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Europeiska kommissionen godkänner mAbxience's Bevacizumab för behandling av vissa typer av cancer


News provided by

mAbxience

Mar 31, 2021, 04:30 ET

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mAbxience, är ett globalt heltäckande bioteknikföretag med över ett decenniums erfarenhet av utveckling, tillverkning och kommersialisering av biofarmaka , som utökar patientens tillgång till biologiska behandlingar i hela Europa.

MADRID, 31 mars, 2021 /PRNewswire/ -- Den 31 mars 2021, har Europeiska kommissionen (EG) godkänt mAbxience's MB02 biosimilar till Avastin ® (Bevacizumab), i Europa.

MB02, som kommer att marknadsföras som Alymsys® och Oyavas®, är mycket lik referensläkemedlet och data har visat en jämförbar kvalitet, säkerhet och effekt med Avastin®. MB02 är avsett för behandling av karcinom i tjocktarmen eller ändtarmen, bröstcancer, icke-småcellig lungcancer, njurcellscancer, ovarial cancer -, äggledar- eller primär peritoneal cancer och karcinom i livmoderhalsen.

"Vi bevittnar för närvarande en period av vital betydelse globalt, med ett centralt fokus på hälso- och sjukvårdssystemet och dess hållbarhet", säger Emmanuelle Lepine, General Manager på mAbxience.

"Lanseringen av vår Bevacizumab under varumärkena Alymsys® och Oyavas® på den europeiska marknaden kommer att vara ett perfekt exempel på hur innovation och banbrytande FoU-teknik kan tillämpas för att erhålla en högkvalitativ, prisvärd medicin som ger alternativ för hälso- och sjukvården och kommer också att förbättra patienternas tillgång till dyra behandlingar. "

Om mAbxience

mAbxience är ett helt integrerat globalt biofarmaceutiskt företag som specialiserat sig på utveckling, tillverkning och kommersialisering av monoklonala antikroppar och ingår i läkemedelskoncernen Insud Pharma. MAbxience grundades 2010 och driver tre toppmoderna anläggningar i Spanien och Argentina. mAbxience arbetar med flera biofarmaceutiska produkter som sträcker sig till olika terapeutiska områden. År 2014 lanserade mAbxience sitt första biosimilar, Rituximab (Produktkod: RTXM83-MB01), som nu är godkänd och marknadsförs på en rad marknader över hela världen. Dess andra produkt, Bevacizumab (produktkod: BEVZ92-MB02), utvecklades och lanserades först i Latinamerika år 2016.

mAbxience arbetar för kvaliteten, säkerheten och effekten av sina läkemedel. MAbxience-teamet brinner för patientvård och utökar tillgången till sina biofarmaceutiska läkemedel över hela världen. Företagets uppdrag är att förbättra patienternas tillgång till kvalitetsbehandlingar för tillstånd som kräver dyra läkemedel och positivt bidra till hållbarheten i hälso- och sjukvårdssystemen.

Insud Pharma Group grundades av Dr. Hugo Sigman och Dr. Silvia Gold och har över 40 års erfarenhet inom läkemedelssektorn och sysselsätter över 6 000 yrkesverksamma över hela världen.

Ansvarsfriskrivning

Några av uttalandena i detta pressmeddelande, andra än uttalanden om historiska fakta, kan vara framåtblickande uttalanden eller uttalanden om framtida förväntningar baserat på tillgänglig information. Sådana uttalanden är naturligtvis föremål för risker och osäkerhetsfaktorer, samma som vår verksamhet, liksom varje produkt vi utvecklar och marknadsför, är föremål för olika risker och osäkerhetsfaktorer utanför vår kontroll. Framåtblickande uttalanden representeras av mAbxience-ledningens bedömning från och med dagen för detta meddelande och mAbxience avstår från att göra gällande någon avsikt eller skyldighet att uppdatera eventuella framåtblickande förklaringar som finns i denna, vid utfärdandet detta datum.

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