Pfizer has accused J&J of restricting biosimilar uptake through uncompetitive practises in its efforts to maintain a monopoly for its bestselling mAb Remicade (infliximab).
Bestselling biologic Remicade (infliximab) will remain a multi-billion dollar product for J&J for at least the next five years, even with biosimilar competition the firm says.
A two year-long Phase IV study has shown Celltrion’s infliximab biosimilar is not inferior to its originator Remicade, but a physician group still urges caution when switching.
Celltrion’s CT-P13 has been declared “highly similar” in safety and efficacy to J&J’s Remicade, and could be recommended for approval by a US FDA committee today.
Approving a biosimilar for the same diseases as the originator drug based on extrapolated data rather than study results should remain a cornerstone of the review process say regulators and developers.
As competition begins to erode worldwide sales and litigation challenges Humira’s dominance, AbbVie says it will “prevail” with its new biosimilar strategy.
Hospira, recently acquired by Pfizer, announced Monday the launch of the first biosimilar monoclonal antibody (mAb), Inflectra (infliximab), in major European markets, following the patent expiry of J&J’s Remicade.
Ranbaxy Laboratories has launched the monoclonal antibody Infimab, the first Remicade (Infliximab) biosimilar, in India -- which is the first what could be a few home-grown biosimilar launches.
