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This presentation discusses the competition law issues raised by biosimilars. While many of the issues are similar to those raised by generics, the fact that, unlike generics, biosimilars are not exact copies of the original product means that the competition issues are slightly different as well. In essence, there seems to be more room for originators to pursue strategies designed to slow the entry of biosimilars into the market. ; Peer reviewed

This report discusses FDA Regulation of Biologics, Biosimilars and Regulatory Exclusivities, Patent Dispute Resolution and Current Issues.

Tadeusz Robak Department of Hematology, Medical University of Lodz and Copernicus Memorial Hospital, Lodz, PolandSafety of Biologics Therapy: Monoclonal Antibodies, Cytokines, Fusion Proteins, Hormones, Enzymes, Coagulation Proteins, Vaccines, Botulinum Toxins (Cham, Switzerland: Springer International Publishing; 2016) by Brian A Baldo from the Molecular Immunology Unit, Kolling Institute of Medical Research, Royal North Shore Hospital of Sydney, and the Department of Medicine, University of Sydney, Australia, is a book that belongs on the shelf of everyone in the field of biologic therapies research and clinical practice. In writing this book, the author's intention was to produce an up-to-date text book on approved biologic therapies, as far as that is possible in this time of rapidly evolving developments in biotherapeutic research and the introduction of new and novel agents for clinical use.The monograph comprises 610 pages in 13 chapters, each including a summary and further reading suggestions. All chapters include a discussion of basic and clinical material. Well-designed, comprehensive tables and color figures are present throughout the book. The book itself examines the biologic products that have regulatory approval in the USA and/or European Union and that show every indication of remaining important therapies. It covers in great detail all the latest work on peptide hormones and enzymes, monoclonal antibodies, fusion proteins, and cytokine therapies. Beyond that, it also presents the latest information on blood coagulation proteins, vaccines, botulinum neurotoxins, and biosimilars.

1. Introduction to biosimilar and interchangeable products -- 2. Intellectual property issues -- 3. European regulatory guidance -- 4. EMA-approved biosimilars -- 5. The FDA regulatory guidance -- 6. The ROW regulatory guidance -- 7. U.S. commercialization -- 8. Global commercialization -- 9. Quality and lifecycle management.

Biologics, which are sometimes termed biopharmaceuticals or biotechnology drugs, have begun to play an increasingly important role in U.S. health care. Not only are sales of biologics growing rapidly, some experts estimate that in coming years half of all newly approved drugs will result from biotechnology. This report contains information on marketing approval issues, intellectual property issues, and innovation issues as related to biologics.

Biologics, which are sometimes termed biopharmaceuticals or biotechnology drugs, have begun to play an increasingly important role in U.S. health care. Not only are sales of biologics growing rapidly, some experts estimate that in coming years half of all newly approved drugs will result from biotechnology. This report contains information on marketing approval issues, intellectual property issues, and innovation issues as related to biologics.

Biologics, which are sometimes termed biopharmaceuticals or biotechnology drugs, have begun to play an increasingly important role in U.S. health care. Not only are sales of biologics growing rapidly, some experts estimate that in coming years half of all newly approved drugs will result from biotechnology. This report contains information on marketing approval issues, intellectual property issues, and innovation issues as related to biologics.

Psoriasis is a chronic, immune-mediated inflammatory disease that significantly affects a patient's quality of life. Several systemic complications can influence disease progression and response to treatment. Biological therapy is considered the most effective therapeutic option in treating moderate to severe forms of psoriasis. The success of therapy may depend on its persistence, also known as drug survival. The dermatologist needs to be aware of comorbidities and factors that influence the persistence or discontinuation of biological treatment to make appropriate treatment decisions. We have identified several studies on the persistence of biologic therapy or drug survival in patients with psoriasis and summarized some of the most important issues known to date. In several recently published studies, the survival of ustekinumab is better than TNF‐α inhibitors but lower than ixekizumab. Notably, the studies were performed on a limited number of patients and follow-up time. Moreover, secukinumab appears to have a shorter drug survival than other biological agents, especially in patients with biological experience. A real indicator of therapeutic success could be a high quality of life. Female gender and obesity have been consistently highlighted among the predictors of treatment discontinuation, while psoriatic arthritis could be a predictor of persistence and maintenance of biological therapy. We are currently aiming to improve the therapy for patients treated with biological agents to reduce the pressure on the national public health system.