Biosimilars in Dermatology: Current Situation (Part I).

The first biosimilar version of a biologic agent used to treat psoriasis (infliximab) entered the Spanish market on February 16 of this year, and more biosimilars can be expected to follow in the coming months and years. Logically, this new situation will have economic repercussions and alter prescribing patterns among dermatologists. In this article, we review regulatory issues related to the approval of biosimilars, with a particular focus on the situation in the European Union. We will examine analytical characterization studies and special considerations for clinical trials with biosimilars, and also look at several somewhat contentious issues, such as the extrapolation of indications, interchangeability, and automatic substitution. Finally, we will review the biosimilars with indications for psoriasis currently in the clinical development pipeline and assess their potential to offer comparable efficacy and safety to the reference product while contributing to the sustainability of the public health care system.

Biosimilars in Dermatology: Current Situation (Part II).

The first biosimilar version of a biologic agent used to treat psoriasis (infliximab) entered the Spanish market on February 16 of this year, and more biosimilars can be expected to follow in the coming months and years. Logically, this new situation will have economic repercussions and alter prescribing patterns among dermatologists. In this second part of the review, we will look at several somewhat contentious issues, such as the extrapolation of indications, interchangeability, and automatic substitution. We will also review the biosimilars with indications for psoriasis currently in the clinical development pipeline and assess their potential to offer comparable efficacy and safety to the reference product while contributing to the sustainability of the public health care system.

[Sociodemographic characteristics of spanish skin cancer patients]. / Características sociodemográficas del cáncer cutáneo en España.

INTRODUCTION: Most epidemiological studies of skin cancer have been performed in countries with very different population and geographic characteristics to Spain. Investigation of this disease in the Spanish population would therefore be of interest. METHOD: Over a 12-month period, this prospective study recorded the types of skin cancer in consecutive patients who attended a dermatology clinic for the first time in health care area 3 of the health service of the Spanish autonomous community of Murcia. The demographic and social characteristics of these patients were determined. The results obtained were analyzed with the SPSS program, version 11.5, and compared with other studies conducted in other countries. RESULTS: Malignant tumors were the third most common presenting complaint (16.9 %) and the fourth most common secondary complaint (8 %). The patients with skin cancer were older (69.52 years; 95 % confidence interval [CI], 67.82-71.21 years) than the other patients in the sample (34.52 years; 95 % CI, 33.23-33.81 years), and there were more men (51.7 %) than women (48.3 %). These individuals had a low level of schooling, which varied according to the type of tumor, and most had outdoor jobs, with a significantly higher exposure to sunlight (3.35 h/d; 95 % CI, 3.08-3.62 h/d) than the other patients (2.72 h/d; 95 % CI, 2.58-2.86 h/d). Furthermore, fewer malignant cutaneous tumors were found in patients with a higher phototype. The length of time since onset of the presenting complaints was shorter for skin cancer (11.37 months; 95 % CI, 7.47-15.26 months) than for other skin diseases (25.83 months; 95 % CI, 22.87-28.80). Also, there were no seasonal peaks in consultations for skin cancer, and treatment was essentially based on surgery and cryotherapy. In addition, more of these patients had follow-up visits (84 %) than other dermatology patients (33 %). CONCLUSIONS: Malignant or premalignant skin lesions are a common presenting skin complaint in the Mediterranean region, with differences in terms of attendance rates and predominant tumor type compared to other countries. This is probably due to the high sun exposure and predominance of skin phototype III. Similar studies for the whole of Spain would be of interest.

Biosimilares en dermatología. Situación actual (parte I) / Biosimilars in Dermatology: Current Situation (Part I)

El 16 de febrero de este año se han comercializado en España los primeros biosimilares de un tratamiento biológico para la psoriasis (infliximab), y en los próximos meses y años está prevista la incorporación de otros biosimilares, con un previsible impacto económico y en los hábitos de prescripción dermatológicos. En la presente revisión se abordan los aspectos regulatorios de la aprobación de biosimilares, con especial referencia al entorno de la Unión Europea, prestando especial atención a la caracterización analítica de la biosimilaridad y las consideraciones especiales referidas al diseño de ensayos clínicos con biosimilares. También se abordan aspectos objeto de cierta controversia, como la extrapolación de indicaciones, la intercambiabilidad y sustitución automática, los biosimilares en fase clínica de desarrollo con indicaciones que incluyen la psoriasis y unas consideraciones finales sobre el potencial de estos fármacos para proporcionar unas alternativas terapéuticas de eficacia y seguridad comparables a las de sus productos de referencia, contribuyendo a la sostenibilidad del sistema sanitario público

The first biosimilar version of a biologic agent used to treat psoriasis (infliximab) entered the Spanish market on February 16 of this year, and more biosimilars can be expected to follow in the coming months and years. Logically, this new situation will have economic repercussions and alter prescribing patterns among dermatologists. In this article, we review regulatory issues related to the approval of biosimilars, with a particular focus on the situation in the European Union. We will examine analytical characterization studies and special considerations for clinical trials with biosimilars, and also look at several somewhat contentious issues, such as the extrapolation of indications, interchangeability, and automatic substitution. Finally, we will review the biosimilars with indications for psoriasis currently in the clinical development pipeline and assess their potential to offer comparable efficacy and safety to the reference product while contributing to the sustainability of the public health care system

Biosimilares en dermatología. Situación actual (parte II) / Biosimilars in Dermatology: Current Situation (Part II)

