Search results

Clinical Oncology

DECEMBER 10, 2016

[Biopharmaceuticals]

LÉVAY György

[Biopharmaceuticals represent a new class of very effective medications in the management of debilitating and often life-threatening diseases but the costs of these therapies exceed the costs of regular therapies. Biological medicinal products (i.e. smaller proteins or monoclonal antibodies) are mostly complex macromolecules, produced by microbial or mammalian cell cultures in bioreactors through application of complex process technologies. After patent expiry, the production of compounds with comparable quality features and comparable clinical safety and effi cacy profi les become available, however, the complexity of the macromolecules means they are not equivalent in the sense of small molecule generics. Biologics that are similar to a given licensed reference compound and meet regulatory requirements within this context can be termed as biosimilars. The similarity of the two products must be appropriately proven during the products’ marketing-authorisation procedure. As more and more biosimilar compounds have been approved by regulatory authorities in the EU and US it is expected that these products will bring signifi cant healthcare savings and much greater patient access to these revolutionary therapeutics.]

Lege Artis Medicinae

NOVEMBER 20, 2013

[Therapeutic strategies in rheumatoid arthritis]

VÁNCSA Andrea, SZEKANECZ Zoltán

[In this review, we follow the consecutive steps of the internationally accepted therapeutic strategy of rheumatoid arthritis (RA). We summarise in brief the current European recommendations, and provide some advice on methotrexate (MTX) therapy. The initiation, maintenance and, if needed, switch of biological therapy is also discussed. Having reached remission or low disease activity (LDA), tapering or discontinuation of biologics may be considered. Finally, we review the possibilities and the most important biomarkers of personalised treatment.]

Hypertension and nephrology

SEPTEMBER 20, 2011

[Biosimilar erythropoesis stimulating agents - from registration to clinical practice]

KISS István

[The original patent drugs appear immediately on expiry of all rights in generic and biosimilar drugs in the pharmaceutical market, favorable supply option which helps in the rational management of medicines, mainly for generic drugs cheaper to allow more patient care. Of course, this is a well-organized legal and regulatory framework, thoughtful strategy can be successful in every respect. In another non-identical molecular structure biosimilar drugs in different immunogenicity of knowledge and risk is not defined in clinical practice and therefore the risk is still underestimated and not well regulated in the world, and increasing the number reported is the antibody formation case of a biosimilar erythropioetin also. The immunogenicity of original biological and of biosimilar drugs in identifying, defining a prominent role in the post-marketing surveillance, pharmacovigilance, and the special methods of control of immunogenicity. The original and the biosimilar medicines interchangeability, marketability of the assets relating to the regulations are not uniform in Europe or the European registration scheme is an important new biosimilar medicinal products, is that the medicinal product, the documentation is not expected to be accompanied by a risk management plan, as well as action to ensure the safety (pharmacovigilance) as part of the collection and reporting of adverse reactions to the official. It is important that the professional management of renal anemia guidelines - the practice of nephrology erythropoietin therapy - clearly define the biological medicines (originator and biosimilar erythropoietin) application requirements and suggestions. Consequently, this summary wants to draw attention to the therapeutic potential of biosimilar drugs, generic drugs to distinguish between explicit and the potential risks and the need to reduce the risks of professional and health policy decisions.]

Lege Artis Medicinae

JULY 27, 2009

[Combination of leflunomide and biologic agents in the treatment of rheumatoid arthritis]

SZŰCS Gabriella

[Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease that leads to progressive joint destruction, functional disability and extra-articular complications. The initial approach to treatment of RA begins with the diagnosis, estimation of patient’s prognosis and the implementation of a therapeutic plan. Most important is early and aggressive treatment with disease-modifying antirheumatic drugs (DMARDs). Among the different protocols, combination therapies including methotrexate and/ or biologics seem to be more effective than monotherapies. Biological therapies introduced in recent years opened a new era in the treatment of RA. Randomized, controlled trials have demonstrated that the addition of methotrexate to biologic agents, such as tumor necrosis factor alpha (TNF-α) inhibitors generally increases their ability to retard structural damage, reduce disease activity and improve function. However, not all patients tolerate or respond to methotrexate. One of the most common used alternative DMARDs is leflunomide. Earlier several smaller retrospective studies, later prospective cohort studies, and finally two new populationbased longitudinal observational studies found that the above-mentioned parameters in RA patients treated with anti-TNF agents and leflunomide were similar to those receiving anti-TNF and methotrexate in combination. In addition, there were no significant differences in the frequency of adverse events between the groups. Taken together, leflunomide should be regarded as an effective and safe alternative in the treatment of rheumatoid arthritis.]