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  • Regulatory NewsRegulatory News

    Updated: FDA Form 483 for Celltrion Site Manufacturing Remicade Biosimilar

    The US Food and Drug Administration (FDA) on Wednesday released a Form 483 sent to Korea’s Celltrion with 12 observations, which an industry analyst believes could be the reason why the commercialization of Celltrion and Pfizer’s Inflectra (infliximab-dyyb), a biosimilar to Remicade, has not gone as well as planned in the US, though Pfizer says the limited uptake has more to do with Johnson and Johnson's exclusionary contracts. The Form 483 for the Incheon, Korea-base...
  • Regulatory NewsRegulatory News

    EMA’s CHMP Recommends Approval for Five New Medicines, Four New Biosimilars

    The European Medicines Agency (EMA) met earlier this week and signed off on five new medicines, including one new advanced therapy, as well as four biosimilars and one generic drug. The advanced therapy CHMP recommended is Germany-based Co Don Ag’s Spherox (spheroids of human autologous matrix-associated chondrocytes), which is intended to treat adults who have a type of symptomatic articular cartilage defects in the knee. The four other new medicines were: Dom...
  • European Regulatory Roundup: Italy Fines Aspen $5.7M for Increasing Cancer Drug Prices by 1,500% (20 October 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Norwegian Government-Funded Study Supports Switching Patients to Remicade Biosimilar A trial funded by the Norwegian government has generated data to support switching from Johnson & Johnson’s Remicade to a biosimilar. Overall, participants with rheumatoid arthritis, Crohn’s disease and other conditions who switched to the biosimilar had comparable outcomes to patients ...
  • Regulatory NewsRegulatory News

    Woodcock: FDA Needs More Funds for Biosimilar Review Program

    Shuttling back and forth between two different House committee hearings on Thursday, US Food and Drug Administration’s (FDA) CDER Director Janet Woodcock made clear in a later hearing on biosimilars that the agency needs Congressional appropriations to properly run its biosimilar review program. When the Biologics Price Competition and Innovation Act (BPCIA) was enacted in 2010, FDA received no additional congressional appropriations to run the program, Woodcock said, fo...
  • Regulatory NewsRegulatory News

    FDA Receives First-Ever Biosimilar Application for Monoclonal Antibody

    South Korean biopharmaceutical manufacturer Celltrion has announced that it has filed an application for approval with the US Food and Drug Administration (FDA) for Remsima, its biosimilar version of Jannsen's Remicade (infliximab). The company's biosimilar filing is the second-ever filing of a drug through FDA's new 351(k) biosimilar pathway, and reportedly the first-ever monoclonal antibody (mAb) to seek approval through the pathway. The first biosimilar filing for ...