U.S. Food and Drug Administration issued the following announcement on March 19.
Fast responding to Scott Gottlieb, FDA Commissioner's statement on 7thMarch that the naming guide that requires a four letter suffix attached to the nonproprietary name of biological drugs will now only apply to biosimilars, Prof. Niazi, filed a citizen petition demanding the FDA to withdraw the guidance to prevent vested interests from misguiding prescribers and patients that biosimilars have different safety and efficacy. The FDA has accepted the petition for review and designated it as FDA 2019-P-1236.
The guidance on Nonproprietary Naming of Biological Products intended to assure traceability of biosimilar produts is redundant, according to Niazi, since the NDC number, the batch number and the expiry date, as used for all other products, are adequate for pharmacovigilence compliance. This suggestion of Niazi was adopted by Health Canada on 14 February 2019 by rejecting the use of a suffix and instead, requiring biosimilars to have a band name and a DIN. Niazi suggests that the FDA adopt a similar policy since the use of suffixes, such as in last names, is intended to establish a different identity; this mindset is widely exploited by the vested interests that the FDA considers biosimilars as dissimilarproducts, a teaching that is now easier to promote since the FDA has now removed the suffixes for the originator products.
The Citizen Petition also demands that the FDA stop labeling biosimilars as having "no clinically meaningful difference with reference product," to stop the argument that there are differences and since biosimilars are not tested in patients in all indications, the FDA cannot guarantee safety and efficacy. Niazi suggests using a statement that "biosimilars are clinically similar," to promote adoption of biosimilars.
Prof. Niazi has authored the largest number of books and papers on the subject of biosimilars. His citizen petition (FDA-2018-P-1876-001) resulted in the withdrawal of a pivotal FDA guidance on statistical testing of biosimilars. Prof. Niazi has demonstrated that biosimilars can be developed at a much lower cost and anticipates a 60-70% drop in prices, in the near future. Pharmaceutical Scientist, LLC, has been assisting companies develop and market affordable biosimilar products across globe for over 25 years and regulatory agencies on creating guidance, including the FDA.
Contact: niazi@pharmsci.com.com; +1-312-297-0000; www.niazi.com; www.pharmsci.com
Citizen Petitions: https://www.regulations.gov/document?D=FDA-2019-P-1236-0001
FDA Guidance: https://www.fda.gov/downloads/drugs/guidances/ucm459987.pdf
Original source can be found here.
