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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Background</span><p id="par0005" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0015"><li class="elsevierStyleListItem" id="lsti0060"><span class="elsevierStyleLabel">&#8211;</span><p id="par0145" class="elsevierStylePara elsevierViewall">The development of biologic therapy has substantially improved the treatment of psoriasis and psoriatic arthritis&#46; At the same time&#44; the elevated cost of biologics has prompted debate on the economic sustainability of the public health system&#46;</p></li><li class="elsevierStyleListItem" id="lsti0065"><span class="elsevierStyleLabel">&#8211;</span><p id="par0150" class="elsevierStylePara elsevierViewall">As patents expire for biologics&#44; business interests and the high capacity of today&#39;s biotechnology industry have encouraged laboratories to develop new drugs&#8212;called biosimilars&#8212;that have effects that resemble those of their reference biologics&#46; In principle&#44; these biosimilars are equal to their reference biologics in efficacy and safety&#44; but they cost less&#46;</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">&#8211;</span><p id="par0020" class="elsevierStylePara elsevierViewall">This attractive theoretical situation&#44; in combination with the influence of parties interested in the business of biologic therapy and the need to curtail public health system spending on this type of drug&#44; has logically fueled a certain amount of debate about biosimilars&#46; Physicians&#44; patients&#44; and the pharmaceutical industry have all taken part&#46; A similar debate took place years ago when generic drugs were introduced&#46;</p></li><li class="elsevierStyleListItem" id="lsti0070"><span class="elsevierStyleLabel">&#8211;</span><p id="par0155" class="elsevierStylePara elsevierViewall">With 2 biosimilars for treating psoriasis and psoriatic arthritis already approved by the European Medicines Agency &#40;EMA&#41; and about to enter the market&#44; this seemed to us to be a good time for dermatologists to state our position on several aspects related to these new drugs&#46;</p></li></ul></p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Considerations</span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Definition</span><p id="par0030" class="elsevierStylePara elsevierViewall">A biosimilar is a biotechnological medicinal product that contains the same active substance as a reference biologic and is prescribed for treating the same disease at the same dose and route of administration&#46; As their name indicates&#44; biosimilars are highly similar to reference biologics&#44; but because of differences in manufacturing processes they are not identical&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Approval</span><p id="par0160" class="elsevierStylePara elsevierViewall">The European Union &#40;EU&#41; approves biosimilars and authorizes their sale following a centralized procedure that upholds the same quality standards that apply to reference biologics and meets the specific requirements and regulations imposed by the EMA regarding manufacturing quality controls&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Biosimilarity</span><p id="par0040" class="elsevierStylePara elsevierViewall">Biosimilarity can be demonstrated by 2 basic conditions&#58; 1&#41; that the biosimilar drug&#39;s structure is highly analogous to that of the reference biologic&#44; a condition that requires the new drug to be characterized through exhaustive analyses&#59; and 2&#41; that the biosimilar&#39;s quality&#44; safety&#44; efficacy and immunogenicity profile is similar to the reference biologic&#39;s&#44; a condition that requires the completion of properly designed clinical trials&#46; Changes in the reference biologic&#39;s manufacturing process can also cause small variations from the original drug and may also make it necessary to run trials to demonstrate comparability in the context of a particular use&#44; followed by extrapolation to other uses&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Indications</span><p id="par0045" class="elsevierStylePara elsevierViewall">A biosimilar has the same indication as its reference biologic&#46; The use we are concerned with in this paper is the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to&#44; are intolerant to&#44; or have a contraindication for other systemic therapies&#44; including cyclosporine&#44; methotrexate&#44; or psoralen plus UV-A therapy&#46; The clinical use of a biosimilar is guided by the same criteria that apply to its reference biologic&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Efficacy</span><p