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Article ; Online: Biosimilars.

Edwards, Christopher J / Bellinvia, Salvatore

2020 Volume 29, Issue 6, Page(s) 525–532

MeSH term(s)	Antibodies, Monoclonal, Humanized/therapeutic use ; Biosimilar Pharmaceuticals/therapeutic use ; Clinical Trials, Phase III as Topic ; Drug Approval ; Drug Development ; Humans ; Lupus Erythematosus, Systemic/drug therapy ; Lupus Erythematosus, Systemic/economics ; Rituximab/therapeutic use
Chemical Substances	Antibodies, Monoclonal, Humanized ; Biosimilar Pharmaceuticals ; Rituximab (4F4X42SYQ6) ; belimumab (73B0K5S26A)
Language	English
Publishing date	2020-03-18
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	1154407-7
ISSN	1477-0962 ; 0961-2033
ISSN (online)	1477-0962
ISSN	0961-2033
DOI	10.1177/0961203320910797
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Article ; Online: Explaining biosimilars and how reverse engineering plays a critical role in their development.

Bellinvia, Salvatore / Edwards, Christopher J

Expert opinion on drug discovery

2020 Volume 15, Issue 11, Page(s) 1283–1289

Abstract: Introduction: Biologicals are protein-based therapeutics consisting of larger and more complex structures than small molecule medicines. As the patents for originator biological therapeutics expire, biosimilar products are licensed for the same ... ...

Abstract	Introduction: Biologicals are protein-based therapeutics consisting of larger and more complex structures than small molecule medicines. As the patents for originator biological therapeutics expire, biosimilar products are licensed for the same indications as their marketed reference biologics across different specialities. Owing to the complex nature of the manufacturing process for a biological therapy compared to conventional chemically synthetized medicines, the development of biosimilars is more complicated and costly than the manufacture of generic small molecules. Areas covered: The manufacturing process of the originator biologic is in most cases largely unknown to biosimilar developers and therefore reverse engineering through extensive analysis of the originator is a fundamental and critical step for successful biosimilar development. In this review, the authors examine the abbreviated roadmap for biosimilar approval which must be underpinned by the same rigorous standards that apply to all biological medicines. They discuss various aspects of biosimilar manufacturing with a focus on reverse engineering. Expert opinion: The biosimilar approval pathway places a greater emphasis on preclinical assessments in comparison to the development of originator biologics. Multiple comparative clinical studies add little to the confirmation of the efficacy of the molecule under study whilst adding considerably to the cost and time of bringing a biosimilar into clinical use. A successful demonstration of biosimilarity to the reference product is therefore essential at a structural and functional level but this could not be achieved without well-designed and quality-driven reverse engineering of the originator production process.
MeSH term(s)	Animals ; Biological Products/administration & dosage ; Biological Products/pharmacology ; Biosimilar Pharmaceuticals/administration & dosage ; Biosimilar Pharmaceuticals/pharmacology ; Drug Approval ; Drug Development ; Humans
Chemical Substances	Biological Products ; Biosimilar Pharmaceuticals
Language	English
Publishing date	2020-07-27
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2259618-5
ISSN	1746-045X ; 1746-0441
ISSN (online)	1746-045X
ISSN	1746-0441
DOI	10.1080/17460441.2020.1796627
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Article ; Online: Inhomogeneous Diastereomeric Composition of Mongersen Antisense Phosphorothioate Oligonucleotide Preparations and Related Pharmacological Activity Impairment.

Arrico, Lorenzo / Stolfi, Carmine / Marafini, Irene / Monteleone, Giovanni / Demartis, Salvatore / Bellinvia, Salvatore / Viti, Francesca / McNulty, Marie / Cabani, Irene / Falezza, Anita / Di Bari, Lorenzo

Nucleic acid therapeutics

2022 Volume 32, Issue 4, Page(s) 312–320

Abstract: Mongersen is a 21-mer antisense oligonucleotide designed to downregulate Mothers against decapentaplegic homolog 7 (SMAD7) expression to treat Crohn's disease. Mongersen was manufactured in numerous batches at different scales during several years of ... ...

