Experts Cite Payer Practices, Litigation Backlogs As 2018 Biosimilar Hurdles

Despite the approval of multiple biosimilars, industry wins in payment policy and release of highly anticipated FDA guidance, some experts are skeptical that 2018 will be a tipping point for the nascent biosimilar industry, citing issues with payers, lack of final FDA guidance on key issues and litigation backlogs created by late-stage patents. In 2017 FDA approved five biosimilars: Samsung Bioepsis and Merck's Renflexis (infliximab); Boehringer Ingelheim's Cyltezo (adalimumab); Amgen's Mvasi (bevacizumab); Mylan's Ogivri (trastuzumab); and Pfizer's Ixifi (infliximab). The...