id="par0050" class="elsevierStylePara elsevierViewall">EMA directives state that a biosimilar&#39;s clinical efficacy must be established by a randomized double-blind clinical trial in a population representative of patients with the condition the reference biologic is approved for&#46; The trial must have sufficient power to detect differences between the biosimilar and the biologic&#46; For the 2 infliximab biosimilars recently approved by the EMA &#40;corresponding to CT-P13&#44; developed by Celltrion&#41;&#44; approval was supported by data from clinical trials in patients with rheumatoid arthritis and ankylosing spondylitis&#44; but not specifically in patients with psoriasis&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Extrapolation</span><p id="par0055" class="elsevierStylePara elsevierViewall">Biosimilars can be approved for all or some of the indications the reference biologic is approved for&#44; but not for more indications&#46; Even though the EMA&#39;s recent approval of the 2 infliximab biosimilars is based on efficacy and safety results in patients with rheumatoid arthritis and ankylosing spondylitis&#44; the agency&#39;s European Public Assessment Report lists the same indications approved for infliximab&#46; South Korea&#44; Colombia&#44; Turkey&#44; and Japan have done likewise&#44; whereas the health authorities in Canada have chosen not to include Crohn disease or ulcerative colitis among the extrapolated indications&#46; A trial &#40;NCT02096861&#41; is under way to demonstrate the noninferiority of CT-P13 and evaluate its efficacy in 214 patients with active Crohn disease&#46;</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Safety</span><p id="par0060" class="elsevierStylePara elsevierViewall">The dossier a manufacturer presents to the EMA when applying for approval of a biosimilar must contain data that show that there are no substantial differences between the biosimilar and its reference biologic&#46; Once an approved biosimilar is on the market&#44; it must submit to a pharmacovigilance program that matches in rigor the program set up for the reference biologic&#46; To that end&#44; each drug must be traceable and identifiable at all times so that the possible adverse effects that might be attributed to it can be registered&#46; Therefore&#44; so that a biosimilar given to a patient can be clearly identified&#44; the label should include the common name &#40;international nonproprietary name&#41;&#44; commercial name&#44; and&#47;or the manufacturer&#39;s name&#46;</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Interchangeability and Switchability</span><p id="par0065" class="elsevierStylePara elsevierViewall">The EU does not address the issues of interchangeability or switchability between a reference biologic and a biosimilar&#46; This aspect is left to the judgment of each member state&#46; Regulations in Spain leave the decision to the physician&#58; whereas a pharmacist may switch one manufacturer&#39;s generic drug for another&#39;s&#44; a biosimilar may not be automatically substituted for its reference biologic&#46; The prescribing physician is responsible for the decision&#46;</p></span></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Conclusions</span><p id="par0070" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">1&#46;</span><p id="par0075" class="elsevierStylePara elsevierViewall">The Spanish Academy of Dermatology and Venereology &#40;AEDV&#41; celebrates the incorporation of biosimilars into the treatment regimens for psoriasis and psoriatic arthritis&#46; Thanks to these new drugs&#44; the high cost of biologic therapy is likely to decrease&#44; reinforcing the sustainability of the public health system&#44; a goal the AEDV supports&#46; However&#44; the use of biosimilars should not imply a reduction in therapeutic efficacy&#44; patient safety&#44; or the prescriber&#39;s freedom of choice&#46;</p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">2&#46;</span><p id="par0080" class="elsevierStylePara elsevierViewall">Regarding innovation&#44; biosimilars do not seem to offer advantages over reference biologics&#44; but they do represent savings&#46; Nevertheless&#44; decisions about which drug to prescribe should not be based on economic considerations alone&#44; but rather on scientific evidence&#46; We therefore recommend that dermatologists&#44; pharmacists&#44; managers&#44; and other stakeholders be involved in decisions about how biosimilars are introduced into our health care system&#46;</p></li><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">3&#46;</span><p id="par0085" class="elsevierStylePara elsevierViewall">The AEDV calls for psoriasis