Requirements for Biosimilar Authorization: A Legal and Comparative Perspective – FDA Versus EMA

Peña, Alfonso Noguera; Rodríguez, Carlos del Castillo

doi:10.18520/cs/v120/i1/56-65

Cited by 5 publications

(2 citation statements)

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“…Es en este contexto, en el que los recursos económicos son limitados, se constatan terribles desigualdades en el acceso los medicamentos, y debido a la necesidad de los gobiernos de suministrar medicamentos para satisfacer a las demandas de salud por parte de la población, los medicamentos biosimilares cobran gran relevancia. Estos productos, de indudable interés social (13,16) se podrán introducir en los mercados una vez que hayan expirado los derechos de explotación en exclusiva de la patente del medicamento biológico de referencia u original (17), y serán entonces comercializados a precios más reducidos frente a estos últimos.…”

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Los medicamentos biosimilares como medicamentos esenciales: reflexiones éticas y legales

Peña

Rodríguez

2023

mye

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El presente artículo recapacita sobre las reformas normativas acontecidas en las últimas décadas respecto al uso racional de los medicamentos, y las medidas operadas en torno a la disminución del gasto farmacéutico. En este contexto, debe destacarse el elevado coste de las terapias biológicas y las dificultades de acceso a las mismas —especialmente en los países en vías de desarrollo—. Los medicamentos biosimilares son poseedores de garantías sanitarias análogas —semejantes o equivalentes— a los medicamentos de referencia, pero no están sometidos a una protección por una patente y facilitan la accesibilidad a los pacientes, así como al reparto equitativo de los recursos terapéuticos. Además, algunos de ellos están incluido en la lista de medicamentos esenciales de la Organización Mundial de la Salud (OMS).Asimismo, se examina el papel de los medicamentos biosimilares como esenciales y la posibilidad de mejorar el acceso equitativo a estos recursos sanitarios a través de la prestación farmacéutica.

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Section: Relevanciaunclassified

Los medicamentos biosimilares como medicamentos esenciales: reflexiones éticas y legales

Peña

Rodríguez

2023

mye

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“…The review will detail the minimal threshold technical requirements that are expected to be included within an adalimumab biosimilar dossier to ensure high similarity between reference adalimumab and its biosimilars. The EMA guidelines have set the primary principles for non-clinical and clinical requirements needed to establish the comparability between a reference mAb and its biosimilar [16]. Accordingly, the review will build on EMA guidelines and provide the detailed analytical, biological and clinical aspects needed for a rigorous biosimilarity exercise for adalimumab.…”

Section: Introductionmentioning

confidence: 99%

A Pharmaceutical Guide to Adalimumab Biosimilars

Almaaytah¹

2022

FARMACIA

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The development of monoclonal antibodies has revolutionized the pharmaceutical industry by offering clinicians a wide range of therapeutic agents for the treatment of a variety of disorders. Unlike small molecule drugs, monoclonal antibodies are large and complex molecules that are generated using genetically engineered living cells. Due to the high complexity of this class of molecules, producing exact copies is impossible and with several originator biological agents losing their patents in recent years, several pharmaceutical manufacturers are pursuing the development of generic biopharmaceuticals or what is known as "biosimilars" as alternative biological therapeutics. Adalimumab represents one of the most prescribed monoclonal antibodies in clinical practice. With the originator adalimumab losing its patency in 2018, several manufacturers are pursuing the development of adalimumab biosimilars with varying degrees of quality and thus exposing different markets to biosimilars of inferior quality or what is known as intended copies. These molecules could pose a major harm to patients as a result of the unexpected immunogenicity or lack of efficacy that results from their lack of similarity to the originator biologic. The aim of this review is to provide technical guidance for the pharmaceutical personnel working in research and development of adalimumab biosimilars in addition to regulatory assessors' worldwide reviewing biosimilars dossiers within public health authorities. The review article will detail all the development stages needed for the development of adalimumab biosimilars within the comparability exercise that is required by manufacturers to provide regulatory agencies with strong evidence of adalimumab biosimilarity. RezumatApariția anticorpilor monoclonali a revoluționat industria farmaceutică, oferind clinicienilor o gamă largă de agenți terapeutici pentru tratamentul multor afecțiuni. Spre deosebire de substanțele medicamentoase cu molecule mici, anticorpii monoclonali sunt molecule mari și complexe, generate de celule vii modificate genetic. Ținând cont de expirarea patentelor pentru agenți biologici inovatori, producătorii urmăresc dezvoltarea de biofarmaceutice generice sau ceea ce se cunoaște sub denumirea de "biosimilare". Adalimumab reprezintă unul dintre cei mai prescriși anticorpi monoclonali în clinică. O dată cu expirarea patentului adalimumabului în 2018, mai mulți producători urmăresc dezvoltarea de biosimilare. Acestea pot avea grade diferite de calitate și, astfel, expun pacienții la biosimilare de calitate inferioară. Aceste molecule ar putea aduce un prejudiciu major, ca urmare a imunogenității neașteptate sau a lipsei de eficacitate care rezultă din lipsa de similitudine a acestora cu substanța biologică originală. Scopul acestui review este de a orienta personalul farmaceutic care lucrează în cercetarea și dezvoltarea biosimilarelor cu adalimumab. Acest studiu detaliază toate etapele de dezvoltare necesare pentru biosimilarele cu adalimumab, cu scopul de a oferi agențiilor de r...

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Basis for fulfilling responsibilities, behavior, and professionalism of government agencies and effectiveness in public–public collaboration for food safety risk management

Wu,

Zhang,

2023

Humanit Soc Sci Commun

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Food safety risk management is an important cross-boundary issue around the world from both theoretical and practical perspectives. Public–public collaboration is the most basic form of cross-boundary governance. This study investigates the main factors affecting the governance effectiveness in public–public collaboration for food safety risk management through a questionnaire survey in Jiangsu Province and Guangxi Zhuang Autonomous Region, China, using a multivariable linear regression model based on principal component analysis. The results show that although the governance effectiveness in public–public collaboration is affected by many factors, the most important of which are the behavior and capabilities of legislative, administrative regulation and enforcement, and environmental improvement government (public) agencies, professionalism of government agencies, and laws and regulations as the basis for government agencies to perform their responsibilities. This research provides a case study for the academic community to better understand the main problems facing public–public collaboration for food safety risk management in China. It also provides insights into promoting public–public collaboration in developing countries.

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Requirements for Biosimilar Authorization: A Legal and Comparative Perspective – FDA Versus EMA

Cited by 5 publications

References 0 publications

Los medicamentos biosimilares como medicamentos esenciales: reflexiones éticas y legales

Los medicamentos biosimilares como medicamentos esenciales: reflexiones éticas y legales

A Pharmaceutical Guide to Adalimumab Biosimilars

Basis for fulfilling responsibilities, behavior, and professionalism of government agencies and effectiveness in public–public collaboration for food safety risk management

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