Zobrazeno 1 - 10
of 12
pro vyhledávání: '"Mourad Farouk Rezk"'
Autor:
Burkhard Pieper, Mourad Farouk Rezk
Publikováno v:
Advances in Therapy
Immune-mediated inflammatory diseases (IMIDs) are chronic conditions that create a significant disease burden on millions of patients while adding a major financial burden to societies and healthcare systems. The introduction of biologic medicines ha
Autor:
Juyoung Hong, Jae-Woong Hwang, Pia Høier, Shinjung Lee, Hyoung Taek Lim, Bjørn Fehrmann, Jinhan Chung, Mourad Farouk Rezk, Niels Hvorslev, Mette Ottosen, Hans C. Ebbers
Publikováno v:
Biodrugs
Background Biosimilars must meet stringent regulatory requirements, both at the time of authorization and during their lifecycle. Yet it has been suggested that divergence in quality attributes over time may lead to clinically meaningful differences
Autor:
Mourad Farouk Rezk, Burkhard Pieper, Janet Addison, Amine Issa, Hans C. Ebbers, Ulrich Freudensprung
Publikováno v:
Rheumatology and Therapy
Rheumatology and Therapy, Vol 6, Iss 3, Pp 317-338 (2019)
Rheumatology and Therapy, Vol 6, Iss 3, Pp 317-338 (2019)
Introduction In 2016, SB4 (Benepali®) became the first etanercept (ETN) biosimilar to obtain marketing authorisation in Europe. Despite robust analytical and clinical comparisons, outstanding questions remain on SB4 use in routine practice. Methods
Autor:
Carlo Selmi, Klaus Krüger, Alain Cantagrel, Miguel Angel Abad Hernández, Ulrich Freudensprung, Mourad Farouk Rezk, Janet Addison
Publikováno v:
Clinical and experimental rheumatology. 39(2)
The objective of this non-interventional study was to evaluate the effectiveness and safety of the etanercept biosimilar SB4 (BenepaliTM) following transition from reference etanercept in patients with rheumatoid arthritis (RA) or axial spondyloarthr
Autor:
Janet Addison, Abad Hernández, Mourad Farouk Rezk, Klaus Krueger, Carlo Selmi, Ulrich Freudensprung, Alain Cantagrel
Publikováno v:
Poster Presentations.
Background: Having demonstrated bioequivalence and similar efficacy, safety and immunogenicity as the originator, SB4 is approved in the EU as an ETN biosimilar. There is limited evidence on outcomes of transition from originator to biosimilar in a m
Autor:
Burkhard Pieper, Mourad Farouk Rezk
Publikováno v:
Advances in therapy. 35(6)
In addition to the general clinical benefit offered, biosimilars may not only generate savings for healthcare budgets but also improve patient access to biologic products. Since the first biosimilar was approved in Europe in 2006, a further 36 differ
Publikováno v:
Pharmaceutical Research. 33:261-268
As products of living cells, biologics are far more complicated than small molecular-weight drugs not only with respect to size and structural complexity but also their sensitivity to manufacturing processes and post-translational changes. Most of th
Autor:
Mourad Farouk Rezk, Burkhard Pieper
Over the years, biologic agents have proven their importance in the management of chronic autoimmune diseases, such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Biosimilars, which are biologic medicines, are highly similar to a
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cea9c8a4842b6eb16e5294d08e1b28c5
https://europepmc.org/articles/PMC5696297/
https://europepmc.org/articles/PMC5696297/
Autor:
Paul Declerck, Mourad Farouk Rezk
Publikováno v:
Rheumatology (Oxford, England)
Biosimilars are products that contain a similar version of the active substance of an already authorized original biologic medicinal product (reference medicinal product). Their development requires special consideration, as similarity to the referen
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f17a1b583ffeccc6e0eec4d1e4f1826f
https://lirias.kuleuven.be/handle/123456789/603936
https://lirias.kuleuven.be/handle/123456789/603936
Publikováno v:
Rheumatology and Therapy
Introduction Benepali® was the first etanercept (Enbrel®) biosimilar to be approved in the European Union. Both Benepali and Enbrel are available as autoinjector devices. In a recent survey, nurses from France, Germany, Italy, Spain, and the United