Abstract	Mongersen is a 21-mer antisense oligonucleotide designed to downregulate Mothers against decapentaplegic homolog 7 (SMAD7) expression to treat Crohn's disease. Mongersen was manufactured in numerous batches at different scales during several years of clinical development, which all appeared identical, using common physicochemical analytical techniques, while only phosphorous-31 nuclear magnetic resonance (
MeSH term(s)	Crohn Disease/drug therapy ; Crohn Disease/metabolism ; Down-Regulation ; Humans ; Oligonucleotides ; Oligonucleotides, Antisense/pharmacology ; Phosphorothioate Oligonucleotides/chemistry
Chemical Substances	Oligonucleotides ; Oligonucleotides, Antisense ; Phosphorothioate Oligonucleotides ; GED0301 (O1VIU3R1NE)
Language	English
Publishing date	2022-03-09
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2639888-6
ISSN	2159-3345 ; 2159-3337
ISSN (online)	2159-3345
ISSN	2159-3337
DOI	10.1089/nat.2021.0089
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Article ; Online: A review article on biosimilar infliximab SB2 in the treatment of rheumatoid arthritis.

Bellinvia, Salvatore / Ashraf, Madiha / Polosa, Riccardo / Edwards, Christopher

Immunotherapy

2017 Volume 9, Issue 14, Page(s) 1133–1142

Abstract: TNF inhibition has had a major impact as an approach for treating rheumatoid arthritis and a series of biologic agents directed against TNF have been developed for clinical use. Infliximab, a chimeric monoclonal antibody against soluble and membrane- ... ...

Abstract	TNF inhibition has had a major impact as an approach for treating rheumatoid arthritis and a series of biologic agents directed against TNF have been developed for clinical use. Infliximab, a chimeric monoclonal antibody against soluble and membrane-bound TNF-α, was the biopharmaceutical to lead this 'biologics revolution'. However, with expiration of patent protection of the originator medicinal product, biosimilar versions of infliximab have been developed through biosimilarity studies and randomized controlled trials aiming to assess pharmacokinetic, pharmacodynamic and clinical equivalence to their originator (reference product) in patients with moderate-to-severe disease activity. This review summarizes the clinical development of SB2, a biosimilar of infliximab, in rheumatoid arthritis.
Language	English
Publishing date	2017-11
Publishing country	England
Document type	Journal Article
ISSN	1750-7448
ISSN (online)	1750-7448
DOI	10.2217/imt-2017-0068
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Article ; Online: The unleashing of the immune system in COVID-19 and sepsis: the calm before the storm?

Bellinvia, Salvatore / Edwards, Christopher J / Schisano, Matteo / Banfi, Paolo / Fallico, Matteo / Murabito, Paolo

Inflammation research : official journal of the European Histamine Research Society ... [et al.

2020 Volume 69, Issue 8, Page(s) 757–763

Abstract: The novel coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is sorely testing health care systems and economies around the world and is rightly considered as the major health emergency in ... ...

Abstract	The novel coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is sorely testing health care systems and economies around the world and is rightly considered as the major health emergency in a century. Despite the course of the disease appearing to be mild in many cases, a significant proportion of symptomatic patients develop pneumonia requiring hospitalisation or progress to manifest respiratory complications leading to intensive care treatment. Potential interventions for SARS-CoV2-associated pneumonia are being tested, some of which holding promise, but as of today none of these has yet demonstrated outstanding efficacy in treating COVID-19. In this article, we discuss fresh perspectives and insights into the potential role of immune dysregulation in COVID-19 as well as similarities with systemic inflammatory response in sepsis and the rationale for exploring novel treatment options affecting host immune response.
MeSH term(s)	Betacoronavirus ; Biomarkers ; COVID-19 ; Coronavirus Infections/complications ; Coronavirus Infections/diagnosis ; Coronavirus Infections/immunology ; Coronavirus Infections/therapy ; Cytokine Release Syndrome/virology ; Cytokines/immunology ; Humans ; Immune System/virology ; Immunity, Innate ; Inflammation ; Pandemics ; Pneumonia, Viral/complications ; Pneumonia, Viral/diagnosis ; Pneumonia, Viral/immunology ; Pneumonia, Viral/therapy ; SARS-CoV-2 ; Sepsis/complications ; Sepsis/diagnosis ; Sepsis/immunology ; Sepsis/therapy
Chemical Substances	Biomarkers ; Cytokines
Keywords	covid19
Language	English
Publishing date	2020-05-28
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	1221794-3
ISSN	1420-908X ; 1023-3830
ISSN (online)	1420-908X
ISSN	1023-3830
DOI	10.1007/s00011-020-01366-6
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Article ; Online: Can we wean patients with inflammatory arthritis from biological therapies?

