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Patent perspective At cod consultation doctor fee free hydrocodone the time of writing, reliable statistics on the patenting of biologic drugs were not available. The Panel was advised by IP Australia that this was due to the difficulty in differentiating between patents for small molecule drugs and biologics without examining each individual patent.

Marimuthu et al conducted a study which examined the patent landscape for biologics based on information available from the hydrocodone recommended dosage product labels.355 The study found that of the 44 FDA approved biologics examined, a total of 151 relevant patents existed.356 This suggests that the patent landscape for biologics is no more complex than that for small molecule drugs. The availability of patents for biological materials and for many of the research tools buy cheap buy vicodin without prescription used in early stage research and development in biomedicine has raised concerns about a so-called anti-commons effect, which could slow the pace of biologic drug development.357 This is where a large number of intellectual property rights owned by different parties relate to a single product, making it difficult for any one party to make the product.

As discussed in the previous paragraph, there is no evidence that this is occurring for biologics more so than for other drugs. There is also no clear evidence that the pace of development has in fact been slowed by early-stage patents.358 9.2.5. The generic buy cheap buy vicodin without prescription industry and biosimilars The development of biosimilars poses challenges for the generic manufacturing crhc uiuc edu credit incoming buy tramadol sector when compared with small molecule drugs.

Biosimilars are complex and achieving therapeutic equivalence is extremely difficult. The clinical performance of biologics is highly dependent on the method of production and purification.359 Even minor differences in the atmosphere or manufacturing process can compromise activity.360 Another concern is that of immunogenicity. Immunogenicity refers to the ability of a biological medicine to be considered foreign by the human body and generate an immune response such buy cheap buy vicodin without prescription as neutralising antibodies.361 Due to the complex nature of biologics, obtaining regulatory approval for biosimilars is more complicated than that of generic small molecule drugs. A biosimilar drug is not considered to be bioequivalent to an originator reference product by the TGA. As a consequence, a generic company cannot rely wholly on the clinical and safety data of the reference product and must produce its own data to ensure that a biosimilar can be used in the same manner as the reference product. Alphapharm provided evidence in public hearing which outlined these difficulties. Alphapharm stated that manufacturing of biosimilars would require a specialised facility and it would be difficult to manufacture on buy cheap buy vicodin without prescription a large scale.

Manufacturing was complicated by the highly sensitive nature of biologics and the high risk of contamination. The additional costs that generic companies would incur by having to undertake info may personal phentermine remember style use clinical trials to demonstrate safety and efficacy was also raised. Despite these difficulties, Hospira has been successful in obtaining regulatory approval and PBS listing for its biosimilar of the drug filgrastim, marketed as Nivestim. Regulatory Approval of the Biosimilar - Nivestim (filgrastim) Filgrastim is a granulyte colony-stimulating factor produced using gene technology. It is used to treat neutropenia, a condition in which infection-fighting white blood cells become too low. Neutropenia often occurs as a result of chemotherapy. The reference product for filgrastim was the subject of Australian Patent No. Amgen marketed filgrastim under the brand name Neupogen. Neupogen was estimated to have sales of $25m AUD in 20 1 0.362 Hospira applied for TGA approval via the biosimilar pathway and was granted ARTG listing for Nivestim on 16 September 2010.

As a result, filgrastim buy cheap buy vicodin without prescription was subject to a statutory price reduction and moved to the F2 formulary on the PBS. Regulatory environment The TGA introduced the Biologicals Regulatory Framework and the Australian Regulatory Guidelines for Biologicals (ARGB) in 2011.

The purpose of the Framework is to regulate human cell and tissue-based products. The Framework provides a system of assessment and controls that must be completed before biological products can be marketed in Australia, as well as further controls to apply once the goods are marketed.363 The key benefits of the Framework are designed • minimise the risk of infectious disease transmission; •ensure the level of regulation is appropriate to the level of risk posed by specific biologic products by separating them into four classes; • provide a framework to deal with emerging technologies; • provide a unique framework for biological medicines as current arrangements for non-biologics may not be appropriate; • reduce ambiguity about what is included or excluded from regulation; and • increase harmonisation of therapeutic goods regulation.364 Biological products included in the framework are human tissue therapy products, processed human tissues, human cellular therapy products, immunotherapy products containing human cells, and genetically modified human cellular products, and other products which include such biologics as combination products.365 The TGA has adopted the European Medicines Agency (EMA) Guidelines for assessing biosimilars.366 These guidelines require that applicants submit comparative clinical and pharmacokinetic studies, non-clinical studies, clinical pharmacodynamic studies, toxicology studies, comparative clinical efficacy studies, and a post-marketing surveillance plan to monitor any onset of immunogenicity that may occur.367 9.2.7.



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