ok guys i just translated this (4 hours old} Spectrum and Viropro will study the development of [biodzhenerika]
Spectrum Of pharmaceuticals and Viropro Of inc will study the development of [biodzhenerika] of the known antitumorigenic preparation Of rituximab, joint production Of roche/Genentech, reports “[KhimRar]”.
At present, Rituximab is intended for the protein CD20 and is approved as the treatment of chronic lymphocytic leukemia, [nekhodzhkinskoy] lymphoma ([NKHL]), and rheumatic arthritis. Preparation assembled 5.6 billion dollars in international sales during 2009 g. the patent protection, which covers its different use, as they expect, since October 2014. it will begin to conclude.
During the treatment [NKHL] Of rituximab is used as the first line, the second line and the supporting therapy. Preparation is sold Roche in Europe under the commercial stamp Of mabThera, and in the remaining part of the peace - as Rituxan of Biogen Of idec and Genentech, with exception of Japan, where the preparation is together sold by the companies Of chugai and Zenyaku Of kogyo.
The bill of the reform of public health, accepted in the past year by President [Barak] [Obamoy], included the legislation, which ensures the way of the approval of biosimilars. According to law about the price competition and the innovations of biological medicines (Biologics Of price Of competition and Innovation of Acts) original biological preparations and control preparations, will possess the 12-year period of [eksklyuzivnosti].
During this time, FDA will not in the state sanction biosimilars through the accelerated mechanism, by which the aspirants can pass all or specific clinical tests. However, companies, which conduct the complete set of clinical tests, can obtain approval FDA by completely legal way, it is analagous to how this occurs for the biological preparations and not to wait 12 years. Bio-like claims cannot be given to the expiration of four year old period after the approval of standard product.
As report the analysts of industry, in the world, between 2008 and 2015 yr., biologicals 59 billion of dollars confronting, they will lose patent protection. In contrast to the [nepatentovannykh] means, which, after appearing on the market, lead to the 90% price erosions of [brendovykh] preparations (after the loss by the latter of patent protection), brought out for the market for biosimilars they can cost only to 30-50% less than biologicals. It is expected that since 2012 ; the market for biosimilars will show an increase in the incomes of by approximately 10 billion dollars each year - and so it will continue, as a minimum, until 2020.
News of medicine and pharmacy from [Remedium]
The keywords: Spectrum, Viropro, development, [biodzhenerik]
Last [videonovosti]
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