{"id":22680,"date":"2024-02-20T14:29:44","date_gmt":"2024-02-20T13:29:44","guid":{"rendered":"https:\/\/kymos.com\/news\/liraglutida-i-semaglutida-explorant-estudis-biosimilars-per-a-agonistes-del-receptor-glp-1\/"},"modified":"2026-01-22T15:40:35","modified_gmt":"2026-01-22T14:40:35","slug":"liraglutida-i-semaglutida-explorant-estudis-biosimilars-per-a-agonistes-del-receptor-glp-1","status":"publish","type":"post","link":"https:\/\/kymos.com\/ca\/news\/liraglutida-i-semaglutida-explorant-estudis-biosimilars-per-a-agonistes-del-receptor-glp-1\/","title":{"rendered":"Liraglutida i semaglutida: explorant estudis biosimilars per a agonistes del receptor GLP-1"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">La liraglutida i la semaglutida s&#8217;han convertit en actors clau en la ind\u00fastria farmac\u00e8utica i sanit\u00e0ria, ja que ambdues s&#8217;utilitzen i han estat aprovades no nom\u00e9s com a medicament antidiab\u00e8tic, sin\u00f3 tamb\u00e9 com a tractament per a l&#8217;obesitat i la p\u00e8rdua de pes.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">En combinaci\u00f3 amb l&#8217;enorme creixement del mercat de biosimilars en els darrers anys i les seves dates de caducitat de patents, s\u00f3n un dels objectius principals per al desenvolupament i llan\u00e7ament de nous f\u00e0rmacs biosimilars basats en ells. En aquest article, aprofundirem en aquests dos agonistes del receptor GLP-1 i com Kymos pot ajudar en els estudis de caracteritzaci\u00f3 i comparabilitat dels seus biosimilars i els serveis bioanal\u00edtics que oferim per a ells. <\/span><\/p>\n<p>&nbsp;<\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>Introducci\u00f3 a la liraglutida i la semaglutida<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">El p\u00e8ptid similar al glucag\u00f3-1 (GLP-1) \u00e9s una hormona incretina que t\u00e9 efectes importants sobre el control gluc\u00e8mic, ja que estimula la secreci\u00f3 d&#8217;insulina i inhibeix l&#8217;alliberament de glucag\u00f3, convertint-lo en el candidat perfecte per a un agent antidiab\u00e8tic terap\u00e8uticament efica\u00e7. Tanmateix, a causa del perfil farmacocin\u00e8tic del GLP-1, la seva semivida \u00e9s molt curta, ja que es degrada r\u00e0pidament (menys de 2 minuts intravenosos i 1-2 hores subcutanis), cosa que limita el seu potencial terap\u00e8utic en la seva forma nativa. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">A causa de la necessitat d&#8217;allargar aquesta semivida, es van desenvolupar tant la liraglutida com la semaglutida. Aquests agonistes del receptor del p\u00e8ptid-1 semblant al glucag\u00f3 (RA del GLP-1) tenen vides mitjanes allargades tot mantenint la pot\u00e8ncia, cosa que ha donat lloc a un tractament efica\u00e7 de la diabetis tipus 2. Es van desenvolupar mitjan\u00e7ant modificacions estructurals com l&#8217;acilaci\u00f3 amb una cadena d&#8217;\u00e0cids grassos per facilitar la uni\u00f3 a l&#8217;alb\u00famina, augmentant la seva semivida a 13 hores despr\u00e9s d&#8217;una sola injecci\u00f3 amb liraglutida, i despr\u00e9s es van refinar fins a una semivida plasm\u00e0tica humana m\u00e9s gran de 160 hores per a la semaglutida, que tamb\u00e9 est\u00e0 protegida de l&#8217;escissi\u00f3 de la dipeptidil peptidasa-4. Aquestes modificacions han fet possible una dosi di\u00e0ria per a la liraglutida i una dosi setmanal per a la semaglutida en les seves formes injectables.   <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Tot i que l&#8217;objectiu original d&#8217;aquests p\u00e8ptids era ser efica\u00e7os terap\u00e8uticament en persones amb diabetis tipus 2, els efectes sobre el pes corporal eren evidents i, a causa d&#8217;aquests, es van desenvolupar versions de Liraglutida i Semaglutida per al tractament de l&#8217;obesitat (la principal difer\u00e8ncia \u00e9s la quantitat de dosi; m\u00e9s baixa per a la diabetis i m\u00e9s alta per a la p\u00e8rdua de pes).