and psoriatic arthritis patients to be included in clinical trials of these new drugs to the degree possible&#46; The purpose of such inclusion would be to obtain direct information about efficacy and safety&#44; so that we do not have to extrapolate from findings for other disease contexts&#46; Extrapolations are made to other diseases related to the ones reflected in trials&#44; but these contexts are not necessarily identical with respect to how the biosimilar drug behaves &#40;mechanism of action&#44; dosage&#44; or in possible combinations with other treatments&#41;&#46; If possible&#44; we need clinical trials for indications in which the difference in efficacy between the drug and placebo is greatest&#58; such is the case in psoriasis in comparison to rheumatoid arthritis&#46;</p></li><li class="elsevierStyleListItem" id="lsti0040"><span class="elsevierStyleLabel">4&#46;</span><p id="par0090" class="elsevierStylePara elsevierViewall">Once the biosimilar is on the market&#44; both the new drug and its reference biologic should become available to prescribing dermatologists in hospitals&#46; The physician will take responsibility for choosing to prescribe a biosimilar&#44; and the choice must be guided by the same criteria applied to the clinical use of the biologic&#46;</p></li><li class="elsevierStyleListItem" id="lsti0075"><span class="elsevierStyleLabel">5&#46;</span><p id="par0165" class="elsevierStylePara elsevierViewall">We believe that the decision to prescribe a biosimilar should be assessed on a case-by-case basis and that the patient must agree with the choice&#46; Switching from a biologic to a biosimilar should also be decided by the physician with the patient&#39;s consent&#46;</p></li><li class="elsevierStyleListItem" id="lsti0050"><span class="elsevierStyleLabel">6&#46;</span><p id="par0100" class="elsevierStylePara elsevierViewall">Given that it is impossible to absolutely establish that a biosimilar and a reference biologic are identical&#44; even slight differences between them might have clinical consequences&#46; Therefore&#44; information about the true efficacy and safety of biosimilars in the treatment of psoriasis and psoriatic arthritis must be confirmed afterwards&#44; once biosimilars are on the market and in use and once the relevant pharmacovigilance data are being registered&#46;</p></li><li class="elsevierStyleListItem" id="lsti0055"><span class="elsevierStyleLabel">7&#46;</span><p id="par0105" class="elsevierStylePara elsevierViewall">Biosimilars on the market should come with patient and prescriber information that is clear and precise&#44; so that prescriber and patient can make proper decisions about the acceptability of these drugs&#46; Given the doubts that this new concept of biosimilarity may arouse among both dermatologists and users&#44; we must take steps to inform and teach those concerned&#46; Ideally information should reflect consensus formed before these new drugs are used routinely&#46; The AEDV is willing to collaborate with other parties to achieve that goal&#46;</p></li><li class="elsevierStyleListItem" id="lsti0080"><span class="elsevierStyleLabel">8&#46;</span><p id="par0170" class="elsevierStylePara elsevierViewall">The opinions we hold about biosimilars today may change in the light of the experience that will come after commercialization and&#47;or the publication of new trails&#46;</p></li></ul></p><p id="par0115" class="elsevierStylePara elsevierViewall">Date of final review&#58; November 2014</p></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0060">Conflicts of Interest</span><p id="par0120" class="elsevierStylePara elsevierViewall">Dr G&#46; Carretero Hern&#225;ndez has participated in clinical trials and postapproval studies sponsored or funded by Abbvie&#44; Celgene&#44; Janssen&#44; Lilly&#44; MSD&#44; Novartis&#44; and Pfizer&#46; He has received consultancy or speaker&#39;s fees from Abbvie&#44; Celgene&#44; Janssen&#44; MSD&#44; Novartis&#44; Pfizer&#44; and Leo&#46;</p><p id="par0125" class="elsevierStylePara elsevierViewall">Dr L&#46; Puig Sanz has participated in clinical trials and postapproval studies sponsored or funded by Abbvie&#44; Amgen&#44; Janssen&#44; Lilly&#44; MSD&#44; Novartis&#44; and Pfizer&#46; He has received consultancy or speaker&#39;s fees from Amgen&#44; Abbvie&#44; Janssen&#44; Lilly&#44; Merck Serono&#44; MSD&#44; Novartis&#44; Pfizer&#44; and Leo&#46;</p></span></span>"
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Opinion Article
The Use of Biosimilar Drugs in Psoriasis: A Position Paper
Fármacos biosimilares en psoriasis: informe de posicionamiento
G. Carretero Hernándeza,
Corresponding author
gcarreteroh58@gmail.com

Corresponding author.
