Papers by Pedro Acosta-Robles
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Farmacia hospitalaria : órgano oficial de expresión científica de la Sociedad Española de Farmacia Hospitalaria, 2015
According to the European Medicine Agency, a "biosimilar" is a biological medicinal pro... more According to the European Medicine Agency, a "biosimilar" is a biological medicinal product that contains a version of the active substance of an original biological medicinal product (reference or innovative medicinal product) that has been authorized in the European Economic Area. The similarity to the reference medicinal product in terms of quality, biological activity, safety and efficacy needs to be set on a comprehensive comparability basis. The generic standard approach (demonstration of bioequivalence with a reference medicinal product by appropriate bioavailability studies), which is applicable to a wide range of chemically derived medicinal products, is not sufficient to prove the similarity of biotechnology derived products due to their structural complexity. Furthermore, these biopharmaceuticals products, in comparison with the conventional ones, show a greater ability to activate the immune response. The evaluation of biosimilar medicines for authorisation pur...
The Annals of Pharmacotherapy, Nov 1, 2009
TO THE EDITOR: Terbinafine, an allylamine derivative, is an antifungal agent that inhibits ergost... more TO THE EDITOR: Terbinafine, an allylamine derivative, is an antifungal agent that inhibits ergosterol synthesis, destroying the fungal cellular membrane. Acenocoumarol, an anticoagulant agent, has a vitamin K antagonistic effect. Both drugs present high affinity to plasma proteins and are metabolized by cytochrome P450 isoenzymes. In addition, topical terbinafine formulations might present systemic absorption (less than 5%), and the risk of bleeding could be increased when both drugs are combined. 1 Although there is no clinical evidence of interaction between topical terbinafine and coumarins, 2 2 cases with oral terbinafine and warfarin have been reported. 3, 4 We present a case of a possible interaction between topical terbinafine and acenocoumarol.
Annals of Pharmacotherapy, 2009
TO THE EDITOR: Terbinafine, an allylamine derivative, is an antifungal agent that inhibits ergost... more TO THE EDITOR: Terbinafine, an allylamine derivative, is an antifungal agent that inhibits ergosterol synthesis, destroying the fungal cellular membrane. Acenocoumarol, an anticoagulant agent, has a vitamin K antagonistic effect. Both drugs present high affinity to plasma proteins and are metabolized by cytochrome P450 isoenzymes. In addition, topical terbinafine formulations might present systemic absorption (less than 5%), and the risk of bleeding could be increased when both drugs are combined. 1 Although there is no clinical evidence of interaction between topical terbinafine and coumarins, 2 2 cases with oral terbinafine and warfarin have been reported. 3, 4 We present a case of a possible interaction between topical terbinafine and acenocoumarol.
According to the European Medicine Agency, a “biosimilar”
is a biological medicinal product that... more According to the European Medicine Agency, a “biosimilar”
is a biological medicinal product that contains a version of the
active substance of an original biological medicinal product
(reference or innovative medicinal product) that has been au-
thorized in the European Economic Area. The similarity to the
reference medicinal product in terms of quality, biological ac-
tivity, safety and efficacy needs to be set on a comprehensive
comparability basis. The generic standard approach (demons-
tration of bioequivalence with a reference medicinal product
by appropriate bioavailability studies), which is applicable to
a wide range of chemically derived medicinal products, is not
sufficient to prove the similarity of biotechnology derived pro-
ducts due to their structural complexity. Furthermore, these
biopharmaceuticals products, in comparison with the conven-
tional ones, show a greater ability to activate the immune res-
ponse. The evaluation of biosimilar medicines for authorisation
purposes by the European Medicine Agency does not include
recommendations on whether a biosimilar should be used in-
terchangeably with its reference medicine. Substitution policies
are, therefore, within the remit of the EU member states. In
order to support pharmacovigilance monitoring, all appropria-
te measures should be taken to clearly identify any biologi-
cal medicinal product with due regard to its brand name and
batch number. The situation of the European Community and
the regulatory framework have been developed since the first
applications (growth hormone), almost a decade ago, until the
recent advent (monoclonal antibodies). The introduction to the
market of biosimilars have positive effects on competition by
improving access to biological therapies.
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Papers by Pedro Acosta-Robles
is a biological medicinal product that contains a version of the
active substance of an original biological medicinal product
(reference or innovative medicinal product) that has been au-
thorized in the European Economic Area. The similarity to the
reference medicinal product in terms of quality, biological ac-
tivity, safety and efficacy needs to be set on a comprehensive
comparability basis. The generic standard approach (demons-
tration of bioequivalence with a reference medicinal product
by appropriate bioavailability studies), which is applicable to
a wide range of chemically derived medicinal products, is not
sufficient to prove the similarity of biotechnology derived pro-
ducts due to their structural complexity. Furthermore, these
biopharmaceuticals products, in comparison with the conven-
tional ones, show a greater ability to activate the immune res-
ponse. The evaluation of biosimilar medicines for authorisation
purposes by the European Medicine Agency does not include
recommendations on whether a biosimilar should be used in-
terchangeably with its reference medicine. Substitution policies
are, therefore, within the remit of the EU member states. In
order to support pharmacovigilance monitoring, all appropria-
te measures should be taken to clearly identify any biologi-
cal medicinal product with due regard to its brand name and
batch number. The situation of the European Community and
the regulatory framework have been developed since the first
applications (growth hormone), almost a decade ago, until the
recent advent (monoclonal antibodies). The introduction to the
market of biosimilars have positive effects on competition by
improving access to biological therapies.
is a biological medicinal product that contains a version of the
active substance of an original biological medicinal product
(reference or innovative medicinal product) that has been au-
thorized in the European Economic Area. The similarity to the
reference medicinal product in terms of quality, biological ac-
tivity, safety and efficacy needs to be set on a comprehensive
comparability basis. The generic standard approach (demons-
tration of bioequivalence with a reference medicinal product
by appropriate bioavailability studies), which is applicable to
a wide range of chemically derived medicinal products, is not
sufficient to prove the similarity of biotechnology derived pro-
ducts due to their structural complexity. Furthermore, these
biopharmaceuticals products, in comparison with the conven-
tional ones, show a greater ability to activate the immune res-
ponse. The evaluation of biosimilar medicines for authorisation
purposes by the European Medicine Agency does not include
recommendations on whether a biosimilar should be used in-
terchangeably with its reference medicine. Substitution policies
are, therefore, within the remit of the EU member states. In
order to support pharmacovigilance monitoring, all appropria-
te measures should be taken to clearly identify any biologi-
cal medicinal product with due regard to its brand name and
batch number. The situation of the European Community and
the regulatory framework have been developed since the first
applications (growth hormone), almost a decade ago, until the
recent advent (monoclonal antibodies). The introduction to the
market of biosimilars have positive effects on competition by
improving access to biological therapies.