<\/span><\/p>\n<p>&nbsp;<\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>Escasetat d&#8217;agonistes del receptor GLP-1<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">Tot i que aquests efectes terap\u00e8utics s\u00f3n beneficiosos tant per a pacients diab\u00e8tics com per a pacients amb sobrep\u00e8s, l&#8217;efecte de p\u00e8rdua de pes ha afectat considerablement el subministrament d&#8217;aquests f\u00e0rmacs. Ha afectat especialment la poblaci\u00f3 amb diabetis tipus 2. Actualment estem experimentant una escassetat mundial de subministrament a causa d&#8217;un augment de les prescripcions no autoritzades de les versions per a la diabetis que s&#8217;emeten per a la p\u00e8rdua de pes en lloc del seu \u00fas original previst.  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Analitzant la situaci\u00f3 actual pel que fa als agonistes del receptor GLP-1, les formulacions aprovades s\u00f3n les seg\u00fcents:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">Per a la liraglutida:<\/span>\n<ul>\n<li><span style=\"font-size: 14pt;\">Forma injectable per al tractament de la diabetis tipus 2<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Forma injectable per a la p\u00e8rdua de pes i l&#8217;obesitat<\/span><\/li>\n<\/ul>\n<\/li>\n<li><span style=\"font-size: 14pt;\">Per a la semaglutida:<\/span>\n<ul>\n<li><span style=\"font-size: 14pt;\">Forma injectable per al tractament de la diabetis tipus 2<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Forma injectable per a la p\u00e8rdua de pes i l&#8217;obesitat<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Comprimits orals per al tractament de la diabetis tipus 2<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">Tant per a la liraglutida com per a la semaglutida, hi ha una necessitat de m\u00e9s subministraments, ja que amb tots els medicaments que contenen aquests ingredients actius, hi ha una escassetat de subministrament global. Aquest problema es podria solucionar amb l&#8217;aparici\u00f3 de nous biosimilars, que es preveu que es llancin en els propers mesos i anys a mesura que s&#8217;acostin les dates de caducitat de les patents, i en el cas de la liraglutida, ja s&#8217;han produ\u00eft. <\/span><\/p>\n<p>&nbsp;<\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>Desenvolupament de biosimilars<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">El mercat dels biosimilars est\u00e0 fermament establert i en constant creixement a causa de l&#8217;aparici\u00f3 de nous f\u00e0rmacs i ingredients actius com la liraglutida i la semaglutida. Tanmateix, el seu desenvolupament presenta una gran complexitat i reptes. L&#8217;aprovaci\u00f3 reglament\u00e0ria de nous biosimilars requereix un extens exercici de comparaci\u00f3 amb productes de refer\u00e8ncia establerts i comercialitzats, ja que ha d&#8217;incloure estudis cl\u00ednics i de qualitat per demostrar un alt percentatge de similitud tant en termes d&#8217;estructura com de funci\u00f3.  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Els estudis de qualitat comparativa inclouen l&#8217;estructura de prote\u00efnes, la funci\u00f3 biol\u00f2gica i estudis farmacodin\u00e0mics in vitro. Han d&#8217;incloure an\u00e0lisis exhaustives del biosimilar proposat i del medicament de refer\u00e8ncia utilitzant m\u00e8todes sensibles i ortogonals per determinar: <\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">similituds<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Difer\u00e8ncies<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Rangs quantitatius de variabilitat en el medicament de refer\u00e8ncia<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">Els estudis cl\u00ednics comparatius estan dissenyats per confirmar la biosimilaritat i per abordar qualsevol dubte que pugui quedar pendent d&#8217;estudis anal\u00edtics o funcionals previs. Inclouen comparacions pel que fa a la farmacocin\u00e8tica i estudis de seguretat i efic\u00e0cia en estudis cl\u00ednics. <\/span><\/p>\n<p>&nbsp;<\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>L&#8217;experi\u00e8ncia de Kymos amb Liraglutida i Semaglutida  <\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">Kymos Group pot ajudar els desenvolupadors de biosimilars d&#8217;agonistes del receptor GLP-1 tant amb estudis de qualitat com de comparabilitat cl\u00ednica.