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Challenges in demonstrating interchangeability and safety, as well as the ongoing evolution of regulations governing biosimilars, have meant that the development of the biosimilars industry has not been, and will not be, a carbon copy of the generics industry. Complexity in the development process reduces the cost advantages for biosimilars that generics offer over originators. There has been a marked difference in the number of biosimilars approved by the European Medicines Agency (EMA) and US FDA due to a lack of consensus and the different rates of progress in establishing both law and stable evidence-based regulatory guidelines for biosimilars. In this review, we provide a précis of the history and status of the regulatory regimes in the USA and Europe. Included is an assessment of market and nonmarket factors that may continue to influence the development of the biosimilars industry. [ABSTRACT FROM AUTHOR]

Abstract: The surface structure of the commercial carbon paper (CP) has been modified through thermal treatment, and then MnO2 was electrodeposited on the thermally-treated carbon paper (TTCP) by cyclic voltammetry (CV) method in the phosphate buffer solution (PBS, pH 9.18) containing KMnO4. The obtained samples were characterized by X-ray diffraction (XRD), X-ray photoelectron energy spectroscopy (XPS) and scanning electron microscopy (SEM). The results showed that the phase of the obtained MnO2 was amorphous, and that the morphology of the MnO2 deposited on the substrates was influenced strongly by the substrates. The capacitive properties of MnO2 deposited on the carbon substrates were investigated by CV, galvanostatic charge/discharge, electrochemical impedance spectroscopy technique. It was found that the specific capacitance of MnO2 deposited on the optimum TTCP can reach to 749Fg−1 based on the charge/discharge measurement, which was far larger than that on the CP (345Fg−1). [Copyright &y& Elsevier]

In any editorial office it is periodically required to dispose of out-dated files of duplicate copies of manuscripts and galley proofs. On June 1, 1972, all such material will be destroyed unless an author wishes to request the return of carbon copies or illustrative material by contacting the editorial office of the "Journal of Investigative Dermatology," prior to that date.