Rheumatology Drug Updates: Biosimilars Seek Regulatory Approval in the U.S., Europe; Methotrexate Underused

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

Pro Pharma Communications International. EMA recommends approval of etanercept biosimilar. GaBI Online. 2015 Nov 27.
Pro Pharma Communications International. Amgen submits biosimilar adalimumab application to FDA. GaBI Online. 2015 Nov 27.
O’Dell JR, Rohr M, Cohen SB, Thorne JC, Mikuls TR. Underuse of methotrexate (MTX) in the treatment of rheumatoid arthritis (RA) in the United States (US): Results of a comprehensive pharmaceutical claims analysis. Arthritis Rheumatol. 2015;67(suppl 10).
Strand V, Kosinski M, Graham N, et al. Impact of sarilumab on fatigue, pain, morning stiffness, productivity and health related quality of life (HRQoL) in patients with active rheumatoid arthritis who were inadequate responders or intolerant of anti-TNF-Î± therapy: Results from a phase 3 study (RCT). Arthritis Rheumatol. 2015;67(suppl 10).
Pfizer Inc. News release: Pfizer’s Lyrica fails Phase III study in post-traumatic neuropathic pain. First Word Pharma. 2015 Nov 25.
University of Warwick. News release: Researchers create world’s first ibuprofen patch—delivering pain relief directly through skin. 2015 Dec 8.

In Europe, an etanercept biosimilar is getting closer to being approved to treat RA and more, and in the U.S., an application for an adalimumab biosimilar has been submitted for FDA approval. Also, an analysis of methotrexate use in the U.S. shows that therapy may actually be underused for RA…

The availability of biosimilars for the treatment of patients with rheumatic diseases exploded in 2023. Here’s where we stand and what to expect going forward.

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…

Sarilumab is now FDA approved to treat adults with polymyalgia rheumatica who have had an inadequate response to glucocorticoids or who cannot tolerate a glucocorticoid taper. This new indication is based on results from the multicenter, phase 3 SAPHYR trial.

References

Biosimilars Seek Regulatory Approval in the U.S. & Europe; Plus MTX Underused in the U.S.

Marching to the Biosimilar Beat: Questions on Rollout Remain

Rheumatology Drugs at a Glance, Part 3: Rheumatoid Arthritis

FDA Approves Sarilumab for the Treatment of Adults with Glucocorticoid-Resistant PMR

References

Related Articles