U.S. Senator wants FDA to disclose biosimilar naming policy

Source: China Council for the promotion of drugs 2014-08-07 a week after the US Food and Drug Administration (FDA) received the first application for approval of bio generic drugs, several US senators have asked when the US Department of health and human services (HHS) will adopt the formal policy of naming these drugs Their letters, like the new who proposal to name biosimilars, are aimed at promoting the replication of branded biosimilars and are expected to save billions of dollars in medical costs The question now is whether biosimilars should be given the same international proprietary name or international non proprietary name (inn) as brand biosimilars The World Health Organization oversees the global Inn system, but regulators in each country are exempt from the latest who proposals As we mentioned earlier, the naming debate is particularly contentious and polarizes the pharmaceutical industry, with both sides lobbying the FDA to set the course of action At the heart of the debate was whether different international non proprietary names would impede the use of alternatives needed to reduce medical costs Brand pharmaceutical companies and biotech companies want biosimilars to have a unique or generic name that distinguishes them from original biopharmaceutical drugs They think different names are easy to track adverse events Generic manufacturers argue that the new naming standard could confuse health care providers in determining whether drugs are really the same and in trying to verify the dosage They insist that side effects can be traced through national drug codes and batch numbers Generic manufacturers also point out that branded pharmaceutical companies and biotech companies are trying to reduce the competitiveness of biosimilars before they are widely used in the United States Pharmaceutical companies on both sides of the dispute have asked the FDA to adopt their views Although five Republican members of the Senate health, education, labor and Pensions Committee mentioned in their letter that they believed the FDA had submitted the naming guidelines to HHS for review, the FDA remained silent about its plan The FDA spokeswoman only said the agency "is currently considering appropriate international naming rules." We will take into account all the comments we have received in advancing future policy development, including naming " We are looking for HHS's opinion and will let you know if you have any reply Senators are concerned that the FDA has begun reviewing applications for biosimilars and will meet with pharmaceutical companies before its program guidelines become public Generally, the draft FDA guidelines will be made public and any comments can be made before finalization Two weeks ago, Novartis sold Sandoz, a generics subsidiary, seeking FDA approval to sell a biosimilar drug that mimics neupogen, the company's biologics used to reduce the risk of chemotherapy infection in cancer patients This is considered to be the first bio generic application submitted to FDA This is not the first time that the FDA's biosimilars naming policy has attracted the attention of Senate members Last fall, the FDA canceled discussions on its website about the naming policy for biosimilars, which senators believe marks a shift for U.S FDA officials to be private At that time, six U.S senators - including five Democrats and one Republican - opposed any request for an inn that would require a biosimilar drug to have a unique identity different from a brand of biological agent There is no clear position in this letter Original link: http://blogs.wsj.com/pharmolot/2014/08/05/senators-want-fda-to-disclose-policy-for-naming-biosimilars/