Deutsches Psoriasis‐Register PsoBest: Zielsetzung, Methodik und Basisdaten

Augustin, Matthias; Spehr, C.; Radtke, Marc Alexander; Boehncke, Wolf‐Henning; Luger, Thomas A.; Mrowietz, Ulrich; Reusch, Michael; Strömer, Klaus; Wozel, Gottfried; Kiedrowski, Ralph von; Rustenbach, Stephan Jeff; Purwins, Sandra; Reich, Kristian

doi:10.1111/ddg_suppl.12233

Cited by 2 publications

(3 citation statements)

References 16 publications

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“…In order to specifically determine the implications for clinical practice with biosimilars in psoriasis treatment, longitudinal studies are necessary, which has prompted both dermatologists and rheumatologists to require study of biosimilars in long-term registries as per their indications for use [68,81]. An initiative in the respect is the PsoBest, conducted in Germany [82] as well as worldwide, with comparable registries [83,84].…”

Section: Therapies Involving Biological and Biosimilarsmentioning

confidence: 99%

“…EMA guidelines have been developed in relation to the quality of biologicals, stating preclinical and clinical requirements, as well as product specifications [76][77][78][79][80][81][82][83][84][85][86][87][88]. According to EMA guidelines, biosimilars should be deemed specifically different from generics and use of approval procedures for generics is prohibited in relation to biosimilars.…”

Section: Therapies Involving Biological and Biosimilarsmentioning

confidence: 99%

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The Role of Methotrexate in Psoriatic Therapy in the Age of Biologic and Biosimilar Medication: Therapeutic Benefits versus Toxicology Emergencies

Negrei¹,

Boda²

2017

An Interdisciplinary Approach to Psoriasis

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Used in the psoriasis therapy for over 30 years, methotrexate belongs to the non-biological medication class. Its continued use must be studied in the context of the modern unprecedented powerful pharmacological and medical development, due to the particularly, even uniquely fast development of biologicals, which assume an extremely important role in cutting-edge medicine. This status has turned biosimilars and all related matters into an outstanding challenge not only for researchers worldwide but also for other medicinal product-associated fields such as development of regulatory standards and pharmacovigilance, to mention the most important. However, against a comparable high-risk background, compounded by the additional danger of serious cumulative toxicity, methotrexate therapy continues to be recommended mainly for patients suffering from severe psoriasis, seriously affecting their quality of life.

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Section: Therapies Involving Biological and Biosimilarsmentioning

confidence: 99%

Section: Therapies Involving Biological and Biosimilarsmentioning

confidence: 99%

The Role of Methotrexate in Psoriatic Therapy in the Age of Biologic and Biosimilar Medication: Therapeutic Benefits versus Toxicology Emergencies

Negrei¹,

Boda²

2017

An Interdisciplinary Approach to Psoriasis

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“…Dermatologists and rheumatologists are thus correct in demanding that biosimilars be studied in long-term registries according to their indications for use [7,29]. This is being done in Germany with PsoBest [30], and on an international level with comparable registries [31,32].…”

Section: Immunogenicity Of Biosimilarsmentioning

confidence: 99%

Biosimilars in psoriasis: What can we expect?

Radtke

Augustin

2014

J Deutsche Derma Gesell

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SummaryBiosimilars are biotechnologically processed drugs whose amino acid sequence is identical to the original biopharmaceutical. They are of considerable clinical, economical, and health care interest. As patents for biologicals used to treat psoriasis expire, biosimilars will become more and more important within the field of dermatology. The patents for the two top-selling drugs (adalimumab and etanercept) will terminate in the next few years. Applications for biosimilars will presumably be submitted to the EMA and the FDA for all patent-free biologicals. Both regulatory bodies have issued guidelines on the assessment of bioequivalence, as well as the benefits and risks of biosimilars. While the preclinical requirements of the FDA and EMA are largely comparable, the formal requirements for clinical bioequivalence, including clinical efficacy and safety, differ markedly. Therefore, from a medical and health care perspective before biosimilars enter the market, specific evidence-based regulatory conditions need to be created and fulfilled. Only then biosimilars can be a less expensive option for a large number of patients, providing them with substances of the same value. Adequate, unequivocal proof of their bioequivalence, quality, and related patient safety should have priority over any ostensible economic benefits.

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Deutsches Psoriasis‐Register PsoBest: Zielsetzung, Methodik und Basisdaten

Abstract: Patients in PsoBest represent patients with a high burden of disease.

Cited by 2 publications

References 16 publications

The Role of Methotrexate in Psoriatic Therapy in the Age of Biologic and Biosimilar Medication: Therapeutic Benefits versus Toxicology Emergencies

The Role of Methotrexate in Psoriatic Therapy in the Age of Biologic and Biosimilar Medication: Therapeutic Benefits versus Toxicology Emergencies

Biosimilars in psoriasis: What can we expect?

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