Biosimilars Ive Nzvimbo, Asi Haisi Yakaenzana Nezvinyorwa zveBiologist
Chii Chinonzi Biologic?
A biologic rudzi rwemishonga inoumbwa mukati memusero mhenyu. Masayendisiti anogadzira mishonga ye biologic nekushandura DNA mune mamwe masero. Masero anoshandurwa kuitira kuti agadziriswe kuti adzore nokusingaperi. Kana kamese masero ari kukwanisa kuzvizvinyora, anowanzoshandurwa kuitira kuti agadzirirwe kuti agadzire an anti-seni iyo masayendisiti anoda.
Mune zvimwe zviyo zvinodhaka zvinoshandiswa kuporesa chirwere chinoputika (IBD) , ma antibodies akasika ndeaya anoshanda mukurwisa tumor-necrosis factor (TNF) .
Mishonga inonzi biologic inoshandiswa kurapa IBD ndeyeHumira (adalimumab) , Cimzia (certolizumab pegol) , Remicade (infliximab) , Tysabri (natalizumab), Simponi (golimumab) , uye Entyvio (vedolizumab) . Zvose izvi zvinonzi biologic mishonga inonzi michina inoshandiswa, uye inogadzirwa chete nemakambani akavakurudzira. Zvinhu zvakagadzirwa nemishonga, mune mishonga yemishonga, ndiyo michina mitsva iyo isiripo kubva kune imwe kambani, uye inogona kunge iri pasi pemutemo. Izvo zvakasikwa munzvimbo yakarongedzwa, yakagadziridzwa, yakasiyana zvikuru nemishonga-yakagadzirwa nemishonga.
Mimwe yemishonga inonzi biologic yakagadzirirwa IBD ndiyo TNF inhibitors. Vanhu vane IBD vanowanzova nehuwandu hweTFF mumitumbi yavo kupfuura vanhu vasina BD, ndicho chikonzero TNF inofungidzirwa kuti inhengo yezvikonzero nei kuvhiringidza kunobatanidza neBD kuchiri kuitika uye kunopikisa gumbo rekudya.
Mishonga inopesana neTNF inoshanda nekuvhara TNF uye kudzivirira iyo kuti isakonzera kupisa. Entyvio inonzi gut-homing α4β7 integrin inopikisa iyo inoshanda nokudzivirira masero eropa eropa, ayo anofungidzirwa kuti anobatsira kupisa, kubva pakubata mukati memugwagwa wekudya.
Mishonga yeBiologic inoshandiswa kurapa mamiriro akawanda kupfuura IBD, iyo inoshandiswawo kubata dzimwe zvirwere zvekudzivirira muviri kana zvirwere zvemuviri zvakadai se rheumatoid arthritis, psoriasis, ankylosing spondylitis, uye hidradenitis suppurativa.
Ndezvipi Zvinyorwa Sezvakaita Zvizvarwa?
Biosimilars inowanzotsanangurwa se "generic" yemishonga inonzi biologic. Zvisinei, iyi haisi iyo nzira yakarurama yekutsanangura biosimilar. Apo patinopinda mune imwe mishonga yemishonga, tinowanzova nesarudzo yekutumidza zita-chigadzirwa chechirwere, uye mishonga inokwana bioquivalent - a generic. Kana iwe ukatarisa pakapetwa pamishonga miviri, unoona zvinoshandiswa zvinoshandiswa zvakafanana.
Kuti kambani ikwanise kutengeserana nemaitiro, FDA inofanira kubvumirana kuti chimiro chinoshandurana chinoshandiswa nechinangwa chigadzirwa. Izvi hazvirevi kuti chimiro chakangofanana, zvakadaro. Ikoko kunogona kunge kuine kusiyana kwezvinhu zvisingaitiki, asi zvinoshandiswa zvinoshanda, maererano neCDA, yakafanana.
A biosimilar inobvumirwa neRDA uye inofanirwa kuva yakafanana neye biologic inayo:
- Mechanism of action
- Nzira yekufambisa (yakadai sokukanganiswa kana injection)
- Dosage
- Strength
Bhiosimilar haina kufanana ne biologic, zvisinei, uye zvimwe zvakasiyana zvinobvumirwa. Izvo zvakasikwa uye kusikwa kwemishonga ye biologic zvakaoma zvakakwana kuti biosimilar haizove yakangofanana neye biologic. Nemhaka yokuti hatina dhesi yakawanda dhezvino, nyanzvi dziri mukusawirirana pamusoro pekuti biosimilar ichashanda zvakafanana nenzira iyo biologic inoita.
Panguva yemusangano weJanssen-yakagadzirwa nesayenzi shure kwehupenyu hwehupenyu, Michael Yang, Mutungamiriri we Immunology paJanssen Biotech akati "biologics iri kurarama mapuroteni, uye mapuroteni anorarama haagoni kukodhwa." Nokuti chibereko chebiologic chinokura mukati memhando chaiyo yesero, hachisi chimwe chinhu chinogona kudzokororwazve. Bhiosimilar ichave yakasiyana neye biologic, nenzira imwechete iyo, sezvinotsanangurwa Yang, imwe miti yemouki yakasiyana neimwe, kunyange zvazvo iyo yose inorondedzerwa semiti yemuaki.
Chii Chingaita IBD Varwere?
Sezvo mamwe mabhiosimilar ari kuuya pamusika, kuchava nemishonga yakawanda yemishonga inowanika kuvanhu vane Crohn's disease uye ulcerative colitis.
Varwere vanogamuchira madhigiriki zvinodhaka kana mishonga yebiosimilar vanofanira kuzviziva nemitemo yavo mune zvehupenyu maererano ne biologics uye biosimilars.
Vasati vawana kuvharwa pamusana wekamupa kana chipatara, varwere vanogonawo kukumbira kuti vaone kuti vari kuwana mishonga chaiye iyo chiremba wavo akarayira, "sezvakanyorwa." Bhiosimilar inofanira kuva nezita rakasiyana nedzimwe zita pane biologic, saka kuverenga iyo zita remishonga inokosha. Kana hupfumi hwako husina mutemo, kana mutemo hauna simba zvakakwana, taura nevamiririri vako vekune imwe nyika kuti uone kuti vanoziva maonero ako, semurwere akabatwa nemitemo iyi.
Kunobva:
Cauchi R. "State Law and Legislation Related to Biologic Medication and Substitution of Biosimilars." National Conference of State Legislatures. Jan 4 2016.
US Food and Drug Administration. "Mashoko eVatengi (Biosimilars)." FDA.gov. Aug 27 2015.