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Per a estudis de comparabilitat de qualitat, oferim un cat\u00e0leg complet de t\u00e8cniques anal\u00edtiques d&#8217;avantguarda juntament amb una \u00e0mplia experi\u00e8ncia en la seva aplicaci\u00f3 a biosimilars. Concretament, per a Liraglutida i Semaglutida, els nostres departaments de biofarmac\u00e8utica i immunologia tenen experi\u00e8ncia amb: <\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">An\u00e0lisi FT-IR<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">An\u00e0lisi d&#8217;amino\u00e0cids<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Mapeig de p\u00e8ptids (an\u00e0lisi MS\/MS)<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Estudis de bioactivitat<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Electroforesi en gel<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">An\u00e0lisi de l&#8217;assaig de tioflavina T<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Assajos basats en c\u00e8l\u00b7lules (CBA) per a la pot\u00e8ncia<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">Per als estudis de comparabilitat cl\u00ednica, Kymos ofereix suport bioanal\u00edtic per als estudis de comparabilitat, que cobreix activitats com la mesura del nivell de s\u00e8rum\/plasma de prote\u00efnes de refer\u00e8ncia i biosimilars, c\u00e0lculs i estad\u00edstiques de PK, i estudis d&#8217;immunogenicitat. A m\u00e9s, tamb\u00e9 oferim una soluci\u00f3 completa de finestreta \u00fanica que inclou la part cl\u00ednica disponible a trav\u00e9s dels nostres socis de confian\u00e7a en assajos cl\u00ednics. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Pel que fa a la bioan\u00e0lisi,  <\/span><span style=\"font-size: 14pt;\">Hem desenvolupat m\u00e8todes bioanal\u00edtics per a diversos an\u00e0legs del GLP 1 en plasma de diferents esp\u00e8cies amb l\u00edmits de quantificaci\u00f3 en el rang baix de ng\/mL, la sensibilitat requerida per als estudis precl\u00ednics i cl\u00ednics actuals. Per als estudis de bioequival\u00e8ncia cl\u00ednica, la validaci\u00f3 del m\u00e8tode \u00e9s gratu\u00efta. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Si necessiteu ajuda amb els vostres biosimilars o qualsevol dels vostres estudis CMC o bioanal\u00edtics, poseu-vos <strong><a href=\"https:\/\/kymos.com\/contact\/\" data-wpel-link=\"external\">en contacte amb nosaltres<\/a><\/strong> o envieu-nos un correu electr\u00f2nic a <a href=\"mailto:commercial@kymos.com\" data-wpel-link=\"internal\">commercial@kymos.com<\/a><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>La liraglutida i la semaglutida s&#8217;han convertit en actors clau  [&#8230;]<\/p>\n","protected":false},"author":7,"featured_media":16044,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[95,97],"tags":[67],"class_list":["post-22680","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bioanalisi","category-cmc-ca","tag-carles"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Liraglutida i semaglutida: explorant estudis biosimilars<\/title>\n<meta name=\"description\" content=\"Descobreix per qu\u00e8 la Liraglutida i la Semaglutida s\u00f3n objectius principals per al desenvolupament de nous biosimilars i explora els serveis que Kymos ofereix per a ells.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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