El 16 de febrero de este año se han comercializado en España los primeros biosimilares de un tratamiento biológico para la psoriasis (infliximab), y en los próximos meses y años está prevista la incorporación de otros biosimilares, con un previsible impacto económico y en los hábitos de prescripción dermatológicos. En esta parte de la revisión se abordan aspectos objeto de cierta controversia, como la extrapolación de indicaciones, la intercambiabilidad y sustitución automática, los biosimilares en fase clínica de desarrollo con indicaciones que incluyen la psoriasis, y unas consideraciones finales sobre el potencial de estos fármacos para proporcionar unas alternativas terapéuticas de eficacia y seguridad comparables a las de sus productos de referencia, contribuyendo a la sostenibilidad del sistema sanitario público

The first biosimilar version of a biologic agent used to treat psoriasis (infliximab) entered the Spanish market on February 16 of this year, and more biosimilars can be expected to follow in the coming months and years. Logically, this new situation will have economic repercussions and alter prescribing patterns among dermatologists. In this second part of the review, we will look at several somewhat contentious issues, such as the extrapolation of indications, interchangeability, and automatic substitution. We will also review the biosimilars with indications for psoriasis currently in the clinical development pipeline and assess their potential to offer comparable efficacy and safety to the reference product while contributing to the sustainability of the public health care system

Características sociodemográficas del cáncer cutáneo en España / Sociodemographic characteristics of spanish skin cancer patients

Introducción. La mayoría de los estudio epidemiológicos acerca del cáncer cutáneo están realizados en países con características tanto poblacionales como geográficas muy diferentes a las españolas, por lo que resulta interesante conocer cómo aparecen estas lesiones en nuestra población. Método. En este estudio se han descrito de manera prospectiva y durante un período de 12 meses consecutivos los tipos de cáncer cutáneo en los pacientes que acudieron por vez primera a la consulta de Dermatología en el área sanitaria 3 del Servicio Murciano de Salud y las características tanto demográficas como sociales de estos pacientes. Los resultados obtenidos se han analizado mediante el programa SPSS versión 11.5 y se han comparado con los de otros estudios llevados a cabo en otros países. Resultados. Se ha encontrado que los tumores malignos constituyen el tercer motivo primario de consulta más frecuente (16,9 %) y el cuarto motivo secundario de consulta dermatológica (8 %). Los pacientes que acudieron por dicho motivo eran de mayor edad (69,52 años, intervalo de confianza de 95 % [IC 95 %]: 67,82-71,21) que el resto de los sujetos de la muestra (34,52 años, IC 95 %: 33,23-33,81), predominando los varones (51,7 %) frente a las mujeres (48,3 %). Estos individuos poseen un bajo nivel de estudios, que además varía según el tipo de tumor desarrollado, y sus trabajos se efectúan predominantemente al aire libre, con una fotoexposición significativamente más alta (3,35 h/d, IC 95 %: 3,08-3,62) que el resto de pacientes (2,72 h/d, IC 95 %: 2,58-2,86). Además, a medida que aumenta el fototipo disminuye la aparición de tumores malignos de piel. Las lesiones que motivan la consulta al dermatólogo tienen menor tiempo de evolución (11,37 meses, IC 95 %: 7,47-15,26) que la del resto de patología (25,83 meses, IC 95 %: 22,87-28,80), no presentan picos estacionales y el tratamiento que reciben se fundamenta en la cirugía y la crioterapia. Además, estos pacientes se revisan más (84 %) que el resto de pacientes dermatológicos (33 %). Conclusiones. Las lesiones cutáneas malignas o premalignas constituyen un motivo frecuente de consulta dermatológica en el área mediterránea, con unas tasas de frecuentación y un predominio de tipo tumoral diferente al de otros países, probablemente debido al elevado índice de insolación y al fototipo III predominante. Resultaría interesante la realización de estudios similares a nivel nacional (AU)

Introduction. Most epidemiological studies of skin cancer have been performed in countries with very different population and geographic characteristics to Spain. Investigation of this disease in the Spanish population would therefore be of interest. Method. Over a 12-month period, this prospective study recorded the types of skin cancer in consecutive patients who attended a dermatology clinic for the first time in health care area 3 of the health service of the Spanish autonomous community of Murcia. The demographic and social characteristics of these patients were determined. The results obtained were analyzed with the SPSS program, version 11.5, and compared with other studies conducted in other countries. Results. Malignant tumors were the third most common presenting complaint (16.9 %) and the fourth most common secondary complaint (8 %). The patients with skin cancer were older (69.52 years; 95 % confidence interval [CI], 67.82-71.21 years) than the other patients in the sample (34.52 years; 95 % CI, 33.23-33.81 years), and there were more men (51.7 %) than women (48.3 %). These individuals had a low level of schooling, which varied according to the type of tumor, and most had outdoor jobs, with a significantly higher exposure to sunlight (3.35 h/d; 95 % CI, 3.08-3.62 h/d) than the other patients (2.72 h/d; 95 % CI, 2.58-2.86 h/d). Furthermore, fewer malignant cutaneous tumors were found in patients with a higher phototype. The length of time since onset of the presenting complaints was shorter for skin cancer (11.37 months; 95 % CI, 7.47-15.26 months) than for other skin diseases (25.83 months; 95 % CI, 22.87-28.80). Also, there were no seasonal peaks in consultations for skin cancer, and treatment was essentially based on surgery and cryotherapy. In addition, more of these patients had follow-up visits (84 %) than other dermatology patients (33 %). Conclusions. Malignant or premalignant skin lesions are a common presenting skin complaint in the Mediterranean region, with differences in terms of attendance rates and predominant tumor type compared to other countries. This is probably due to the high sun exposure and predominance of skin phototype III. Similar studies for the whole of Spain would be of interest (AU)