Abstract:
OBJECTIVE:To provide an overview of the underlying scientific principles and standards for developing a biosimilar product. METHODS:An Internet-based literature search through June 2015 was performed for information related to biosimilar manufacturing and development, including a review of regulatory guidelines and requirements. RESULTS:Biologics, both biosimilars and their corresponding reference products, are complex molecules produced by biotechnology in living systems. The development of biologics involves multiple levels of intricate, highly controlled manufacturing processes, combined with pre-clinical structural, functional, and biological assessments, as well as clinical efficacy and safety, including immunogenicity, analyses. In addition, to ensure a high degree of similarity, a biosimilar must undergo a comparability exercise at every step of its development, as outlined by regulatory agencies, to demonstrate that potential differences from the reference product are not clinically meaningful with regard to quality, safety, and efficacy [European Medicines Agency (EMA)] or safety, purity, and potency [US Food and Drug Administration (FDA)]. At the foundation of the biosimilar development process lays the establishment of a high degree of structural similarity with its reference product. State-of-the-art technologies must be employed to demonstrate a high degree of structural and functional similarity. Finally, clinical pharmacokinetic and pharmacodynamic as well as clinical efficacy and safety similarity must be confirmed between biosimilar and originator. Regulators, including the FDA and the EMA consider the totality of the evidence from this comprehensive step-wise comparative similarity exercise in its determination of biosimilarity for licensing. CONCLUSIONS:The rigorous and highly regulated processes required to develop a biosimilar have been designed as such to establish a high degree of biosimilarity with a reference product in terms of the structural, functional, biological, and clinical attributes.
journal_name
Semin Arthritis Rheumjournal_title
Seminars in arthritis and rheumatismauthors
Al-Sabbagh A,Olech E,McClellan JE,Kirchhoff CFdoi
10.1016/j.semarthrit.2016.01.002subject
Has Abstractpub_date
2016-04-01 00:00:00pages
S11-8issue
5 Suppleissn
0049-0172issn
1532-866Xpii
S0049-0172(16)00028-7journal_volume
45pub_type
杂志文章,评审abstract::Of 500 patients with systemic lupus erythematosus observed at our center, 150 fulfilled criteria for lupus nephritis. Of these 150 patients, 91% were female, and 67% were white. The mean age of onset was 26.2 years, and the mean follow-up duration was 11.7 years. Biopsies (n = 142) performed on 107 patients showed the...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章
doi:10.1016/s0049-0172(95)80017-4
更新日期:1995-08-01 00:00:00
abstract:OBJECTIVE:The aims of this study are (1) to report 33 patients with Behçet's disease (BD) having various renal manifestations, and (2) to update current data using our patients and published papers about BD and renal manifestations. METHODS:The PubMed database was searched using the terms BD or Behçet's syndrome. We f...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/j.semarthrit.2007.11.001
更新日期:2008-12-01 00:00:00
abstract:BACKGROUND:Autoimmune inner ear disease (AIED) was first described in 1979 and the disease has become more widely recognized over the last decade. Limited information is available regarding clinical features of the disease, disease course, and response to treatment. OBJECTIVE:To analyze data from 42 patients with docu...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章
doi:10.1016/j.semarthrit.2004.07.001
更新日期:2004-10-01 00:00:00
abstract:BACKGROUND:Progressive-psuedorheumatoid-arthropathy of childhood (PPAC) is an autosomal recessive single gene skeletal dysplasia involving joints. The gene attributed to its cause is WNT1-inducible-signaling pathway protein3 (WISP3). OBJECTIVE:To study the clinical and radiographic presentation of PPAC in Indian patie...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/j.semarthrit.2012.09.001
更新日期:2013-06-01 00:00:00
abstract:INTRODUCTION:Systemic sclerosis (SSc) is an autoimmune disease characterized by vasculopathy, autoimmunity, and widespread dermal and visceral fibrosis. This article summarizes the current knowledge about the potential contribution of platelets in the disease process and the rationale of targeting platelets as an adjun...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/j.semarthrit.2017.05.004
更新日期:2017-12-01 00:00:00
abstract::In the middle of the 20th century, biologists focused on investigating the mechanism of gene regulation and signal transduction in cells, which led to the concept that metabolites were products of gene expression and signal transduction pathways. In the 1920s, the importance of cellular metabolism was shown in the War...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/j.semarthrit.2019.04.006
更新日期:2019-06-01 00:00:00
