Biosimilars for psoriasis: preclinical analytical assessment to determine similarity
Por:
Blauvelt, A, Cohen, AD, Puig, L, Vender, R, van der Walt, J, Wu, JJ
Publicada:
1 feb 2016
Resumen:
Biosimilars, sometimes called 'generic biologics', are no longer a vision for the future but a present-day reality. Drug manufacturers and regulatory authorities are charged with ensuring that these products are safe and effective. Because biologically produced medications are large, complex proteins, many factors affect the quality of the end product, including glycosylation and presence of impurities, and thus many factors need to be compared between an emerging biosimilar and its originator biologic. Indeed, preclinical analytical assessments to determine similarity to an originator biologic are critical and are considered to be the foundation for regulatory approval of biosimilars. Here, the science behind the preclinical development of biosimilars is discussed by members of the International Psoriasis Council, and suggestions are put forth to try to ensure that future biosimilars are produced in a high quality and standardized manner.
Filiaciones:
Blauvelt, A:
Oregon Med Res Ctr, Portland, OR USA
Cohen, AD:
Ben Gurion Univ Negev, Fac Hlth Sci, Siaal Res Ctr Family Med & Primary Care, IL-84105 Beer Sheva, Israel
Clalit Hlth Serv, Chief Physicians Off, Dept Qual Measurements & Res, Tel Aviv, Israel
Puig, L:
Univ Autonoma Barcelona, Hosp Santa Creu & St Pau, Dept Dermatol, E-08193 Barcelona, Spain
Vender, R:
Dermatrials Res Inc, 132 Young St, Hamilton, ON L8N 1V6, Canada
van der Walt, J:
Int Psoriasis Council, St Louis, MO USA
Wu, JJ:
Kaiser Permanente Los Angeles Med Ctr, Dept Dermatol, 1515 North Vermont Ave,5th Floor, Los Angeles, CA 90027 USA
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