Biosimilars

Safety study for subcutaneous epoetin alfa biosimilar Binocrit/Epoetin alfa Hexal/Abseamed suspended

Biosimilars/News | Posted 07/10/2009

In June 2009, Sandoz, the generic pharmaceuticals division of Novartis, and its subsidiary Hexal, temporarily had to suspend continuation of their clinical study into the safety of subcutaneous application of the epoetin alfa follow-on product HX575 recombinant human erythropoietin alfa for patients with renal anaemia.

Quality, safety and efficacy of the epoetin alfa biosimilar Binocrit compared to Erypo/Eprex

Biosimilars/Research | Posted 13/10/2009

A detailed checklist on the quality, safety and efficacy assessment of biopharmaceuticals was published by Professors Irene Krämer, Roger Tredree and Arnold Vulto in the 2008 EJHP Practice article Points to consider in the evaluation of biopharmaceuticals (Eur J Hosp Pharm Prac. 2008;14(1):73-6). The checklist was then used by Dr Carsten Brockmeyer and Dr Andreas Seidl of Sandoz/Hexal for Binocrit, the results of which were published in Eur J Hosp Pharm Prac. 2009;15(2):34-40.

Protalix plant-produced Enbrel biosimilar effective in preclinical models

Biosimilars/News | Posted 22/10/2009

Protalix Biotherapeutics reported preclinical data on pr-antiTNF, a biosimilar version of etanercept (Enbrel). Produced using the company's proprietary ProCellEx technology, pr-antiTNF is a plant cell–expressed recombinant fusion protein made from the soluble form of the human TNF receptor (TNFR), fused to the Fc component of a human antibody IgG1 domain. Pr-antiTNF has an identical amino acid sequence to Enbrel. In vitro and preclinical animal studies have demonstrated that pr-antiTNF exhibits similar activity to Enbrel. Specifically, pr-antiTNF binds TNF-alpha thereby inhibiting it from binding to cellular surface TNF receptors and protects L929 cells from TNF-induced apoptosis in a dose-dependent manner. In a proof-of-concept in vivo study using an established arthritis animal model, pr-antiTNF administered intraperitoneally significantly improved the clinical arthritis parameters associated with this accepted arthritis mouse model, including joint inflammation, swelling and tissue degradation. Data from the collagen-induced arthritis animal model studies are expected to be presented at an upcoming scientific conference.

US Senate Finance Committee accepts biosimilars reimbursement measure

Biosimilars/News | Posted 22/10/2009

The US Senate Finance Committee rejected efforts by Republican lawmakers to delay a vote on the healthcare overhaul bill until it has been revised into legal language and analysed by budget experts. The Committee, however, agreed to an amendment that would give 6% higher reimbursement for doctors who prescribe follow-on biologics.

Hospira acquires biosimilar filgrastim rights and facility from Teva

Biosimilars/News | Posted 27/10/2009

Hospira announced on 30 September 2009 the acquisition of worldwide rights to a biosimilar version of filgrastim and an affiliated European manufacturing facility from PLIVA Hrvatska (in Zagreb, Croatia, now owned by Teva), a move that will help extend Hospira's reach and vertical integration in biosimilars.

US Congress urged to create a ‘real’ biosimilars pathway

Biosimilars/News | Posted 27/10/2009

On 30 September 2009, US campaigners urged US Congress to create a ‘real’ regulatory pathway for biosimilars, but researchers warn that it may take until 2011 to implement any such policies.

Biologicals and biosimilars: how can we afford them?

Biosimilars/Research | Posted 28/10/2009

Demand for biological drugs is putting pressure on health budgets. Medical student, Mr Christopher Kelly and Consultant Physician, Dr Fraz Mir of the University of Cambridge, UK, examine in the British Medical Journal of 19 September 2009 why they are so expensive and what can be done to increase access.

ACRO wants clinical trials or tests for most biosimilars

Biosimilars/News | Posted 12/11/2009

On 14 October 2009, the Association of Clinical Research Organizations (ACRO) made recommendations for biosimilars legislation in a letter sent to the US Senate Committee on Health, Education Labor and Pensions, Senate Committee on Finance, House Committee on Energy and Commerce, House Committee on Ways and Means, and House Committee on Education and Labor.

Merck & Co uses its traditional strengths in biosimilars race

Biosimilars/News | Posted 16/11/2009

With sales growth for biologicals expected to outpace that in the overall pharmaceutical sector over the next few years, it is not surprising that ‘big pharma’ has been beefing up its presence in the sector through acquisitions and licensing deals.

Mycenax to start phase III etanercept biosimilar trial

Biosimilars/News | Posted 17/11/2009

Protein drug development company Mycenax Biotech of Taiwan announced on 20 October 2009 that its rheumatoid arthritis and psoriasis drug TuNEX, a biosimilar version of etanercept, has successfully completed a phase I trial in South Korea and a phase I/II clinical trial in Taiwan is in the data analysis and report preparation stage; important clinical trial milestones towards the commercial release of the drug in both regional and global markets.