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FDA withdraws draft guidance related to biosimilar development

Jul. 02, 2018 12:59 PM ETAmgen Inc. (AMGN) StockBy: Douglas W. House, SA News Editor31 Comments
  • The FDA has withdrawn its draft guidance on statistical methods to assess analytical similarity between biosimilars and reference drugs after receiving public comments and a lone citizen petition from Pharmaceutical Scientist founder Sarfaraz Niazi, an adjunct professor at the University of Illinois.
  • Mr. Niazi recommended waiving bridging studies for qualified non-U.S. comparator drugs and encouraging payors to restrict reimbursement to biosimilars for new patients. He also identified errors in the analytical similarity testing protocols and offered alternative approaches that limit the testing to non-release quality characteristics which should reduce the number of reference product batches required, a major stalling tactic used by branded drug makers who, predictably, have lacked enthusiasm selling product to potential competitors.
  • Additional suggestions from Niazi included creating a mechanism to make reference samples more freely available, allowing more ethical in vitro immunogenicity testing, where justified, minimizing non-inferiority testing in patients because of their lack of utility, allowing the use of surrogates and markers to prove clinical efficacy, changing the pharmacokinetic testing to disposition-related parameters and allowing testing in more homogenous populations.
  • In a letter to Niazi, CDER head Dr. Janet Woodcock acknowledged that the agency will take his suggestions under advisement.
  • Biosimilar-related tickers: (NASDAQ:AMGN -0.7%)(BIIB +1.1%)(PFE -0.2%)(MYL +0.7%)(PFNX +1.3%)(NVS -1.7%)(CHRS +5.5%) (OTC:BCNQY) (AGN -0.1%)(OTCPK:MKGAF)(MNTA +0.7%)
  • Other selected tickers: (XLV -0.4%)(IHE -0.7%)(XBI +0.4%)(BIB +0.1%)(PJP)(XPH -0.3%)(OTCQX:RHHBY -0.6%)(ABBV -0.3%)(AZN -1.5%)(BMY -1%)(GSK -0.8%)(JNJ -0.5%)(LLY +0.2%)(NVO +0.7%)(SHPG -1%)(TEVA +0.2%)(VRX -0.3%)

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