abstract:OBJECTIVES:To estimate the prevalence, incidence, mortality, and predictors of cancer in patients with rheumatoid arthritis (RA). METHODS:We compared the incidence of cancer and the mortality by cancer in a cohort of 789 randomly selected RA patients (1999-2005) with the expected ones in the general population. We est...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,多中心研究
doi:10.1016/j.semarthrit.2007.08.006
更新日期:2008-06-01 00:00:00
abstract:BACKGROUND:Ankylosing spondylitis (AS) is a chronic inflammatory disorder that affects approximately 350,000 patients in the United States. Over time, the spinal and peripheral joint involvement of AS may cause severe disability and functional limitations. Research in the molecular and cellular events of AS has uncover...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/j.semarthrit.2004.08.005
更新日期:2005-02-01 00:00:00
abstract::It is not widely appreciated that endocrine disease may present primarily as rheumatic syndromes, sometimes spectacular in onset, more commonly insidious and subtle, making their true recognition difficult. The underlying hormonal, biochemical, and metabolic events have understandable reflection in the structure and f...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/0049-0172(79)90002-7
更新日期:1979-08-01 00:00:00
abstract:OBJECTIVES:To contrast and compare the spectrum of remitting seronegative symmetrical synovitis with pitting edema (RS3PE) with rheumatoid arthritis (RA) using an illustrative case. METHODS:The relevant English literature of RS3PE was searched using the keywords "RS3PE" alone and in combination with terms such as neop...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/j.semarthrit.2008.11.006
更新日期:2010-08-01 00:00:00
abstract:BACKGROUND/PURPOSE:Treat-to-target (TTT) is a recommended strategy in the management of rheumatoid arthritis (RA), but various data sources suggest that its uptake in routine care in the US is suboptimal. Herein, we describe the design of a randomized controlled trial of a Learning Collaborative to facilitate implement...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.semarthrit.2016.02.009
更新日期:2016-08-01 00:00:00
abstract:OBJECTIVES:To evaluate the capacity of B-Mode ultrasonography (B-Mode US) and electron-beam computed tomography (EBCT) to detect arterial changes in Takayasu's arteritis. METHODS:EBCT angiography of the thoracoabdominal aorta and pulmonary artery, and B-mode US of large superficial arteries (common carotid, subclavian...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章
doi:10.1053/sarh.2000.8375
更新日期:2000-08-01 00:00:00
abstract:OBJECTIVE:To assess the association of clinical and/or serological parameters with ultrasound-defined disease activity in rheumatoid arthritis (RA). METHODS:Retrospective analysis of 149 consecutive RA patients routinely assessed by sonography of the wrists, metacarpo-phalangeal, and proximal interphalangeal joints. S...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章
doi:10.1016/j.semarthrit.2011.09.005
更新日期:2012-06-01 00:00:00
abstract:OBJECTIVES:To conduct a systematic review of incidence and prevalence studies of rheumatoid arthritis (RA), based on the 1987 revised American College of Rheumatology (ACR) criteria, to compare their methodologies and summarize their results, and to investigate the possible geographic variations and changes over time i...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/j.semarthrit.2006.08.006
更新日期:2006-12-01 00:00:00
abstract:OBJECTIVES:Posterior interosseous nerve (PIN) palsy is a very rare complication of rheumatoid arthritis affecting the elbow joint. It results in weakness of extension of the fingers and may be confused with extensor tendon rupture and wrist drop due to radial nerve damage. METHODS:We present a case of PIN palsy second...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/j.semarthrit.2010.07.011
更新日期:2011-06-01 00:00:00
abstract:OBJECTIVES:To report 2 patients with systemic lupus erythematosus and typical shrinking lung syndrome (SLS) in which pleuritic chest pain was the predominant symptom. In addition, to record the prevalence of pleuritic chest pain in all reported cases of patients with SLS and diaphragmatic dysfunction. METHODS:We condu...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/j.semarthrit.2008.04.003
更新日期:2009-08-01 00:00:00
abstract:OBJECTIVE:Neuropathic pain (NP) mechanisms contribute to the pain experience in osteoarthritis (OA). We aimed to characterise the factors that contribute to NP-like symptoms in knee OA patients. PATIENTS AND METHODS:A total of 139 patients with knee OA were recruited from secondary care, and completed a nurse- adminis...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章
doi:10.1016/j.semarthrit.2013.10.001
更新日期:2014-04-01 00:00:00
abstract:BACKGROUND:Glucocorticoids (GC) are the mainstay of treatment of polymyalgia rheumatica (PMR). However GC-related adverse events occur frequently, particularly in patients with relapsing disease. Several studies have demonstrated that IL-6 is a key player in the pathogenesis of PMR. OBJECTIVES:To report 2 patients wit...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/j.semarthrit.2013.01.003
更新日期:2013-08-01 00:00:00
