This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

News
21 Oct 2016

Pfizer announces US availability of biosimilar Inflectra

Inflectra will be the first biosimilar monoclonal antibody (mAb) to be available in the US.

Pfizer will begin shipment of Inflectra (infliximab-dyyb) for injection, a biosimilar of Remicade (infliximab) to wholesalers in the US in late November 2016.

Inflectra will be the first biosimilar monoclonal antibody (mAb) and only the second biosimilar to be available in the US. It is approved for the treatment of

  • Adult patients and pediatric patients (ages six years and older) with moderate to severely active Crohn’s disease who have had an inadequate response to conventional therapy
  • adult patients with moderate to severely active ulcerative colitis who have had an inadequate response to conventional therapy
  • moderate to severely active rheumatoid arthritis in combination with methotrexate; active ankylosing spondylitis; active psoriatic arthritis; and chronic severe plaque psoriasis.
  • “Biologics have revolutionized the treatment of many life-threatening and chronic diseases. By introducing Inflectra to the US marketplace, Pfizer is helping customers access an additional high quality treatment option that promises greater savings for the healthcare system,” said Diem Nguyen, regional president North America, Pfizer Essential Health Business. “We are proud of our global leadership in biosimilars, and will continue our efforts to advance a sustainable, competitive marketplace for these therapies to deliver a high quality, consistent supply of product and long-term savings and value for patients and physicians.”

    Pfizer holds exclusive commercialization rights to Celltrion’s Inflectra in the US, and has already successfully introduced Infelctra in other markets across the globe.

    Related News

    • News Federal judge blocks Colorado's unprecedented price cap on Amgen's Enbrel

      A US federal court has halted Colorado's attempt to impose a US$31,200 annual price cap on Amgen's arthritis drug Enbrel, ruling that the pharmaceutical company would likely suffer irreparable harm. The decision represents a significant blow to...
    • News Protecting life-saving therapies: CPHI Online Podcast Series

      The latest episode of the CPHI Podcast Series dives into a critical challenge facing the pharmaceutical industry: ensuring the integrity of temperature-sensitive medications and biologics through advanced predictive technology.

    • News 2026 Outsourcing Outlook Update - pharma at a crossroads

      The pharmaceutical contract development and manufacturing organisation (CDMO) sector is experiencing unprecedented transformation, driven by evolving therapeutic complexities, geopolitical tensions, and the growing demand for specialised manufacturing ...
    • News Roche maintains German investment commitment whilst rivals scale back

      Pharmaceutical giant Roche has reaffirmed its commitment to investing in Germany, standing firm even as competitors Eli Lilly and Boehringer Ingelheim dramatically reduce their planned investments in response to controversial healthcare reforms.

    • News Women in Pharma: The History of CPHI Women in Japan

      Our monthly Women in Pharma series highlights the influential lives and work of impactful women working across the pharmaceutical industry, and how the industry can work towards making the healthcare industry and workplace more equitable and inclusive.
    • News EU drafts deal to end essential medicines shortage

      European negotiators have agreed new legislation to tackle persistent shortages of essential medicines by prioritising supply security over price in public procurement and supporting domestic pharmaceutical manufacturing with strategic funding.

    • News Thermo Fisher Scientific offloads microbiology business to PE firm Astorg

      The life sciences giant is divesting its global microbiology unit, which generated $645 million in revenue last year, to the pan-European private equity firm as part of an active portfolio management strategy. The transaction is expected to close in th...
    • News The Shift: Why Sustainability is Moving to the Centre of CPHI Milan 2026

      CPHI Online contributor David Roach takes a look at how conversations around sustainability in the pharmaceutical industry can and must be transformed into actionable deliveries, and what the inaugural CPHI Sustainability Summit means for the industry.