Biogenerics

Castro CE, NO Belser (1990) Biodehalogenation oxidative and reductive metabolism of 1,1,2-trichloroethane by Pseudomonas putida—biogeneration of vinyl chloride. Environ Toxicol Chem 9 707-714. 

Immobilized enzymes, 3 670 10 270-272 industrial-scale apphcations of, 10 272 silylating agents and, 22 700—701 Immobilized glucose oxidase, hydrogen peroxide biogeneration for bleaching, 4 65-66... 

Thus, arguments abound as to what would constitute similarity in these protein drugs to claim them as biogenerics, considering that these proteins have thousands of atoms with molecular weight often in excess of 40kDa with complex constructs, compared to small molecules of nominally less than 0.5 kDa with relatively simple structures. 

TABLE 103 Biologies Products Facing Biogenerics Challenge... 

The FDA stressed its commitment to review case-specific biogenerics by considering the following ... 

It is conceivable that, in the not too distant future, biogenerics will be approved with applicants supplying certain preclinical data and clinical trial information to prove comparability and bioequivalence. At the same time, the regulatory authorities will rely on their experience and expertise in approving innovator biologies to guide them as they evaluate biogenerics. 

Explain what is meant by biogenerics and the regulatory status with respect to approving these drugs. 

Refer to Section 10.7. The industry consensus is that biogenerics will be a reality in the near future, resulting from improvements in technology, which would be able to provide more precise characterization of proteins, and the continued pressure to drive down rising healthcare costs. 

Kajiwara T, Matsui K, Akakabe Y (1996) Biogeneration of flavor compounds via edible seaweeds. In Takeoka GR, Teranishi R, Williams PJ, Kobayashi A (eds) Biotechnology for improved foods and flavours. ACS symposium series 637. American Chemical Society, Washington, D. C., p 146... 

Ctoteau R, Biosynthesis of cychc monoterpenes, in PatlimentTH, Croteau R (eds.). Biogeneration of Aromas, ACS Symposium series 317, Washington DC, USApp. 13 156, 1986. 

Within the 120 billion worth of proprietary drugs that face patent expiry, there is also 20 billion worth of biopharmaceuticals (e.g., epoetin and insulin). Biogenerics produced in living celllines have not played a role so far, mainly because an unambiguous regulatory framework has not been established yet in the United States. 

In general, alcohols, such as methanol, ethanol, propanol, butanol, amyl alcohol, etc., can be used with acid-catalyzed transesterifications to obtain high biodiesel yields. " Methanol is preferred due to its low cost and wide availability, but bioderived ethanol would be ideal for the synthesis of a fully biogenerated fuel. On the other hand, the use of heavier alcohols like butanol... 

Mclver RC, Reineccius GA (1986) In Parliment TH, Croteau R (eds) Biogeneration of aromas. ACS symposium series 317. American Chemical Society, Washington, p 266... 

Many important food aromas originate from biochemical pathways. These pathways comprise microbial reactions, endogenous and exogenous enzymatic action, and plant metabolism. In the past, flavour research concentrated on characterising the important chemicals in foods responsible for their specific aroma. Less information is therefore available on the biogeneration of flavours. At present, however, a renaissance of studies of natural flavours, including their biogeneration can be observed [1]. 

Braell PA, Acree TE, Butts RM, Zhou PG (1986) In Biogeneration of Aromas (Parliment TH, Crouteau R, eds.) American Chemical Society, Washington, DC, pp 75-84. 

IMSHealth.com. Biogenerics a difficult birth http //open.imshealth.com/web-shop2/I MSinclude I article 20040518a. asp. 

Schellekens H, Ryff JC Biogenerics the off-patent biotech products. Trends Pharmacol. Sci. (2002) 23 119-121. 

The purpose of this book is to review aromas that are developed by thermal processes. Because the flavor of heated foods is affected principally by aroma, we focus attention exclusively on the volatile flavor constituents of foods. Moreover, we intend this book to complement the 1986 book. Biogeneration of Aromas, ACS Symposium Series 317, edited by Thomas H. Parliment and Rodney Croteau. A broader overview of the Maillard reaction was discussed in the 1983 book, The Maillard Reaction in Foods and Nutrition, ACS Symposium Series 215, edited by George R. Waller and Milton S. Feather, which addressed the volatile, nonvolatile, and nutritional aspects of the Maillard reaction. 

The principle that the process makes the product is mitigated in cases where the product is considered well characterized and can be easily characterized by well-refined analytical tools. A biogeneric is not identical but comparable. As an example, human growth hormone is being produced by five different companies in Europe through different processes and expression systems even so, all the processes seem to result in products presenting the same amino acids sequence profile, potency, safety, and efficacy (Polastro and Little, 2001). 

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