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Information @ a Glance

General
  • The term "biogeneric" can simply be defined as a pharmaceutical preparation based on a biologically active substance. This is in contrast to traditional, multisource, generic pharmaceuticals.
  • A biogeneric is defined as the generic alternative of a biopharmaceutical or biologic, which is a copy of the original product.
  • Apart from the European and US regulatory developments, first biogeneric R&D activities are reported in Japan (EPO), but the regulatory situation is not yet transparent. Biogeneric development activities so far focus on copycats of first generation protein products, but in the case of hGH slow release versions of biogeneric hGH are in advanced clinical development in EU and US territories. Indian companies are already working on pegylated versions of biogeneric proteins and also started with development of biogeneric antibodies (rituximab).

Processing

  • The major therapeutic proteins are not only being challenged by biogeneric developments in the Western countries, but also by innovative investigational new drugs. A state of the art approach is pegylation or glycopegylation of the parent protein, but protein engineering technologies may lead to the same effect of a longer half-life and also result in improved pharmacodynamic properties.
  • The Competitor Analysis provides a stakeholder evaluation in the US$ 42 bln markets of 10 major proteins

Market

  • The total biopharmaceutical market is valued at US $ 18,000 million with the US accounting for the largest proportion, 45%, followed by Europe, 30%, Japan, 20%, and the rest of the world, 5%. Assuming a similar penetration rate for biogenerics as for traditional drugs , then the potential market for biogenerics would be estimated at US$ 2,000 million.
  • Globally, the generic pharmaceutical business generated approximately $33 billion in revenue in 2002 . The financial success of the generic pharmaceutical industry has led many industry thought leaders and company executives to consider developing and manufacturing generic versions of blockbuster biopharmaceuticals near patent expiry such as Epogen (erythropoietin-alpha, EPO),Neupogen, (granulocyte colony stimulating factor, G-CSF), and Avonex (interferon-beta).
  • At present, India is one of the major contributors in the world biogeneric market along with China. The entry of Indian firms, with their own brands of recombinant products, has changed the dynamics of the domestic biogenerics market.
  • With low capital and operational cost in the area of bio-manufacturing, industry estimates that the market for biogenerics in India is expected to see a 43 percent jump from Rs 308.50 crore in 2001 to Rs 1,305.7 crore in 2005 and projected to reach Rs 1,864.3 crore by 2007 registering a growth of 19 percent.
  • The main players in Biogenerics market are Sandoz, Cangene, LG Chemicals, Rhein Biotech, PCGen, Wockhardt, Microbix, GeneMedix, Stada, DSM Biologicals, and Amgen.

Policies & Report

  • Some policies focused on subsidising research and development and not on making the types of structural and regulatory
    changes that would support the sustainability of a sustainable Australian generic pharmaceutical industry linked by incentives to nano/biotechology companies and increased science education infrastructure.
  • The report will inform the reader about the key obstacles that stand in the way of a smooth transition from biopharmaceutical manufacture to biogenerics. The most complex stumbling block is the availability of bulk active biopharmaceuticals through non-patent-infringing routes. Biogenerics makers will be particularly challenged by patent
    coverage for biopharmaceuticals and also affordable demonstration of bioequivalence, both of which have been obstacles
    to market development.

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