The first biosimilar for infliximab has been launched in 12 new European markets, including the United Kingdom.1 Abroad, Remsima (infliximab) developed by Celltrion Inc., is indicated for the treatment of rheumatoid arthritis (RA), ankylosing spondylitis, psoriasis, psoriatic arthritis and Crohn’s disease. Remsima has shown comparability in efficacy, safety and quality to its reference product Remicade. Marketing authorization was obtained in September 2013 from the European Medicines Agency for marketing abroad.
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Explore This IssueApril 2015
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Biosimilar infliximab is currently being reviewed by the FDA. Most recently, FDA postponed a meeting of the Arthritis Advisory Committee scheduled for mid-March, which was to discuss the infliximab biosimilar CT-P13.2
Hospira has exclusive rights to market biosimilar infliximab in the U.S., if and when it garners approval.
Arhalofenate is currently in Phase 2b studies for reducing gout flares.3 Arhalofenate appears to lower serum uric acid (sUA) levels by blocking its reabsorption in the proximal tubules, inhibiting a renal uric acid transporter (URAT1), causing a uricosuric effect. It also has antiinflammatory activities. Recent study results indicate a reduction in gout flares in patients without co-administered colchicine. The 12-week, randomized, placebo- and active-controlled, double-blind, Phase 2b study treated gout patients with hyperuricemia with at least three flares in the prior year. The primary endpoint was met. There was a 46% reduction in flare rate for patients who received 800 mg daily arhalofenate compared with 300 mg allopurinol daily. A secondary analysis showed a lower flare rate of 41% compared with placebo-treated patients. Reductions in sUA were statistically significant for arhalofenate 600 mg and 800 mg, but did not lead to a statistically significant number of patients reaching the goal sUA of <6 mg/dL.
Phase 3 studies are planned for 2016 for this potential new gout therapy class, known as ULAFT (urate-lowering anti-flare therapy).
ALO-02 (oxycodone and naltrexone) extended-release capsules are an abuse-deterrent, combination formulation for managing pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.4 The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for this product, which had been designed to reduce abuse via the intranasal, intravenous and oral routes when crushed.
The formulation consists of sequestered naltrexone surrounded by extended-release oxycodone pellets. When administered as directed, patients receive oxycodone as an extended-release preparation. If pellets are crushed for abuse or misuse, naloxone is released and inhibits the oxycodone effect. ALO-02 was studied in two Phase 3 trials in patients with moderate to severe, nonmalignant pain.
Due to … serious adverse events, the manufacturer has decided not to continue developing decernotinib for RA.
Baricitinib is an oral, once-daily, selective janus kinase inhibitor (JAK) for JAK1 and JAK2. In a Phase 3 trial, it showed statistically significant improvements in patients with moderate to severe active RA compared with placebo.5 Patients in this study, known as RA-BUILD (n=684), had RA and did not tolerate or had an inadequate response to at least one nonbiologic disease-