Akatswiri Ambiri Ali Ndi Malo, Koma Iwo Sali Ofanana Kwa Zamoyo
Kodi Biologic Ndi Chiyani?
Biologic ndi mtundu wa mankhwala omwe amapangidwa mkati mwa selo yamoyo. Asayansi amapanga mankhwala a biologic mwa kusintha DNA m'maselo ena. Maselo amasinthidwa kuti apangidwe kuti azisintha mpaka kalekale. Maselo akatha kudzipangitsa okha, amasinthidwanso kuti apangidwe kuti apange antibody yomwe asayansi akufuna.
Pankhani ya mankhwala osokoneza bongo omwe amagwiritsidwa ntchito pochizira matenda opatsirana (IBD) , ma antibodies omwe amapangidwa ndiwo omwe amatsutsana ndi tumor-necrosis factor (TNF) .
Mankhwala omwe amagwiritsidwa ntchito popanga IBD ndi Humira (adalimumab) , Cimzia (certolizumab pegol) , Remicade (infliximab) , Tysabri (natalizumab), Simponi (golimumab) , ndi Entyvio (vedolizumab) . Mankhwala onsewa amachititsa kuti azipanga zinthu zatsopano, ndipo amapangidwa okha ndi makampani omwe adawapanga. Zamakono zogulitsa, mu makampani ogulitsa mankhwala, ndi zatsopano zomwe sizipezeka ku kampani ina, ndipo zikhoza kukhala pansi pa chivomerezo. Zimapangidwa mu malo olamulidwa, osinthidwa, omwe ndi osiyana kwambiri ndi mankhwala omwe amachokera ku mankhwala.
Mankhwala ena omwe amapangidwa ndi IBD ndi TNF inhibitors. Anthu omwe ali ndi IBD nthawi zambiri amakhala ndi TNF m'matupi awo kusiyana ndi anthu opanda IBD, chifukwa chake TNF imaganiza kuti ndi chifukwa chake kutupa kwa IBD kukupitirira ndipo kumakhudzanso matenda.
Mankhwala odana ndi TNF amagwira ntchito mwa kutseka TNF ndi kupewa kuti zisapangitse kutupa. Entyvio ndi chigwirizano cha gutha-homing α4β7 integrin imene imagwira ntchito poletsa maselo oyera a magazi, omwe amaganiziridwa kuti amachititsa kutupa, kuti asagwire mkati mwa chigawo cha m'mimba.
Mankhwala amatsenga amagwiritsidwa ntchito pochiza matenda ambiri kuposa IBD, amagwiritsidwanso ntchito kuchiza matenda ena otetezedwa ndi chitetezo kapena chitetezo cha mthupi monga matenda a nyamakazi, psoriasis, ankylosing spondylitis, ndi hidradenitis suppurativa.
Kodi Amatsenga Ambiri Monga Achibadwa?
Kafukufuku amadziwika kuti "generic" ya mankhwala a biologic. Komabe, iyi si njira yolondola yofotokozera biosimilar. Tikamalowa mankhwala osokoneza bongo, nthawi zambiri timasankha kugula dzina la mankhwala, ndi mankhwala a bioequivalent - generic. Ngati mutayang'ana pazitsulo za mankhwalawa onse awiri, mudzawona zogwirira ntchito zomwezo ndizofanana.
Kuti kampani igule ma generic, a FDA ayenera kuvomereza kuti generic ndi osinthasintha ndi mankhwala atsopano. Izi sizikutanthauza kuti generic ndi chimodzimodzi, komabe. Pakhoza kukhala kusiyana pakati pa zopangira zosavomerezeka, koma chogwiritsidwa ntchito ndi, malinga ndi FDA, zomwezo.
A biosimilar amavomerezedwa ndi FDA ndipo ayenera kukhala ofanana biologic yake:
- Njira yogwirira ntchito
- Njira yoyendetsera (monga kulowetsedwa kapena jekeseni)
- Mlingo
- Mphamvu
Koma biosimilar si ofanana ndi biologic, komabe, komanso kusiyana kumaloledwa. Kupanga ndi kulengedwa kwa mankhwala osokoneza bongo ndi kovuta kuti biosimilar sidzakhala chimodzimodzi ndi biologic. Chifukwa tilibe deta zambiri za sayansi, akatswiri akutsutsana pazomwe biosimilar idzagwira chimodzimodzi momwe biologic imachitira.
Pamsonkhano wa Janssen wokhala ndi sayansi ya sayansi ya zamoyo, Michael Yang, Purezidenti wa Immunology ku Janssen Biotech anati "zamoyo ndi mapuloteni, ndipo mapuloteni amoyo sangathe kukopera." Chifukwa chomera cha biologic chimakula mkati mwa mtundu winawake wa selo, si chinthu chomwe chingabwererenso. Biosimilar idzakhala yosiyana ndi biologic, monga momwe Yang akufotokozera, mtengo umodzi wa thundu ndi wosiyana ndi wina, ngakhale kuti onsewa amadziwika ngati mitengo ya thundu.
Kodi Odwala a IBD Angatani?
Pamene zinthu zambiri zamagetsi zimabwera kumsika, padzakhala zosankha zambiri za mankhwala zomwe zili ndi anthu omwe ali ndi matenda a Crohn ndi matenda a zilonda zam'mimba.
Odwala omwe akulandira mankhwala osokoneza bongo kapena mankhwala osokoneza bongo ayenera kudzidziŵa okha ndi malamulo omwe ali nawo pankhani ya biologics ndi biosimilars.
Asanalandire kulowetsedwa pa malo osungirako mankhwala kapena kuchipatala, odwala angapemphe kuti atsimikizire kuti akulandira mankhwala enieni omwe dokotala wawo wanena kuti, "monga momwe analembera." A biosimilar ayenera kukhala ndi dzina losiyana ndi biologic, kotero kuwerenga chilemba pa mankhwala n'kofunika. Ngati dziko lanu liribe lamulo, kapena lamulo silili lokwanira, funsani oimira anu kuti muwone kuti amadziwa maganizo anu, monga wodwalayo atakhudzidwa ndi malamulo awa.
Chitsime:
Cauchi R. "Malamulo a Malamulo ndi Malamulo Zokhuzana ndi Mavitamini a Zamoyo ndi Kuyika kwa Anthu Ochita Zachakudya." Msonkhano Wachigawo wa Malamulo a boma. Jan 4 2016.
US Food and Drug Administration. "Chidziwitso kwa Ogulitsa (Asayansi)." FDA.gov. Aug 27 2015.