abstract::Mechanical injury is the most important risk factor in osteoarthritis (OA) development. Although once considered a passive disease of mechanical attrition, injury drives active mechanosensitive intracellular signalling which affects the structural and symptomatic course of disease. Mechanosensitive signalling in carti...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/j.semarthrit.2019.09.018
更新日期:2019-12-01 00:00:00
abstract::A number of studies show the efficacy of methotrexate (MTX) for rheumatoid arthritis (RA) in general. However, is there any reason to single this drug out for early RA? Mechanistically, it probably works differently in RA than in cancer, at least in part. Thus, in addition to dihydrofolate reductase-related effects, M...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/0049-0172(94)90083-3
更新日期:1994-06-01 00:00:00
abstract:OBJECTIVE:To assess the impact of switching tumor necrosis factor (TNF)-alpha inhibitors on patients with axial spondyloarthritis (axSpA). METHODS:PubMed literature searches were conducted using combinations of search terms including ankylosing spondylitis, spondyloarthropathy, spondyloarthritis, switch/switching, dru...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/j.semarthrit.2017.04.005
更新日期:2017-12-01 00:00:00
abstract:OBJECTIVES:To report 3 cases ANCA-associated vasculitis (AAV) that developed in patients suffering from systemic sclerosis (SSc) and to review previously reported cases. METHODS:We describe 3 patients diagnosed with SSc who developed severe AAV that presented as crescentic glomerulonephritis (GN) and/or alveolar hemor...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/j.semarthrit.2010.11.001
更新日期:2011-10-01 00:00:00
abstract:OBJECTIVES:Air pollution ranks high among risk factors for the global burden of disease. The associations of air pollution and rheumatoid arthritis (RA) are controversial. This systematic review and meta-analyses has analyzed the association between outdoor air pollution and the development of RA. METHODS:PubMed, Emba...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/j.semarthrit.2019.10.005
更新日期:2020-04-01 00:00:00
abstract::The efficacy and toxicity of cyclosporine in the treatment of patients with rheumatoid arthritis (RA) are reviewed. Most of the early trials were restricted to patients with intractable RA. The initial daily dose of cyclosporine was 5 to 10 mg/kg, which is now considered high. Of 283 cyclosporine-treated patients in n...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/0049-0172(92)90046-g
更新日期:1992-08-01 00:00:00
abstract::Methotrexate therapy has been effective in the treatment of RA with short term experience suggesting little serious adverse reactions. Our review of 168 patients receiving methotrexate has identified nine patients with probable or possible methotrexate-induced pulmonary toxicity, giving a prevalence of 5% and an incid...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章
doi:10.1016/0049-0172(87)90021-7
更新日期:1987-02-01 00:00:00
abstract:OBJECTIVES:HLA-B*5801 allele carriage (a strong determinant of allopurinol hypersensitivity syndrome) varies substantially among races, which may lead to racial disparities in the risk of Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) in the context of urate-lowering drug adverse events (ULDAEs). W...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章
doi:10.1016/j.semarthrit.2016.03.014
更新日期:2016-10-01 00:00:00
abstract:OBJECTIVES:Acute gout is a common arthritis that may eventually develop into chronic tophaceous gout (CTG). CTG usually is manifested by recurrent gout attacks. The diagnosis and treatment of CTG is challenging. Although the emergence of CTG without previous gout attacks is uncommon, it is important to recognize this u...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/j.semarthrit.2017.11.006
更新日期:2018-06-01 00:00:00
abstract:OBJECTIVES:To provide an update of the current knowledge of the mechanism of action of low-dose methotrexate (MTX) in the treatment of patients with rheumatoid arthritis (RA), with an emphasis on the mechanisms involved in toxicity. We also considered strategies currently used to prevent or decrease toxicity of MTX. M...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/s0049-0172(98)80049-8
更新日期:1998-04-01 00:00:00
abstract::The shoulder, a very common site of pain syndromes in medical practice, lends itself well to precise clinical analysis and identification of the pain-sensitive structure or structures. Once identified, rational and effective management can be applied, associated with predictably good prognosis. Early identification o...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/s0049-0172(77)80003-6
更新日期:1977-08-01 00:00:00
abstract:OBJECTIVES:To study the prevalence and characteristics of retinal vascular disease in patients with systemic lupus erythematosus (SLE) and to analyze their relationship with antiphospholipid antibodies (aPL) and other serological markers. PATIENTS AND METHODS:Eighty-two consecutive patients (77 women and 5 men; mean a...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章
doi:10.1016/s0049-0172(99)80017-1
更新日期:1999-04-01 00:00:00