, L. Puigb, en representación del Grupo de Psoriasis de la AEDV
a Coordinador del Grupo de Trabajo de Psoriasis de la AEDV
b Ex-coordinador del Grupo de Trabajo de Psoriasis de la AEDV
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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Background</span><p id="par0005" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0015"><li class="elsevierStyleListItem" id="lsti0060"><span class="elsevierStyleLabel">&#8211;</span><p id="par0145" class="elsevierStylePara elsevierViewall">The development of biologic therapy has substantially improved the treatment of psoriasis and psoriatic arthritis&#46; At the same time&#44; the elevated cost of biologics has prompted debate on the economic sustainability of the public health system&#46;</p></li><li class="elsevierStyleListItem" id="lsti0065"><span class="elsevierStyleLabel">&#8211;</span><p id="par0150" class="elsevierStylePara elsevierViewall">As patents expire for biologics&#44; business interests and the high capacity of today&#39;s biotechnology industry have encouraged laboratories to develop new drugs&#8212;called biosimilars&#8212;that have effects that resemble those of their reference biologics&#46; In principle&#44; these biosimilars are equal to their reference biologics in efficacy and safety&#44; but they cost less&#46;</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">&#8211;</span><p id="par0020" class="elsevierStylePara elsevierViewall">This attractive theoretical situation&#44; in combination with the influence of parties interested in the business of biologic therapy and the need to curtail public health system spending on this type of drug&#44; has logically fueled a certain amount of debate about biosimilars&#46; Physicians&#44; patients&#44; and the pharmaceutical industry have all taken part&#46; A similar debate took place years ago when generic drugs were introduced&#46;</p></li><li class="elsevierStyleListItem" id="lsti0070"><span class="elsevierStyleLabel">&#8211;</span><p id="par0155" class="elsevierStylePara elsevierViewall">With 2 biosimilars for treating psoriasis and psoriatic arthritis already approved by the European Medicines Agency &#40;EMA&#41; and about to enter the market&#44; this seemed to us to be a good time for dermatologists to state our position on several aspects related to these new drugs&#46;</p></li></ul></p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Considerations</span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Definition</span><p id="par0030" class="elsevierStylePara elsevierViewall">A biosimilar is a biotechnological medicinal product that contains the same active substance as a reference biologic and is prescribed for treating the same disease at the same dose and route of administration&#46; As their name indicates&#44; biosimilars are highly similar to reference biologics&#44; but because of differences in manufacturing processes they are not identical&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Approval</span><p id="par0160" class="elsevierStylePara elsevierViewall">The European Union &#40;EU&#41; approves biosimilars and authorizes their sale following a centralized procedure that upholds the same quality standards that apply to reference biologics and meets the specific requirements and regulations imposed by the EMA regarding manufacturing quality controls&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Biosimilarity</span><p id="par0040" class="elsevierStylePara elsevierViewall">Biosimilarity can be demonstrated by 2 basic conditions&#58; 1&#41; that the biosimilar drug&#39;s structure is highly analogous to that of the reference biologic&#44; a condition that requires the new drug to be characterized through exhaustive analyses&#59; and 2&#41; that the biosimilar&#39;s quality&#44; safety&#44; efficacy and immunogenicity profile is similar to the reference biologic&#39;s&#44; a condition that requires the completion of properly designed clinical trials&#46; Changes in the reference biologic&#39;s manufacturing process can also cause small variations from the original drug and may also make it necessary to run trials to demonstrate comparability in the context of a particular use&#44; followed by extrapolation to other uses&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Indications</span><p id="par0045" class="elsevierStylePara elsevierViewall">A biosimilar has the same indication as its reference biologic&#46; The use we are concerned with in this paper is the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to&#44; are intolerant to&#44; or have a contraindication for other systemic therapies&#44; including cyclosporine&#44; methotrexate&#44; or psoralen plus UV-A therapy&#46; The clinical use of a