Author "Perez Rodriguez, Violeta"

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1. Regulatory challenges with biosimilars: an update from 20 countries [2021]

  • Kang, Hye-Na, Thorpe, Robin, Knezevic, Ivana, Casas Levano, Mary, Chilufya, Mumbi Bernice, Chirachanakul, Parichard, Chua, Hui Ming, Dalili, Dina, Foo, Freddie, Gao, Kai, Habahbeh, Suna, Hamel, Hugo, Kim, Gi Hyun, Perez Rodriguez, Violeta, Putri, Desi Eka, Rodgers, Jacqueline, Savkina, Maria, Semeniuk, Oleh, Srivastava, Shraddha, Tavares Neto, Joao, Wadhwa, Meenu, and Yamaguchi, Teruhide
  • Annals of the New York Academy of Sciences. May 2021, Vol. 1491 Issue 1, p42, 18 p.

2. The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019 [2020]

  • Blades, Carolina Damas Rocha Zarate, Casas Levano, Mary, Chew, Jing Yin, Chilufya, Mumbi Bernice, Chirachanakul, Parichard, Chua, Hui Ming, Farahani, Ali Vasheghani, Ghobrial, Mariam Raouf Wefky, Habahbeh, Suna, Hamel, Hugo, Kim, Gi Hyun, Perez Rodriguez, Violeta, Putri, Desi Eka, Rodgers, Jacqueline, Savkina, Maria, Semeniuk, Oleh, Srivastava, Shraddha, Wadhwa, Meenu, Yamaguchi, Teruhide, Kang, Hye-Na, Thorpe, Robin, and Knezevic, Ivana
  • In Biologicals May 2020 65:1-9

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4. The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019 [2020]

  • Kang, Hye-Na, Thorpe, Robin, Knezevic, Ivana, Blades, Carolina Damas Rocha Zarate, Casas Levano, Mary, Chew, Jing Yin, Chilufya, Mumbi Bernice, Chirachanakul, Parichard, Chua, Hui Ming, Farahani, Ali Vasheghani, Ghobrial, Mariam Raouf Wefky, Habahbeh, Suna, Hamel, Hugo, Kim, Gi Hyun, Perez Rodriguez, Violeta, Putri, Desi Eka, Rodgers, Jacqueline, Savkina, Maria, Semeniuk, Oleh, Srivastava, Shraddha, Wadhwa, Meenu, and Yamaguchi, Teruhide
  • Biologicals. May 2020, Vol. 65, 1

5. The role of environmental influences in the complex relationship between borderline personality disorder and attention-deficit/hyperactivity disorder: review of recent findings [2020]

  • Calvo, Natalia, Lara, Benjamin, Serrat, Laia, Perez-Rodriguez, Violeta, Andion, Ascar, Ramos-Quiroga, Josep A., and Ferrer, Marc
  • Borderline Personality Disorder and Emotion Dysregulation. Jan 6, 2020, Vol. 7 Issue 1

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7. The regulatory framework for similar biotherapeutic products in Cuba [2011]

  • Hechavarría Núñez, Yanet, Pérez Massipe, Rodrigo Omar, Orta Hernández, Santa Deybis, Muñoz, Lázara Martínez, Jacobo Casanueva, Olga Lidia, Pérez Rodríguez, Violeta, Domínguez Morales, Rolando Bárbaro, and Pérez Cristiá, Rafael B.
  • In Biologicals September 2011 39(5):317-320

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11. regulatory framework for similar biotherapeutic products in Cuba [2011]

  • Hechavarría Núñez, Yanet, Pérez Massipe, Rodrigo Omar, Orta Hernández, Santa Deybis, Muñoz, Lázara Martínez, Jacobo Casanueva, Olga Lidia, Pérez Rodríguez, Violeta, Domínguez Morales, Rolando Bárbaro, and Pérez Cristiá, Rafael B.
  • Biologicals, 2011 Sept., v. 39, no. 5, p. 317-320.
Subjects
marketing costs, guidelines, arthritis, quality control, new products, biopharmaceuticals, and biopharmaceutical industry
Abstract
Biopharmaceuticals make up a significant proportion of medicinal products used for the treatment of diseases such as cancer, arthritis, cardiac dysfunctions and AIDS. Access to therapies based on the use of these products has been limited as a result of the high marketing costs. Cuba has a biopharmaceutical industry with great potential for innovation, capable of developing new products and to produce others, like the biosimilars destined to fulfill the needs of its National Health System. The Center for State Control on the Quality of Drugs (CECMED) the Cuban NRA, is facing the challenge of regulating the approval of biosimilar products manufactured locally. Consequently, CECMED has issued a position paper establishing the basic principles for regulation of these products and a specific guideline on this was elaborated.

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