منابع مشابه
Biosimilar Oncology Drugs in Europe: Regulatory and Pharmacovigilance Considerations
The introduction in clinical practice of pharmaceutical products known as biosimilars, as part of a more complex series of progress in the field of biological drugs, represents an excellent therapeutic resource. A biosimilar drug is a biological/biotechnological drug that is highly similar to an approved reference biologic product. Given their complexity, biosimilars require attention and a con...
متن کاملPharmacology of biosimilar candidate drugs in rheumatology: a literature review.
OBJECTIVE To review current evidence concerning pharmacology of biosimilar candidates to be used in rheumatology. METHODS A PubMed search up to August 2013 was performed using relevant search terms to include all studies assessing pharmacological properties of biosimilar candidates to be used in rheumatology. Data on study characteristics, type of intervention, pharmacokinetics (PK), pharmaco...
متن کاملRegulatory and clinical considerations for biosimilar oncology drugs.
Biological oncology products are integral to cancer treatment, but their high costs pose challenges to patients, families, providers, and insurers. The introduction of biosimilar agents-molecules that are similar in structure, function, activity, immunogenicity, and safety to the original biological drugs-provide opportunities both to improve health-care access and outcomes, and to reduce costs...
متن کاملThe use of biosimilar drugs in psoriasis: a position paper.
-The development of biologic therapy has substantially improved the treatment of psoriasis and psoriatic arthritis. At the same time, the elevated cost of biologics has prompted debate on the economic sustainability of the public health system. -As patents expire for biologics, business interests and the high capacity of today’s biotechnology industry have encouraged laboratories to develop new...
متن کاملPosition paper from the Spanish Society of Rheumatology on biosimilar drugs.
A biosimilar (BS) is a biological drug that contains a version of the active substance of an already authorized original biological product. The BSs are marketed after patent period of the original drug has ended and once it has been demonstrated that the differences regarding the innovative medicine have no relevant effect on its safety or clinical efficacy. The Spanish Society of Rheumatology...
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ژورنال
عنوان ژورنال: Journal of Clinical and Analytical Medicine
سال: 2012
ISSN: 1309-0720,1309-2014
DOI: 10.4328/jcam.882