Us generic industry puts pressure on FDA on the naming standard of bio generic drugs

Source: Ding Xiangyuan September 23, 2013 according to the U.S generic industry, all bio generic products listed in the U.S should have the same non exclusive name as the brand bio medicine they copied Gpha, the trade body, has filed a citizen petition with the US Food and Drug Administration (FDA) saying there is no clinical difference between branded biopharmaceuticals and biopharmaceuticals that require unique names "It's very simple, because there is no clinically significant difference between biosimilars and their reference products, they should have the same name," said Ralph NEAs, President and CEO of gpha The U.S regulatory approach to biosimilars, which are derived from living cell drugs, is still in its infancy, and only released its first guidelines last year to help the biopharmaceutical industry develop such products and put them on the market However, there are still many problems to be solved, including what standards these products should follow to be named For standard generic drugs (generic drugs of brand drugs manufactured through chemical processes), non proprietary names or API names are required for product sales However, some groups, such as the Alliance for the safety of biological drugs (ASBM), argue that biosimilars should have their own scientific names different from brand drugs to avoid possible safety problems ASBM members include Amgen, Genentech and many patient and medical professional groups ASBM expressed concerns to FDA in September last year, citing a survey that confirmed that 64% of doctors would think that if the product had the same scientific name, the patient could be safely transferred from using one drug to using another during the treatment period At that time, Dr Richard dolinar, President of ASBM, said that there was a problem because "biopharmaceuticals are produced by living cells, and biopharmaceuticals will only be similar, rather than equivalent to the original drugs" This view was refuted by gpha, which said that the United States should follow the example of Europe, where bio generic drugs have the same scientific name as brand bio drugs, and there has been no problem in traceability or pharmacovigilance "Disrupting the naming system can cause confusion and have a negative impact on the global drug supply chain, potentially endangering the use of drugs by patients around the world," said NEAs, President of gpha Gpha said it would continue to encourage dialogue between FDA and other stakeholders to explore the best way to support the existing pharmacovigilance system and optimize data collection to ensure patient safety.