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Common examples of biologics are the drugs Enbrel and Humira, which are antibody-based recombinant proteins used to treat rheumatoid arthritis. In Australia, generic versions of biologics are referred to as 'Similar Biological Medicinal Products (SBMPs)', but they may also be referred to as 'biosimilars' or 'biogenerics'.344 A biosimilar is a biological is tramadol tracked product that can demonstrate a degree of similarity to a biologic product which has already received approval for registration on the ARTG.

Unlike generic versions of small molecule drugs, biosimilars are not considered to be bioequivalent to a reference biological product. This is due to the highly complex nature of biological medicinal products. The EU Guideline on Similar Biological Medicinal Products (CHMP/437/04) states that by definition: .similar biological medicinal products are not generic medicinal products, since it could be expected that there may be subtle differences between similar biological medicinal products from different manufacturers or compared with reference products, which may not be fully apparent until greater experience in their use has been established. The introduction of biosimilars into the Australian market brings significant challenges for both policy makers and generic manufacturers. Why are biologics important Biologics are an important and innovative development in hydrocodone cod no script money orders only pharmaceuticals. They have revolutionised the treatment of diseases such as anaemia, diabetes, cancer, hepatitis, and multiple sclerosis.345 The smallpox vaccine was probably the first biologic to be developed, in the late 18th century. However, commercial manufacture of biologics only hydrocodone apap 10mg 325mg tabs started in earnest in the 1980s, as recombinant DNA hydrocodone cod no script money orders only technology became widely used and the biotechnology industry emerged.

At that time, US-based companies like Genentech and Amgen first started to produce first generation therapeutic proteins such as insulin, erythropoietin and human growth hydrocodone cod no script money orders only hormone using recombinant DNA technology. The Australian biotechnology industry is involved in the development of a range of new biologics, and has experienced some success. Gardasil is a vaccine against the human papilloma virus, which causes cervical cancer.

Professor Ian Frazer at the University of Queensland made the initial discovery of a potential target for the vaccine on the coat of the virus in 1991.

Australian biotechnology company CSL, in collaboration with the multinational pharmaceutical company Merck, commercialised the technology,346 which is now protected by a hydrocodone cod no script money orders only family of patents. Market profile The US Pharmaceutical Industry Association estimates that there are 400 biologic drugs on the market and 900 others in the pipeline.347 In Australia, there are currently 64 biologics listed on the PBS.348 The use of biological medicines is set to increase in the future, with the development of targeted therapies and personalised medicine. IMS Health estimates that since the origins of biologics in the 1980s, the market has developed into one with a world-wide value of US$138 billion.349 Many high value biologic drugs are due to lose patent protection in the next five years,350 providing a significant market opportunity for the production of biosimilars. The entry of biosimilars is important for consumers, hydrocodone cod no script money orders only as it is estimated that they provide an affordable alternative to originator medicines, with a cost reduction in the region of 20-25%.351 IMS Health estimates that biosimilars will constitute 50% of the off-patent biological medicines market by 20 20.352 Despite the promise of biologics, they are more costly to develop than chemical drugs, and more prone to failure. Roth gives figures of $802 million as the average cost of developing a chemical drug and $1.2 billion as the average cost of developing a new biologic.353 The market for a biologic is also typically very different to the market for a small molecule drug. Small molecule drugs can have very large patient cohorts and be relatively inexpensive to manufacture, resulting in a low price per unit. In contrast, manufacture of biologics is more complex and expensive.354 Although some biologics have a large patient cohort, such as patients requiring insulin therapy or treatment for rheumatoid arthritis, biologics have the potential to develop targeted solutions for small patient cohorts with particular conditions.



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