Rheumatology

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EMA recommends approval of Humira biosimilar Imraldi

EMA recommends approval of Humira biosimilar Imraldi
June 23, 2017

The European Medicines Agency has recommended the approval of the Imraldi, making it the third anti-TNF biosimilar candidate to receive a positive opinion from the Committee for Medicinal Products for Human Use, the manufacturer announced.

Imraldi (SB5, Samsung Bioepis) is a biosimilar candidate referencing Humira (adalimumab, AbbVie), indicated for rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hydradentis suppurativa, Crohn’s disease in adults and children, ulcerative colitis and uveitis.

Meeting News

'Minimal' placental transfer of certolizumab pegol found for pregnant women with rheumatic diseases

June 14, 2017
MADRID — Zero to minimal placental transfer of certolizumab pegol was discovered for a cohort of pregnant women with rheumatic diseases, according to findings…
In the Journals

Screening guidelines for pediatric psoriasis comorbidities recommended

June 1, 2017
An expert panel recommended guidelines for patients with pediatric psoriasis, including routine screening and identification of certain risk factors for associated…
In the Journals

Biologic therapy not cost-effective for RA after methotrexate fails

May 29, 2017
Initiating biologic therapy in patients with rheumatoid arthritis when methotrexate monotherapy fails increases costs substantially and provides minimal incremental…

EMA recommends approval of Humira biosimilar Imraldi

June 23, 2017
The European Medicines Agency has recommended the approval of the Imraldi, making it the third anti-TNF biosimilar candidate to receive a positive…

Meeting News

'Minimal' placental transfer of certolizumab pegol found for pregnant women with rheumatic diseases

June 14, 2017
MADRID — Zero to minimal placental transfer of certolizumab pegol was discovered for a cohort of pregnant women with rheumatic diseases…

In the Journals

Screening guidelines for pediatric psoriasis comorbidities recommended

June 1, 2017
An expert panel recommended guidelines for patients with pediatric psoriasis, including routine screening and identification of certain risk factors…

In the Journals

Biologic therapy not cost-effective for RA after methotrexate fails

May 29, 2017
Initiating biologic therapy in patients with rheumatoid arthritis when methotrexate monotherapy fails increases costs substantially and provides…

Phase 3 data for Romosozumab were favorable for postmenopausal women with osteoporosis

May 26, 2017
Romosozumab met both primary endpoints in the ARCH phase 3 study of postmenopausal women with osteoporosis, according to a company release…

In the Journals

Otezla demonstrates safety up to 3 years in patients with psoriasis

May 26, 2017
Otezla demonstrated an acceptable safety profile through at least 3 years of treatment among patients with psoriasis, according to recently published…

In the Journals

Factors of methotrexate-induced epidermal necrosis identified

May 23, 2017
Researchers identified early signs and risk factors of methotrexate-induced epidermal necrosis, and physicians should use caution when deciding when…

ACR issues statement after FDA releases guidance on biosimilar interchangeability

May 23, 2017
The American College of Rheumatology has issued a statement about the FDA’s draft guidance for biosimilar interchangeability. “The…

FDA News

FDA approves Kevzara for rheumatoid arthritis

May 23, 2017
After a resubmission by Sanofi and Regeneron Pharmaceuticals Inc., the FDA has approved Kevzara for the treatment of patients with rheumatoid…

FDA NewsPerspective

FDA approves Actemra for giant cell arteritis

May 22, 2017
The FDA has approved Actemra for the treatment of adults with giant cell arteritis. “Rheumatologists will finally have available an option for…

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