Recently, the US Food and Drug Administration (FDA) released its long-awaited draft guidance describing naming convention for biologicals, which include related and biosimilar products. The new naming convention holds substance for new as well as previously-licensed products under the Public Health Service Act. This naming convention holds great importance in the background development of the passage of the Affordable Care Act in the year 2010, in which the US created a new pathway for biosimilar products to be launched in the market. The above pathway enables companies to launch biosimilars to market quickly and in a cost-effective way backed by clinical evidence put up by the original manufacturer. Since biosimilar products do not have same chemical formula as the original product, regulators across the globe are finding it increasingly difficult to determine how these products ought to be named in the absence of any standard code, the accepted trend among regulators till recently was to find some universal method of distinguishing biological products from their biosimilars using a "biological qualifier".
FDA has finally released a draft guidance according to which biologics and their related biosimilars will have the same nonproprietary name. This name is mentioned as "proper name" in the guidance, and will have a four lowercase letter suffix in order to distinguish various other similar products. According to FDA's official blog ‘FDA Voice, the proposed naming convention will: "help prevent inadvertent substitution (which could lead to medication errors) of biological products that are not determined to be interchangeable by the FDA." There are many reports in the market which tracks the recent market trends and future growth prospects along with offering profile of key market players. Recently, Big Market Research has added a report titled “
World Biosimilars/Follow-on-Biologics - Market Opportunities and Forecast, 2014 - 2020)”, which offers an in-depth insight into the key drivers and restraints, current and future market trends along with winning strategies adopted by key market players to consolidate their market presence. The report also highlights the technological innovations brought about by prominent players along with detailed segmentation and forecast.
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https://www.bigmarketresearch.com/global-biosimilars-market