Edwards, Christopher J / Galeazzi, Mauro / Bellinvia, Salvatore / Ringer, Ariana / Dimitroulas, Theodoros / Kitas, George

Autoimmunity reviews

2019 Volume 18, Issue 12, Page(s) 102399

Abstract: Biological therapies have represented a cornerstone in the treatment of immune-mediated inflammatory diseases. Their advent combined with implementation of a treat-to-target approach has meant that remission or low disease activity are now realistic ... ...

Abstract	Biological therapies have represented a cornerstone in the treatment of immune-mediated inflammatory diseases. Their advent combined with implementation of a treat-to-target approach has meant that remission or low disease activity are now realistic targets for treatment achieved by a significant number of patients. However, biologicals are not risk free and their elevated costs continue to present an important economic burden to national healthcare services. "Can we wean patients with inflammatory arthritis from biological therapies?" Over the last decade this question has become increasingly important as to define the best management strategies in terms of efficacy, safety and economic outcomes. Not surprisingly this has generated an interesting debate as to whether reasons to taper biologics outweigh reasons not to taper and evidence in support of either of these schools of thought is persistently growing. AIM: In this article we reviewed the contents of the relevant session from the 2019 Controversies in Rheumatology and Autoimmunity meeting in Florence.
MeSH term(s)	Antirheumatic Agents/therapeutic use ; Arthritis, Rheumatoid/drug therapy ; Humans
Chemical Substances	Antirheumatic Agents
Language	English
Publishing date	2019-10-19
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	2144145-5
ISSN	1873-0183 ; 1568-9972
ISSN (online)	1873-0183
ISSN	1568-9972
DOI	10.1016/j.autrev.2019.102399
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Article ; Online: Adalimumab Biosimilars in Europe: An Overview of the Clinical Evidence.

Bellinvia, Salvatore / Cummings, J R Fraser / Ardern-Jones, Michael R / Edwards, Christopher J

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy

2019 Volume 33, Issue 3, Page(s) 241–253

Abstract: Adalimumab, the first fully humanised monoclonal antibody against tumour necrosis factor alpha (TNF-α), has played a leading role in the revolution brought about by the introduction of biologics, and has received the widest range of indications among TNF- ...

Abstract	Adalimumab, the first fully humanised monoclonal antibody against tumour necrosis factor alpha (TNF-α), has played a leading role in the revolution brought about by the introduction of biologics, and has received the widest range of indications among TNF-α inhibitors. Post-registration, observational and registry studies of real-life use have largely supported the outcomes seen in registrational clinical trials. With the recent loss of exclusivity for the originator medicinal product in Europe, a number of biosimilar adalimumab molecules have been licensed for use in the same indications as the originator molecule across rheumatology, dermatology, gastroenterology and ophthalmology. Clinicians in these areas first gained experience with biosimilar infliximab, followed by etanercept and rituximab. However, adalimumab is likely to present unique challenges given the numbers of patients treated and the range of biosimilar adalimumab products available. The biosimilar approval pathway has an emphasis on the pre-clinical analytic data in combination with clinical studies conducted to confirm therapeutic equivalence. To date, several adalimumab biosimilars have entered the EU market following successful marketing authorisation applications and recent expiration of originator patent protection. This overview covers the extent of use of adalimumab and summarises the regulatory process involved in the development of biosimilars as well as their use in clinical practice. The authors also discuss clinical data available so far on adalimumab biosimilars and their envisaged impact in the field of immune-mediated inflammatory diseases.
MeSH term(s)	Adalimumab/therapeutic use ; Biosimilar Pharmaceuticals/therapeutic use ; Etanercept/therapeutic use ; Europe ; Humans ; Infliximab/therapeutic use ; Rituximab/therapeutic use ; Therapeutic Equivalency
Chemical Substances	Biosimilar Pharmaceuticals ; Rituximab (4F4X42SYQ6) ; Infliximab (B72HH48FLU) ; Adalimumab (FYS6T7F842) ; Etanercept (OP401G7OJC)
Language	English
Publishing date	2019-05-20
Publishing country	New Zealand
Document type	Journal Article ; Review
ZDB-ID	1364202-9
ISSN	1179-190X ; 1173-8804
ISSN (online)	1179-190X
ISSN	1173-8804
DOI	10.1007/s40259-019-00355-4
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Article ; Online: The unleashing of the immune system in COVID-19 and sepsis

Bellinvia, Salvatore / Edwards, Christopher J. / Schisano, Matteo / Banfi, Paolo / Fallico, Matteo / Murabito, Paolo

Inflammation Research

the calm before the storm?

