chemotherapy-induced neutropenia.

Phase III study of a new biosimilar filgrastim product (Zarzio) published

Biosimilars/Research | Posted 04/06/2010

A biosimilar recombinant human granulocyte colony-stimulating factor (filgrastim) (rhG-CSF), Zarzio (Sandoz GmbH), was evaluated in healthy volunteers in four phase I studies and in neutropenic patients in a phase III study.

Phase I studies of a new biosimilar filgrastim product (Zarzio) published

Biosimilars/Research | Posted 04/06/2010

Zarzio (Sandoz GmbH), a biosimilar recombinant human granulocyte colony-stimulating factor (filgrastim), was evaluated in healthy volunteers in four phase I studies and in neutropenic patients in a phase III study.

Development of a new biosimilar filgrastim product (Zarzio)

Biosimilars/News | Posted 04/06/2010

Filgrastim, a growth factor, is used to aid the recovery of bone marrow after chemotherapy treatment for cancer, especially in patients with neutropenia (low white blood cell count in the blood), causing reduced host defence.

Include health economics in development of biosimilars

Biosimilars/Research | Posted 15/04/2010

The early inclusion of health economics in the process of developing biopharmaceuticals and biosimilars is imperative with a view to demonstrating their relative (cost) effectiveness and informing registration, pricing and reimbursement decisions, writes Professor Steven Simoens of the Katholieke Universiteit Leuven, Belgium, in the Journal of Medical Economics in 2009.

In the article he discusses health economic challenges of research and development, registration, pricing and reimbursement of biopharmaceuticals and biosimilars. Professor Simoens identified relevant studies by searching PubMed, Centre for Reviews and Dissemination databases (Database of Abstracts of Reviews of Effects, National Health Service Economic Evaluation Database, and Health Technology Assessments Database), Cochrane Database of Systematic Reviews and EconLit up to March 2009. Additionally, the bibliography of included studies was checked for other relevant studies.

Health Canada issues finalised guidance on biosimilars

Biosimilars/News | Posted 13/04/2010

Health Canada has released the finalised version of its Guidance Document on the approval of Subsequent Entry Biologics (SEBs), which is effective as of 5 March 2010.

Global Industry Analysts: Global biosimilars market to exceed US$2 billion by 2015

Biosimilars/General | Posted 09/04/2010

On 24 March 2010, Global Industry Analysts (GIA) announced the release of a new report, entitled ‘Biosimilars: A Global Strategic Business Report’

Biosimilars mean competition for biologic brands

Biosimilars/General | Posted 09/04/2010

The historic passage of two US healthcare reform bills on 21 March 2010, including a US Senate bill with an approval pathway for biosimilars, means biologic brands could see rivals replicate and market similar products, writes Mr Marc Iskowitz in Medical Marketing & Media. According to him, the new legislation, signed by US president Mr Barack Obama on 23 March 2010, lays out a series of requirements for the FDA to consider follow-on biologics (FOBs) applications.

Ranbaxy to develop biosimilars with US-based Pfenex

Biosimilars/News | Posted 06/04/2010

On 29 March 2010, Daiichi Sankyo’s Ranbaxy Laboratories in India announced its collaboration with US-based Pfenex on the development of an undisclosed biosimilar therapeutic protein with the Pfenex Expression Technology platform, a Pseudomonas-based recombinant protein expression technology.