Variability of intended copies for etanercept (Enbrel®): Data on multiple batches of seven products.

Fusion protein and monoclonal antibody-based tumor necrosis factor (TNF) inhibitors represent established treatment options for a range of inflammatory diseases. Regulatory authorities have outlined the structural characterization and clinical assessments necessary to establish biosimilarity of a new biotherapeutic product with the innovator biologic drug. Biologic products that would not meet the minimum World Health Organization's standard for evaluation of similar biotherapeutic products are available in some countries; in some cases relevant data to assess biosimilarity and appropriate regulatory approval pathways are lacking.

Analytical and Clinical Evaluation of an Immunoassay for Estimating Immunogenicity of Infliximab and Etanercept in Indian Population.

Background / Objectives: Biologic anti-TNFs in India have improved the patient management. Significant proportions of patients lose response over time or do not respond. Possible explanations are suboptimal trough anti-TNFa concentrations or antibodies to anti-TNFs.

Literature review of rheumatoid arthritis in India.

Aim: Rheumatoid arthritis (RA) can lead to severe disability. This literature review assessed the descriptive epidemiology, comorbidities and extra-articular manifestations, functioning abilities and quality of life, and treatment patterns of RA patients in India.

Method: A literature review of all observational studies published from 1985 to 2012 was conducted using MEDLINE and Embase.

Soft tissue rheumatism.

Soft tissue rheumatism includes disorders of tendons and their sheaths, ligaments, bursae, joint capsules, muscles, fasciae and others. Inflammatory signs or systemic manifestations may be lacking in these disorders. Fibrositis, bursitis, tenosynovitis, myositis are some of the common types of soft tissue rheumatism.