2020 Volume 69, Issue 8, Page(s) 757–763

Keywords	Immunology ; Pharmacology ; covid19
Language	English
Publisher	Springer Science and Business Media LLC
Publishing country	us
Document type	Article ; Online
ZDB-ID	1221794-3
ISSN	1420-908X ; 1023-3830
ISSN (online)	1420-908X
ISSN	1023-3830
DOI	10.1007/s00011-020-01366-6
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Article: The unleashing of the immune system in COVID-19 and sepsis: the calm before the storm?

Bellinvia, Salvatore / Edwards, Christopher J / Schisano, Matteo / Banfi, Paolo / Fallico, Matteo / Murabito, Paolo

Inflamm Res

Abstract	The novel coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is sorely testing health care systems and economies around the world and is rightly considered as the major health emergency in a century. Despite the course of the disease appearing to be mild in many cases, a significant proportion of symptomatic patients develop pneumonia requiring hospitalisation or progress to manifest respiratory complications leading to intensive care treatment. Potential interventions for SARS-CoV2-associated pneumonia are being tested, some of which holding promise, but as of today none of these has yet demonstrated outstanding efficacy in treating COVID-19. In this article, we discuss fresh perspectives and insights into the potential role of immune dysregulation in COVID-19 as well as similarities with systemic inflammatory response in sepsis and the rationale for exploring novel treatment options affecting host immune response.
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #401592
Database	COVID19

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Article ; Online: Necrotizing Panniculitis as an Uncommon Manifestation of Acute Pancreatitis.

Bruno, Cosimo Marcello / Pricoco, Gabriele Sebastiano / Bellinvia, Salvatore / Amaradio, Maria Domenica / Cantone, Damiano / Polosa, Riccardo

European journal of case reports in internal medicine

2017 Volume 4, Issue 3, Page(s) 540

Abstract: Pancreatic panniculitis is a rare disorder affecting 2-3% of patients with pancreatic disease. The findings are characterized by tender, erythematous, subcutaneous nodules which may undergo spontaneous ulceration with discharge of brownish and viscous ... ...

Abstract	Pancreatic panniculitis is a rare disorder affecting 2-3% of patients with pancreatic disease. The findings are characterized by tender, erythematous, subcutaneous nodules which may undergo spontaneous ulceration with discharge of brownish and viscous material derived from colliquative necrosis of adipocytes. The lesions are usually localized in the lower limbs, although they may also extend to the buttocks and also involve the trunk, upper limbs and scalp. They can precede overt pancreatic disease in 40% of cases. The typical histological features observed in these lesions are characterized by necrotic adipocytes with absent nuclei (better known as 'ghost cells') in the context of a predominantly lobular panniculitis. We describe the case of a 78-year-old cirrhotic woman admitted to our department with abdominal pain affecting the upper abdomen and a 3-day fever. On physical examination, multiple tender erythematous nodules, with irregular margins, were present on the pretibial regions of both lower legs, ranging in size from 0.8 to 1.5 cm. Pancreatic amylase and lipase were elevated and abdominal computed tomography revealed acute pancreatitis with oedema, focal gland enlargement of the pancreatic tail and perivisceral inflammation. Histological examination of the lesions was consistent with a diagnosis of necrotizing granulomatous panniculitis. Learning points: Identification of the aetiological factors of tender erythematous nodules is challenging.Careful examination and history taking is essential for correct diagnosis and proper treatment.Pancreatic panniculitis should be included in the differential diagnosis as it can indicate developing acute pancreatitis.
Language	English
Publishing date	2017-04-27
Publishing country	Italy
Document type	Journal Article
ISSN	2284-2594
ISSN (online)	2284-2594
DOI	10.12890/2017_000540
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