biosimilar is guided by the same criteria that apply to its reference biologic&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Efficacy</span><p id="par0050" class="elsevierStylePara elsevierViewall">EMA directives state that a biosimilar&#39;s clinical efficacy must be established by a randomized double-blind clinical trial in a population representative of patients with the condition the reference biologic is approved for&#46; The trial must have sufficient power to detect differences between the biosimilar and the biologic&#46; For the 2 infliximab biosimilars recently approved by the EMA &#40;corresponding to CT-P13&#44; developed by Celltrion&#41;&#44; approval was supported by data from clinical trials in patients with rheumatoid arthritis and ankylosing spondylitis&#44; but not specifically in patients with psoriasis&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Extrapolation</span><p id="par0055" class="elsevierStylePara elsevierViewall">Biosimilars can be approved for all or some of the indications the reference biologic is approved for&#44; but not for more indications&#46; Even though the EMA&#39;s recent approval of the 2 infliximab biosimilars is based on efficacy and safety results in patients with rheumatoid arthritis and ankylosing spondylitis&#44; the agency&#39;s European Public Assessment Report lists the same indications approved for infliximab&#46; South Korea&#44; Colombia&#44; Turkey&#44; and Japan have done likewise&#44; whereas the health authorities in Canada have chosen not to include Crohn disease or ulcerative colitis among the extrapolated indications&#46; A trial &#40;NCT02096861&#41; is under way to demonstrate the noninferiority of CT-P13 and evaluate its efficacy in 214 patients with active Crohn disease&#46;</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Safety</span><p id="par0060" class="elsevierStylePara elsevierViewall">The dossier a manufacturer presents to the EMA when applying for approval of a biosimilar must contain data that show that there are no substantial differences between the biosimilar and its reference biologic&#46; Once an approved biosimilar is on the market&#44; it must submit to a pharmacovigilance program that matches in rigor the program set up for the reference biologic&#46; To that end&#44; each drug must be traceable and identifiable at all times so that the possible adverse effects that might be attributed to it can be registered&#46; Therefore&#44; so that a biosimilar given to a patient can be clearly identified&#44; the label should include the common name &#40;international nonproprietary name&#41;&#44; commercial name&#44; and&#47;or the manufacturer&#39;s name&#46;</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Interchangeability and Switchability</span><p id="par0065" class="elsevierStylePara elsevierViewall">The EU does not address the issues of interchangeability or switchability between a reference biologic and a biosimilar&#46; This aspect is left to the judgment of each member state&#46; Regulations in Spain leave the decision to the physician&#58; whereas a pharmacist may switch one manufacturer&#39;s generic drug for another&#39;s&#44; a biosimilar may not be automatically substituted for its reference biologic&#46; The prescribing physician is responsible for the decision&#46;</p></span></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Conclusions</span><p id="par0070" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">1&#46;</span><p id="par0075" class="elsevierStylePara elsevierViewall">The Spanish Academy of Dermatology and Venereology &#40;AEDV&#41; celebrates the incorporation of biosimilars into the treatment regimens for psoriasis and psoriatic arthritis&#46; Thanks to these new drugs&#44; the high cost of biologic therapy is likely to decrease&#44; reinforcing the sustainability of the public health system&#44; a goal the AEDV supports&#46; However&#44; the use of biosimilars should not imply a reduction in therapeutic efficacy&#44; patient safety&#44; or the prescriber&#39;s freedom of choice&#46;</p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">2&#46;</span><p id="par0080" class="elsevierStylePara elsevierViewall">Regarding innovation&#44; biosimilars do not seem to offer advantages over reference biologics&#44; but they do represent savings&#46; Nevertheless&#44; decisions about which drug to prescribe should not be based on economic considerations alone&#44; but rather on scientific evidence&#46; We therefore recommend that dermatologists&#44; pharmacists&#44; managers&#44; and other stakeholders be involved in decisions about how biosimilars are introduced into our health care system&#46;</p></li><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">3&#46;</span><p