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Korean biopharma gets support for biosimilars/biobetters

Biosimilars/News | Posted 18/02/2010

As reported by Narayan Kulkami, Singapore, in BioSpectrum Asia Edition on 18 January 2010, the [South] Korean biopharmaceutical industry continues to get the attention of the global players, mainly because the Korean government in 2009 identified ‘biopharmaceutical and medical equipment’ as one of the future engines for economic growth. The life sciences industry in Korea consists of close to 2000 companies including 580 pharmaceutical companies and 600 biotech companies. (see also Korean biopharma: special programme for biosimilars)

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ADCC enhancement technologies for monoclonal antibodies

Biosimilars/Research | Posted 17/02/2010

In a 2009 article by Dr Cheng Liu, founder and CEO of Eureka Therapeutics in California, and Andreia Lee in Trends in Bio/Pharmaceutical Industry on Antibody Therapeutics, it is stated that ADCC (Antibody Dependent Cell-mediated Cytotoxicity) enhancement is a key strategy for improving therapeutic antibody drug efficacy against cell-surface targets in cancer and chronic inflammation. It takes advantage of patients’ innate immune cells to kill target cells. The functions are primarily triggered through direct interaction of the Fc domain of human immunoglobulin (in most cases IgG1) with the corresponding receptors. Therapeutic antibodies with enhanced ADCC are anticipated to have a clinical advantage owing to increased specific lysis of target cells, such as cancer cells, mediated by Fc receptors present on natural killer cells, macrophages, and other immune cell types.

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Biosimilar EPO and infliximab, adalimumab get formal Japanese approval

Biosimilars/News | Posted 17/02/2010

As reported by Scrip on 21 January 2010, a large batch of new products has received final approval from Japan's ministry of health, labour and welfare, including a biosimilar erythropoietin. These and the other products given formal approval by the ministry received positive recommendations in November and December 2009.

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Xencor: Via Fc engineering enhanced antibody half-life improves in vivo activity

Biosimilars/Research | Posted 17/02/2010

Improved affinity for the neonatal Fc receptor (FcRn) is known to extend antibody half-life in vivo. However, this has never been linked with enhanced therapeutic efficacy. Mr Jonathan Zalevsky and Dr John Desjarlais et al. of Xencor at Monrovia, CA, USA, studied if such enhanced antibody half-life improves in vivo activity, as published online in Nature Biotechnology on 17 January 2010.

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Medarex: With CDA1, CDB1 MAbs better metronidazole or vancomycin treatment against C difficile toxins

Biosimilars/News | Posted 16/02/2010

New therapies are needed to manage the increasing incidence, severity, and high rate of recurrence of Clostridium difficile infection in which toxins A and B cause pseudomembranous colitis. This is associated with bleeding and a severe form of diarrhoea, which together can lead to perforation of the lower bowel and even death.

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Ustekinumab better than etanercept in psoriasis trial

Biosimilars/Research | Posted 05/02/2010

In a study by Christopher Griffiths et al. of the University of Manchester, UK, Johnson & Johnson (J&J)’s monoclonal antibody STELARA (ustekinumab, an interleukin-12 and interleukin-23 blocker) and Amgen’s Enbrel (etanercept, an inhibitor of tumour necrosis factor: anti-TNF) have been compared for the treatment of psoriasis, as published in The New England Journal of Medicine (NEJM) of 14 January 2010. The Phase 3, Multicenter, Randomized Study Comparing CNTO 1275 and Etanercept for the Treatment of Moderate to Severe Plaque Psoriasis’ was sponsored by J&J’s Centocor.

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Innovation over imitation: New FOBs technologies, players

Biosimilars/General | Posted 03/02/2010

In an article by Xencor President and CEO Bassil Dahiyat, published in Pharmaceutical Executive on 4 November 2009, tables are presented on new technologies for creating ‘biobetter’ follow-on biologics (FOBs) and potential ‘Big Pharma’ players in FOBs.

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Innovation over imitation - How to deliver FOBs on the bottom line

Biosimilars/General | Posted 03/02/2010

In an article by Xencor President and CEO Bassil Dahiyat, published in Pharmaceutical Executive on 4 November 2009, the development of ‘biobetter’ follow-on biologics (FOBs) — optimised versions of pioneer drugs that have improved pharmaceutical properties but carry only minor changes in structure — is discussed.

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Innovation over imitation - Charting the FOBs landscape

Biosimilars/General | Posted 03/02/2010

In an article by Xencor President and CEO Bassil Dahiyat, published in Pharmaceutical Executive on 4 November 2009, the development of ‘biobetter’ follow-on biologics (FOBs) — optimised versions of pioneer drugs that have improved pharmaceutical properties but carry only minor changes in structure — is discussed.

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Innovation over imitation: Tools to compete and win with ‘biobetter’ FOBs

Biosimilars/General | Posted 03/02/2010

In an article by Xencor President and CEO Bassil Dahiyat, published in Pharmaceutical Executive on 4 November 2009, the development of ‘biobetter’ follow-on biologics (FOBs) — optimised versions of pioneer drugs that have improved pharmaceutical properties but carry only minor changes in structure — is discussed.