WHO pre­qual­i­fies first generic hep­ati­tis C medicine

BioSpectrum (Asia) - - Who News -

WHO has pre­qual­i­fied the first generic ver­sion of so­fos­bu­vir, a critical medicine for the treat­ment of hep­ati­tis C. The devel­op­ment could ex­pand ac­cess to treat­ment by in­creas­ing the num­ber of qual­ity-as­sured generic medicines on the mar­ket. So­fos­bu­vir, 400 mg tablet, is man­u­fac­tured by My­lan Lab­o­ra­to­ries Ltd., In­dia.

WHO pre­qual­i­fi­ca­tion means the prod­uct can now be pro­cured by the United Nations and fi­nanc­ing agen­cies such as UNITAID, which now in­cludes co-in­fec­tion with HIV and hep­ati­tis C in the port­fo­lio of dis­eases it cov­ers. Coun­tries such as In­done­sia, Viet­nam, Cam­bo­dia, Myan­mar, Mon­go­lia, Nepal, Rwanda, Uganda, Kenya, Zam­bia, Ethiopia, Pak­istan and Egypt are al­ready procur­ing generic ver­sions of so­fos­bu­vir. The fact that WHO has pre­qual­i­fied one of those gener­ics will give them ex­tra guar­an­tee of the prod­uct’s qual­ity, safety and ef­fi­cacy.

The av­er­age price of the re­quired three-month treat­ment course of My­lan’s so­fos­bu­vir is around US$ 260, a small frac­tion of the medicine’s mar­ket en­try price in late 2013, and of the price set in the ma­jor­ity of high­in­come coun­tries.

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