Menu

Biosimilars

picture11

Korean biopharma: special programme for biosimilars

Biosimilars/News | Posted 18/02/2010

As reported by Narayan Kulkami, Singapore, in BioSpectrum Asia Edition on 18 January 2010, the Korean biopharmaceutical sector gets support for biosimilars and/or biobetters.(see also Korean biopharma gets support for biosimilars/biobetters)

picture10

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)

picture03

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.

picture19

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.

picture23

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.

picture13

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.

picture12

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.

picture21

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.

picture18

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.

picture14

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.

picture20

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.

picture08

Innovation over imitation: High-cost biosimilar FOB development, slow uptake

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.

picture05

Innovation over imitation: ‘Biobetter’ follow-on biologics

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.

picture11

FTC- Biosimilars to spur innovation and competitive prices

Biosimilars/Research | Posted 02/02/2010

In the Journal of Generic Medicines (published online 8 September 2009), Michael Wroblewski and Elizabeth Jex of the US Federal Trade Commission (FTC) write about the promise of follow-on biologics (FOBs) to spur both biological drug innovation and competitive prices.

picture18

Time for a re-evaluation of ESAs

Biosimilars/Research | Posted 01/02/2010

In an article in The New England Journal of Medicine (NEJM) by Ellis F Unger, Aliza M Thompson, Melanie J Blank, and Robert Temple, published on 6 January 2010 at NEJM.org, it is stated that it is time for a re-evaluation of erythropoiesis-stimulating agents (ESAs).

picture10

Campbell Alliance: how biotech should prepare for biosimilars

Biosimilars/News | Posted 01/02/2010

In the recently published article ‘Bracing for Biosimilars’ by Kuyler Doyle, Tony Lanzone and Fahti Khosrow-Shahi of management consultancy firm Campbell Alliance, some insight is given into what commercial and reimbursement decision makers for biotechnology companies should be doing to prepare for the arrival of biosimilars.

picture09

Modify Fc fucosylation and β-galactosylation for biobetter MAbs

Biosimilars/Research | Posted 28/01/2010

In an article by Dr Claire Morgan and Dr Daryl Fernandes of Ludger, published in IPI of Autumn 2009, it is shown how both the original drug manufacturers and the designers of follow-on biologics could produce biobetter monoclonal antibodies (MAbs) through glycoengineering. (see also Ludger’s GTO-QbD: Defining glycovariant biobetter MAbs, When is a glycoengineered biobetter commercially better than a biosimilar? and Strategy and tools for building glycoengineered biobetter MAbs)

picture25

Design out NeuGc, Fab glycosylation for biobetter MAbs

Biosimilars/Research | Posted 28/01/2010

In an article by Dr Claire Morgan and Dr Daryl Fernandes of Ludger, published in IPI of Autumn 2009, it is shown how both the original drug manufacturers and the designers of follow-on biologics could produce biobetter monoclonal antibodies (MAbs) through glycoengineering. (see also Ludger’s GTO-QbD: Defining glycovariant biobetter MAbs, When is a glycoengineered biobetter commercially better than a biosimilar? and Strategy and tools for building glycoengineered biobetter MAbs)

picture13

Design out Gal-α(1,3)-Gal for biobetter MAbs

Biosimilars/Research | Posted 28/01/2010

In an article by Dr Claire Morgan and Dr Daryl Fernandes of Ludger, published in IPI of Autumn 2009, it is shown how both the original drug manufacturers and the designers of follow-on biologics could produce biobetter monoclonal antibodies (MAbs) through glycoengineering. (see also Ludger’s GTO-QbD: Defining glycovariant biobetter MAbs, When is a glycoengineered biobetter commercially better than a biosimilar? and Strategy and tools for building glycoengineered biobetter MAbs)

picture21

Strategy and tools for building glycoengineered biobetter MAbs

Biosimilars/Research | Posted 28/01/2010

In an article by Dr Claire Morgan and Dr Daryl Fernandes of Ludger, published in IPI of Autumn 2009, it is shown how both the original drug manufacturers and the designers of follow-on biologics could produce biobetter monoclonal antibodies (MAbs) through glycoengineering. (see also Modify Fc fucosylation and β-galactosylation for biobetter MAbs, Design out NeuGc, Fab glycosylation for biobetter MAbs, Design out Gal-α(1,3)-Gal for biobetter MAbs, When is a glycoengineered biobetter commercially better than a biosimilar? and Ludger’s GTO-QbD: Defining glycovariant biobetter MAbs)