id="par0085" class="elsevierStylePara elsevierViewall">The AEDV calls for psoriasis and psoriatic arthritis patients to be included in clinical trials of these new drugs to the degree possible&#46; The purpose of such inclusion would be to obtain direct information about efficacy and safety&#44; so that we do not have to extrapolate from findings for other disease contexts&#46; Extrapolations are made to other diseases related to the ones reflected in trials&#44; but these contexts are not necessarily identical with respect to how the biosimilar drug behaves &#40;mechanism of action&#44; dosage&#44; or in possible combinations with other treatments&#41;&#46; If possible&#44; we need clinical trials for indications in which the difference in efficacy between the drug and placebo is greatest&#58; such is the case in psoriasis in comparison to rheumatoid arthritis&#46;</p></li><li class="elsevierStyleListItem" id="lsti0040"><span class="elsevierStyleLabel">4&#46;</span><p id="par0090" class="elsevierStylePara elsevierViewall">Once the biosimilar is on the market&#44; both the new drug and its reference biologic should become available to prescribing dermatologists in hospitals&#46; The physician will take responsibility for choosing to prescribe a biosimilar&#44; and the choice must be guided by the same criteria applied to the clinical use of the biologic&#46;</p></li><li class="elsevierStyleListItem" id="lsti0075"><span class="elsevierStyleLabel">5&#46;</span><p id="par0165" class="elsevierStylePara elsevierViewall">We believe that the decision to prescribe a biosimilar should be assessed on a case-by-case basis and that the patient must agree with the choice&#46; Switching from a biologic to a biosimilar should also be decided by the physician with the patient&#39;s consent&#46;</p></li><li class="elsevierStyleListItem" id="lsti0050"><span class="elsevierStyleLabel">6&#46;</span><p id="par0100" class="elsevierStylePara elsevierViewall">Given that it is impossible to absolutely establish that a biosimilar and a reference biologic are identical&#44; even slight differences between them might have clinical consequences&#46; Therefore&#44; information about the true efficacy and safety of biosimilars in the treatment of psoriasis and psoriatic arthritis must be confirmed afterwards&#44; once biosimilars are on the market and in use and once the relevant pharmacovigilance data are being registered&#46;</p></li><li class="elsevierStyleListItem" id="lsti0055"><span class="elsevierStyleLabel">7&#46;</span><p id="par0105" class="elsevierStylePara elsevierViewall">Biosimilars on the market should come with patient and prescriber information that is clear and precise&#44; so that prescriber and patient can make proper decisions about the acceptability of these drugs&#46; Given the doubts that this new concept of biosimilarity may arouse among both dermatologists and users&#44; we must take steps to inform and teach those concerned&#46; Ideally information should reflect consensus formed before these new drugs are used routinely&#46; The AEDV is willing to collaborate with other parties to achieve that goal&#46;</p></li><li class="elsevierStyleListItem" id="lsti0080"><span class="elsevierStyleLabel">8&#46;</span><p id="par0170" class="elsevierStylePara elsevierViewall">The opinions we hold about biosimilars today may change in the light of the experience that will come after commercialization and&#47;or the publication of new trails&#46;</p></li></ul></p><p id="par0115" class="elsevierStylePara elsevierViewall">Date of final review&#58; November 2014</p></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0060">Conflicts of Interest</span><p id="par0120" class="elsevierStylePara elsevierViewall">Dr G&#46; Carretero Hern&#225;ndez has participated in clinical trials and postapproval studies sponsored or funded by Abbvie&#44; Celgene&#44; Janssen&#44; Lilly&#44; MSD&#44; Novartis&#44; and Pfizer&#46; He has received consultancy or speaker&#39;s fees from Abbvie&#44; Celgene&#44; Janssen&#44; MSD&#44; Novartis&#44; Pfizer&#44; and Leo&#46;</p><p id="par0125" class="elsevierStylePara elsevierViewall">Dr L&#46; Puig Sanz has participated in clinical trials and postapproval studies sponsored or funded by Abbvie&#44; Amgen&#44; Janssen&#44; Lilly&#44; MSD&#44; Novartis&#44; and Pfizer&#46; He has received consultancy or speaker&#39;s fees from Amgen&#44; Abbvie&#44; Janssen&#44; Lilly&#44; Merck Serono&#44; MSD&#44; Novartis&#44; Pfizer&#44; and Leo&#46;</p></span></span>"
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Article information
ISSN: 15782190
Original language: English
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Idiomas
Actas Dermo-Sifiliográficas
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