Rheumatology Drug Updates: Infliximab Biosimilar Gets FDA Approval & More

Michele B. Kaufman, PharmD, CGP, RPh, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

U.S. Food and Drug Administration. News release: FDA approves Inflectra, a biosimilar to Remicade. 2016 Apr 5.
U.S. Food and Drug Administration. Purple book: Lists of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations. 2016.
American College of Rheumatology. Press release: Rheumatology community responds to FDA approval of Inflectra (infliximab-dyyb), a biosimilar to Remicade. 2016 Apr 6.
Flexion Therapeutics Inc. News release: Flexion Therapeutics reports primary endpoint met in pivotal phase 3 trial of Zilretta in knee osteoarthritis. 2016 Feb 16.
Kavanaugh A, van der Heijde D, Beutler A, et al. Radiographic progression of patients with psoriatic arthritis who achieve minimal disease activity in response to golimumab therapy: Results through five years of a randomized, placebo-controlled study. Arthritis Care Res (Hoboken). 2016 Feb;68(2):267–274. doi: 10.1002/acr.22576.

In recent Phase 3 clinical trials, Zirletta proved effective in managing pain for patients with knee osteoarthritis, and subcutaneous golimumab helped patients with psoriatic arthritis achieve long-term functional improvement…

The use of biosimilars for rheumatology in the U.S. became a reality when the U.S. Food and Drug Administration (FDA) approved Inflectra (infliximab-dyyb), a biosimilar to Remicade (infliximab), in April. What this may mean is increased competition among drug companies with regard to pricing and, therefore, potentially lower costs for U.S. patients, according to Seoyoung…

The makers of FX006, a steroid injection for treating pain in patients with knee osteoarthritis, have submitted a new drug application to the FDA…

Over the past few years, biosimilars and other new drugs have been introduced to treat rheumatic illnesses. Some of the conditions we treat have numerous drug options, others have few or only off-label options. This series, “Rheumatology Drugs at a Glance,” provides streamlined information on the administration of biologic, biosimilar and small molecule inhibitor drugs…

References

Clinical Trials: Zilretta Promising for Knee OA Pain & Golimumab Completes Phase 3 Trial

Possible Impact of Biosimilar Infliximab on U.S. Market in Prescriptions, Pricing

FDA Update: FX006 Promising for Knee OA; Pioglitazone Linked to Bladder Cancer Risk; & HIV Drug Gets New Labeling

Rheumatology Drugs at a Glance, Part 3: Rheumatoid Arthritis

References

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