RENFLEXIS from the MSD stable is the second infliximab biosimilar to be given TGA approval, and the company is planning a hospital launch of the product in 2017.
The original comparator drug is Remicade from Janssen-Cilag and is approved for autoimmune diseases including rheumatoid arthritis, psoriatic arthritis, psoriasis, Chron's Disease and ulcerative colitis as well as ankylosing spondylitis, each indication carrying their own conditions for prescription.
The first infliximab biosimilar launched in Australia was Hospira's Inflectra.
With a number of originator biologic medicines (primarily mAb therapies) set to come off patent, the government has estimated that increased use of biosimilar medicines will deliver as much as $880 million in PBS savings over the next five years.
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