Zamoyo, zomwe zimatchedwa mankhwala ochizira kapena biologic mawonekedwe, ndi mayesero, zothandizira, ndi mankhwala omwe anapangidwa ndipo amapangidwa kudzera mu njira zamoyo pogwiritsa ntchito anthu, nyama kapena tizilombo toyambitsa matenda. Izi zimasiyana ndi mankhwala osokoneza bongo, omwe amapangidwa kuchokera ku mankhwala.
Pali chiwerengero chilichonse cha zinthu zomwe zimachokera kwa anthu, nyama kapena tizilombo toyambitsa matenda zomwe zimagwiritsidwa ntchito mu mankhwala, monga shuga, mapuloteni, zida za nucleic, maselo, magazi kapena matenda.
Pogwiritsira ntchito zipangizo zamagetsi, zimagwirizanitsidwa kuti zikhazikitse zinthu zomwe zingatithandize kuthandizira, kuchiza, kusamalira, kapena kuchiza matenda ndi zikhalidwe.
Zina mwa zamoyo zoyambirira zamoyo ndi insulini , yomwe inali yoyambirira kuchokera ku zinyama. Masiku ano mankhwala a insulini amapezeka chifukwa cha DNA yowonjezera, njira yosiyana, koma ndi chilengedwe.
Katemera ndi zamoyo zomwe zakhala zikupezeka kwa zaka zambiri. Zimapangidwa pogwiritsa ntchito kachilombo ka HIV kapena mabakiteriya omwe amachititsa kuti matendawa asatetezedwe. Izi zikhoza kupha matendawa, kapena akhoza kukhala mapuloteni oyeretsedwa, shuga kapena kachilombo kena.
Mwa kuyika munthu wina kukonzekera kumeneku kuchokera ku kachilombo ka HIV kapena mabakiteriya omwe ali nawo musanayambe kudwala, thupi limagwira ntchito pomanga tizilombo toyambitsa matenda. Pambuyo pake, ngati awonetseredwa, wodwala sangayambe matendawa.
Njirayi ndiyonse yamoyo.
Zoyezetsa zina ndi zochiritsira zina ndizochilendo, nayenso. Zida zamagazi zomwe zimagwiritsidwa ntchito poika magazi , zoyezetsa magazi ndi mafupa ambirimbiri, mankhwala ochizira amphongo monga omwe amagwiritsidwa ntchito pochita zizindikiro za kusamba kwa mimba, komanso mankhwala omwe amagwiritsidwa ntchito popangira kapena kukonza ma bilogic ena onse amadziwika kuti ndi a biologics.
Mndandanda wa Zamoyo
Kuphatikizidwa kuchokera kuzinthu zosiyanasiyana, apa pali mndandanda wamakono wa biologics:
- katemera
- insulini
- interleukins
- mahomoni owonjezeka a anthu
- mankhwala a hormone, monga kugwiritsa ntchito estrogen kapena testosterone
- mayesero kuti athe kusindikiza opereka magazi omwe ali ndi HIV kapena othandizira ena
- magazi ndi mankhwala a magazi chifukwa cha kuikidwa magazi
- magazi ndi mankhwala omwe amagwiritsidwa ntchito popanga zinthu zina
- Zotsatira za biologic zomwe zimagwiritsidwa ntchito kuti zikhale zovuta zowononga komanso zozizira
- maselo aumunthu ndi ziphuphu zomwe zimagwiritsidwa ntchito popatsa (mwachitsanzo, matope, ligaments, ndi fupa)
- jini (DNA) mankhwala (onani m'munsimu)
- mankhwala othandizira (onani m'munsimu)
Zonsezi zimagulitsidwa pansi pa dzina lachizindikiro lomwe lingakhale lodziwika bwino, monga Avastin, Herceptin, Enbrel, Epotin, Remicade, Huma kapena Avonex.
Zamoyo Zilibe Zomwe Zikuimira Zofanana Zachibadwa
Mosiyana ndi mankhwala achikulire omwe amapezeka mankhwala ambiri, biologics sichidziwikiratu kuti ndizofanana zowonjezera . The FDA imanena generics monga chimodzimodzi yogwira ntchito monga mankhwala dzina-mankhwala. Osati kokha, koma amakhalanso ofanana - ali ndi mawonekedwe ofanana, mphamvu, khalidwe, ndi ntchito. M'malomwake, zamoyo ndi zamoyo, zomwe zimatanthauzidwa ndi lamulo mu 2009.
Akatswiri
Odziwika bwino ndi mankhwala ovomerezeka ndi a FDA omwe alibe kusiyana kwakukulu kochokera ku dzina loyambirira la biologic agent.
Ayenera kukhala otetezeka komanso othandiza komanso ogwira ntchito mofananamo monga momwe akugwirira ntchito. Mankhwala amatchedwa kusinthanitsa ngati akukumana ndi chiwerengero cha biosimilarityity ndipo ayenera kusinthidwa ndi mankhwala oyambirira popanda kuwonjezeka pangozi.
Chiwerengero cha mankhwala osokoneza bongo chinali choletsedwa ku United States mpaka patsiku la Care Care Act 2010. Pogwiritsa ntchito Biologicals Price Competition ndi Innovation Act (BCPI) ya 2009 ndi Patient Protection ndi Affordable Care Act ya 2010, zamoyo Zogulitsa zili ndi njira yovomerezeka ya FDA.
Mankhwala osokoneza bongo komanso osinthasintha angapezeke ku United States ndi kusintha kwalamulo.
Asanafike mu 2009, magulu ambiri adayesetsa kulimbikitsa a FDA kuti ayambe kupanga zolemba zamakono kapena zotsatila za biologics yakale monga njira yopulumutsira ndalama zachuma. Mwachitsanzo, kutchulidwa kwa insulini ndi mankhwala a mtundu wa insulini kungadye kuchokera pa $ 150 mpaka $ 1000 pamwezi. Zotsatira zofanana zitha ndalama zokwana $ 25 pamwezi. Mukachulukitsidwa ndi chiwerengero cha anthu omwe akusowa mankhwalawa, mukhoza kuona momwe chiyanjano cha biologics ichi chikhoza kupulumutsa mabiliyoni.
Akatswiri opanga biologic amatsutsana ndi chitukuko ndi kupanga zida zazing'ono chifukwa sankasowa kupikisana ndi mankhwala otsika mtengo, koma othandiza (kutsatira ndalama). Iwo anatchula mavuto a chitetezo mu ndondomeko ya chitukuko ndi kusowa umboni wakuti mankhwalawa angakhale othandiza monga oyambirira.
Kuchokera
Information kwa Ogulitsa (Ofufuza) - US Food and Drug Administration 8/27/2015.