FDA Approves Pfizer’s Biosimilar of J&J’s Remicade
The US Food and Drug Administration (FDA) has approved Pfizer’s Ixifi (infliximab-qbtx) as a biosimilar to Johnson & Johnson’s (J&J) Remicade (infliximab), an anti-inflammatory drug, for all eligible indications of the reference product. Remicade had 2016 sales of $6.97 billion.
The FDA approved Ixifi, a chimeric human-murine monoclonal antibody against tumor necrosis factor, for treating patients with rheumatoid arthritis, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
Pfizer previously received FDA approval for another Remicade biosimilar, Inflectra (infliximab) through its subsidiary, Hospira, which Pfizer acquired in September 2015 for $17 billion. In 2009, Hospira and Celltrion, an Incheon, Korea-based life-sciences company, formed a pact for developing biosimilars, including Inflectra. Pfizer holds exclusive commercialization rights to Inflectra in the US and certain other jurisdictions. The FDA approved Inflectra from Hospira and Celltrion in April 2016.
In February 2016, Sandoz, the generics arm of Novartis, acquired the rights for the development and commercialization of Ixifi in the European Economic Area, which includes the 28 member states of the European Union plus Iceland, Liechtenstein, and Norway. Sandoz acquired the rights to infliximab (i.e the active pharmaceutical ingredient in Ixifi) as part of Pfizer satisfying requirements from the European Commission to divest the product in connection with its acquisition of Hospira.
Pfizer has a portfolio of three marketed biosimilar medicines outside the US: Inflectra, Retacrit (epoetin zeta), a biosimilar to J&J’s Eprex/Erypo (epoetin alfa), and Nivestim (filgrastim), a biosimilar to Amgen’s Neupogen (filgrastim). It also has a biosimilars pipeline consisting of 13 distinct biosimilar molecules in various stages of development.
In addition to Inflectra and now Ixifi, another biosimilar to Remicade is Renflexis (infliximab-abda), which was launched in July 2017 from Merck & Co. and Samsung Bioepis, a joint venture between Samsung BioLogics, a contract biologics manufacturer, and Biogen.