Generic biologies

Grabowski HG, Ridley DB, Schuknan KA. Entry and competition in generic biologies. Managerial and Decision Economics 2007 28 439-51. 

That documentation of pharmaceutical- and bio-equivalence should be provided to regulatory authorities is not at issue. However, the means by which these data can and should be demonstrated remain the subject of discussion. Political, economic and scientific hurdles pervade, and this issue remains unresolved. The imposition of existing small-molecule equivalence criteria on the registration of generic biologic drug products is unlikely to provide an acceptable degree of consumer protection. Likewise, the conventional bioequivalence trial used to infer therapeutic equivalence of different formulations based on the similarity of the phar-... 

Waxman, H., Schumer, C. E., and Clinton, H. R. (2006), Congress of the United States, H.R. 6257, Access to Life-Saving Medicine Act, available http //www.waxman.house. gov/pdfs/bill generic biologics 9.29.06.pdf, accessed Sept. 29, 2006. 

The creation of generic biological products currently is controversial and fraught with difficult manufacturing... 

In ASTM F78-98 Standard Practice for Selecting Generic Biological Tests Methods for Materials and Devices , the selection test methods to evaluate medical devices is described. Regarding hemocompatibility tests for blood compatibility, hemolysis, and complement activation are described. Under blood compatibility, hemolysis and thrombosis are described as the most obvious examples of incompatibility with blood. It is suggested that thrombogenicity (formation of thromboemboli or platelet activation) be tested under dynamic conditions that simulate in the use procedures for the device. Complement activation is of concern in some cases and should be tested in vitro by assessing the status of various complement components. However, complement activation will probably not represent the only portion of the inflammatory response stimulated by medical devices. 

One critical issue may be that of immunogenicity. This must always be investigated, and a plan for a post-marketing monitoring must be included in any generic biological product application. 

ASTM F 748-06. (2010) Practice for Selecting Generic Biological Test Methods for Materials and Devices, ASTM International, West Conshohocken, PA. 

Urry DW, Parker TM, Reid MC, Gowda DC. Biocompatibility of the bioelastic materials, poly (GVGVP) and its gamma-irradiation cross-linked matrix - summary of generic biological test results. J Bioact Compatible Polym 1991 6 263-282. 

ASTM F-748-98 Selecting generic biological test methods for materials and devices. 

According to the ASTM 1987 Standard Practice for Selecting Generic Biological Test... 

D.W. Urry, T.M. Parker, M.C Reid, and D.C. Gowda, Biocompatibility of the Bioelastic Materials, Poly(GVGVP) and Its y-irradiation Cross-linked Matrix Summary of Generic Biological Test Results. J. Bioactive Compatible Pofyw., 6,263-282,1991. 

Uny, Dan W., Parker, Timothy M., Reid, Michael C. and Gowda, D. Channe (1991) Biocompatibility- of the bioelastic materials, poly(GVGVP) and its p-irradiation cross-linked matrix Summary of generic biological test results, / Bioactive Compatible Polym., 6, 263-282. 

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