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Biosimilars/Research

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How cheap will biosimilars need to be

Biosimilars/Research | Posted 05/08/2011

What level of discounts will biosimilars need to provide to be competitive? Some believe that biosimilars will need to provide substantial discounts, being priced as low as 25%, and not 75%, of the originator price [1].

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Biosimilar regulatory issues

Biosimilars/Research | Posted 08/07/2011

In Europe, the regulatory frameworks for biosimilars are largely established, with both general guidelines and product specific guidelines put in place by the EMA, covering human insulin, somatropin, human growth hormone, erythropoietin, interferon-alpha, low molecular weight heparin and monoclonal antibody. The agency is also currently working on draft guidelines for a number of other product class specific guidelines, including interferon-beta and follicle stimulation hormone.

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Manufacturing of biosimilars

Biosimilars/Research | Posted 24/06/2011

Manufacturing of biosimilars is more challenging than the traditional small molecule generics. Some of the reasons are:

  • Investments (including operating costs) associated with manufacturing of biosimilars along with the risk of failure for biosimilars are significantly higher than that for small molecule generics. This results in a relatively smaller discount for biosimilars compared to small molecule generics.
  • Minor changes in manufacturing process can cause significant changes in efficacy or immunogenicity.
  • Biosimilars are larger and more complex molecules to manufacture.
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Opportunities for biosimilars in emerging markets

Biosimilars/Research | Posted 09/09/2011

By 2015, IMS Health expects spending on biosimilars to exceed US$2 billion annually, or about 1% of total global spending on biologicals [1]. This growth in biosimilars will be driven mainly by patent expiries coming in the next five years. However, due to the complexity and cost of developing biosimilars for western markets many biosimilar manufacturers are turning to emerging markets as being a much more cost-effective solution.

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Doctors wary of using biosimilars for extrapolated indications

Biosimilars/Research | Posted 02/09/2011

A report published on 24 August 2011 by research and advisory firm Decision Resources finds that the majority of US and European physicians are wary of using a biosimilar for an indication for which supporting clinical data are lacking.

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Controversial nomenclature for new biosimilars

Biosimilars/Research | Posted 02/09/2011

How will FDA chose to name biosimilars? The answer it appears is not simple and could greatly affect the marketing costs associated with these products [1].

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A biosimilar by any other name …

Biosimilars/Research | Posted 12/08/2011

Following the expiration of patents on the originator molecules, copied products have been introduced into the market. EU regulators have named these products as ‘biosimilars’, that is ‘similar biological medicinal products’; and US regulators refer to them as ‘follow-on biologics’. Specific regulatory pathways have also been established for these biosimilar products, which differ from those for ‘chemical generics’ [1].

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The market for biosimilars

Biosimilars/Research | Posted 29/07/2011

How do the different markets respond to biosimilars? Markets with strong generic adoption frameworks are likely to have good biosimilar adoption as well. However, physician willingness to adopt may be a barrier to entry [1].

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EMA proposes more precise definition for biosimilars

Biosimilars/Research | Posted 12/08/2011

Members of the Biosimilar Medicinal Products Working Party at the EMA expressed the need to propose a more precise definition for biosimilars due to problems arising from imprecise usage of the term biosimilar in the literature [1].

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Observations on the introduction of biosimilar epoetins into Europe

Biosimilars/Research | Posted 12/08/2011

Professor Wolfgang Jelkmann of the University of Luebeck in Germany has recently published a review article summarising the experiences with biosimilars introduced in the EU after the original biopharmaceutical patents expired [1].

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US approvals of biologicals doubled in last decade

Biosimilars/Research | Posted 10/06/2011

Regulatory approvals for new biological drugs in the US have nearly doubled in the last decade compared with the 1990s, according to the May/June 2011 issue of the Tufts Center for the Study of Drug Development (CSDD) Impact Report. However, the author of the report, Research Assistant Professor Janice Reichert, said there are still ‘substantial challenges’ to be faced by biologicals manufacturers if they wish to ‘maintain that pace’.

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Need for a global pathway for biosimilars

Biosimilars/Research | Posted 06/06/2011

The need for access to biosimilars is global, yet the regulations are national. Issues with this approach are discussed by Dr Mark McCamish and Dr Gillian Woollett in their published paper [1].

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Worldwide biosimilar development

Biosimilars/Research | Posted 29/04/2011

The limited access to high-quality biologicals due to the cost of treatment constitutes an unmet medical need in the US and other regions of the world [1].

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Opportunities for biosimilar development

Biosimilars/Research | Posted 06/05/2011

Rising drug costs and limited healthcare budgets across the world, coupled with the fact that many biotechnology drugs will soon lose their patent protection, means that there is a huge opportunity for biosimilar manufacturers.

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Comparability for biosimilar development

Biosimilars/Research | Posted 13/05/2011

How does ‘comparability’ apply to biosimilar drug development? This was the question discussed by Dr Mark McCamish and Dr Gillian Woollett [1].

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Regulatory approach to biosimilar development

Biosimilars/Research | Posted 20/05/2011

Legislation in Europe in 2004 created a legal pathway for approval of biosimilars and the first biosimilar, Omnitrope (somatropin) as approved by the EMA in 2006. The US is lagging behind somewhat, having only just approved a legal pathway in March 2010 and with practical guidance from the FDA still anticipated.

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Interchangeability or substitution of biosimilars

Biosimilars/Research | Posted 27/05/2011

The interchangeability or substitution of biosimilars is a subject that differs somewhat between Europe and the US. These different approaches to biosimilars are discussed by Dr Mark McCamish and Dr Gillian Woollett in their published paper [1].

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Changes in the quality attributes of darbepoetin alfa

Biosimilars/Research | Posted 13/05/2011

Quality changes over a period of time were found in commercially available darbepoetin alfa (Aranesp) by Sandoz researchers. Since the drug remained on the market with an unchanged label, this would indicate that the changes were accepted by the health authorities [1].

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Acceptable changes in quality for glycosylated biologicals

Biosimilars/Research | Posted 06/05/2011

Research carried out by Sandoz into three glycosylated protein biotechnology drugs currently on the market showed quality changes over the period studied. Since all three drugs remained on the market with unchanged labels, this would indicate that the changes were accepted by the health authorities [1].

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Etanercept and quality attributes changes

Biosimilars/Research | Posted 27/05/2011

Quality changes in commercially available etanercept (Enbrel) were found by Sandoz researchers over a period of time. Since the drug remained on the market with an unchanged label, this would indicate that the changes were accepted by the health authorities [1].