Biogenerics 2005: An Emerging Global Market?DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/reports/c24720) has announced the addition of Biogenerics 2005: An Emerging Global Market? to their offering There are potentially big rewards for companies who can overcome the regulatory, legal and technical obstacles related to biogenerics. But there are dangers too - that is why this critical, analysis is essential reading. Biological drugs account for 10-15% of the world pharmaceutical market. This is equal to around US$30 billion in the USA alone. The biologicals Biologicals Biological products used to induce immunity to various infectious diseases or noxious substances of biological origin. The term is usually limited to immune serums, antitoxins, vaccines, and toxoids that have the effect of providing protective sector is outperforming the pharmaceutical industry as a whole, growing at double the pace in some cases. But the development of the biogenerics sector will only come after some significant problems have been tackled. Consider... - Biologic drugs are expensive and increasingly widely-used. For chemical drugs, generic versions of off-patent products have helped to reduce pharmacy pharmacy, art of compounding and dispensing drugs and medication. The term is also applied to an establishment used for such purposes. Until modern times medication was prepared and dispensed by the physician himself. In the 18th cent. bills and increase funding for new products. It would seem obvious, therefore, for companies to develop generic versions of the older biologic drugs, and for health payers to welcome them. But achieving this has proved far from straightforward. - Early market entry in the USA is not a practical proposition. The nature of the current regulatory system precludes approval in most cases. The FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. has yet to issue detailed guidance on the topic, although this is planned for 2005. Only then can Congress begin the legislative process. Given the time this will probably take, biogenerics are unlikely to appear on the US market until at least 2010. - The European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community is some years ahead of the USA, on paper at least. The 2003 EU regulatory reforms Regulatory Reform concerns improvements to the quality of government regulation. At the international level, the "OECD Regulatory Reform Programme is aimed at helping governments improve regulatory quality -- that is, reforming regulations that raise unnecessary obstacles to make specific provision for biogenerics, and the EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. has issued guidance documents on most of the major products. No product has yet been approved in the EU, however, with a number of companies still preparing regulatory submissions. Market entry in two to three years is a realistic prospect. This key report answers the important questions For everyone involved in this emerging market sector Biogenerics 2005: An Emerging Global Market? is essential reading. Thoroughly researched and including the very latest information, the report distils and analyses the key issues in more than 100 thought-provoking pages: - What are the regulatory hurdles to be overcome? - How might the political environment affect development? - How might companies overcome technical issues related to, for example, bioequivalence bioequivalence /bio·equiv·a·lence/ (-e-kwiv´ah-lens) the relationship between two preparations of the same drug in the same dosage form that have a similar bioavailability. ? - US/Europe regulation: USA in the slow lane but for how long? - What products have recently been approved and which are under consideration? - Where are the best opportunities? - The commercial/competitive cost of biogenerics: when is it worth it? Company Profiles: - Anhui Anke Biotech bi·o·tech n. Informal Biotechnology. biotech Noun short for biotechnology Noun 1. - Biocon - BioGeneriX - BioPartners - Cangene - CIGB CIGB Commission Internationale des Grands Barrages (French: International Commission on Large Dams) (Cuba) - Cipla - CheilJedang (CJ Corp) - Dr Reddy's - Dragon dragon, mythical beast usually represented as a huge, winged, fire-breathing reptile. For centuries the dragon has been prominent in the folklore of many peoples; thus, its physical characteristics vary greatly and include combinations of numerous animals. Pharmaceuticals- GeneMedix - Inno Biologics - LG Life Sciences - Microbix - Momenta Pharmaceuticals - Pliva - Sandoz - Savient Pharmaceuticals - Shenyang Sunshine Pharmaceutical Co Ltd. - Teva Pharmaceuticals - Wockhardt For more information visit http://www.researchandmarkets.com/reports/c24720 |
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