Rheumatology

Yesterday, Eli Lilly announced that its anti–IL-17 monoclonal antibody ixekizumab (Taltz) met the primary and key secondary endpoints in the phase 3 COAST-V trial evaluating its safety and efficacy in ankylosing spondylitis.

According to Roy Fleischmann, MD, a recent American College of Rheumatology (ACR) white paper appropriately describes issues including the nomenclature of biosimilars, the biosimilar approval pathway, and differences between biosimilars for biologic drugs and generics for small-molecule drugs. However, he takes issue with ACR's stance on substitution, extrapolation, and interchangeability.

Hope Rugo, MD, director of the breast oncology clinical trials program at the University of California at San Francisco, disucusses the conversations she is having and expects to have with fellow prescribers about biosimilars in oncology.

In late 2017, a study was published in Acta Reumatologica Portuguesa evaluating the effect adalimumab (Humira), an anti–tumor necrosis factor therapy in the treatment of patients with both short- and long-term psoriatic arthritis (PsA) disease duration.

The American College of Rheumatology (ACR)'s previous position on biosimilars was one of caution during the initial development, evaluation, and approval of these drugs, but, writes the organization, “Now that biosimilars have been used successfully in Europe, with rigorously acquired data supporting their broader use, and as the [United States] is on the verge of a similar transition, the ACR is poised to reconsider its position.”

The American College of Rheumatology (ACR), which represents over 9500 rheumatologists and rheumatology health professionals, recently submitted a letter to HHS in response to the department’s request for information on Promoting Healthcare Choice and Competition Across the United States.

A recent study, set in the Netherlands, sought to assess patients’ attitudes about redistributing unused, subcutaneously administered biologic drugs, which could allow potential cost savings for the health system. However, the study unexpectedly found alarming storage inconsistencies and patient nonadherence to storage guidelines for these drugs.

At the American College of Rheumatology (ACR)'s Winter Rheumatology Symposium, held this week in Snowmass Village, Colorado, rheumatologists from across the country gathered to discuss the latest approaches to treating rheumatoid arthritis (RA).

Pfizer announced today that PF-05280586, the company’s proposed biosimilar to reference rituximab (Rituxan, MabThera), has been shown to be equivalent to the reference in overall response rate for the first-line treatment of patients with CD20-positive, low tumor burden follicular lymphoma.

An editorial, recently published in Annals of the Rheumatic Diseases, discussed the results of a study that found that an adalimumab (Humira) concentration-based tapering strategy was not inferior to the conservative strategy, conducted over 26 weeks.

Sandoz, a division of Novartis, announced today that the FDA has accepted its Biologics License Application (BLA) for a proposed adalimumab biosimilar (referencing AbbVie’s Humira).

A recent research letter, published in the British Journal of Dermatology, reports that a biosimilar of etanercept, SB4 (approved as Benepali in the European Union and Brenzys in The Republic of Korea, Canada, and Australia), is associated with fewer injection-site reactions and less immunogenicity than reference etanercept (Enbrel), while maintaining equivalent efficacy.

Patients with rheumatoid arthritis (RA) who require a change in therapy from anti–tumor necrosis factor inhibitor (anti-TNF) treatments to biologics with a different mechanism of action (MOA) had higher treatment persistence and lower healthcare costs than patients who cycled anti-TNF drugs, resulting in lower healthcare costs per persistent patient among the MOA switchers, a recent study finds.

Novartis announced today that it is initiating the SURPASS trial, a head-to-head clinical trial of secukinumab (Cosentyx) versus a proposed biosimilar adalimumab (referencing Humira and being developed by Sandoz, a Novartis division) in patients with ankylosing spondylitis.

Australian biosimilar developer NeuClone has announced that it is developing a proposed biosimilar denosumab (referenced on Amgen’s Prolia, Xgeva).

Momenta Pharmaceuticals’ M923, a proposed adalimumab (Humira) biosimilar, showed bioequivalent pharmacokinetics (PK) and similar safety and tolerability to both EU- and US-licensed Humira in healthy subjects, according to findings from a phase 1 study published today in Pharmacology Research and Perspectives.

While the European experience with biosimilars is one of significant uptake of biosimilars, individual European nations have had distinctly different levels of uptake. These differences are largely due to local variation in pricing and reimbursement, education levels, population characteristics, and stakeholder incentives.

AbbVie is increasing Humira's price by 9.7%. That price increase could add $1.2 billion to the US healthcare system’s drug costs in 2018, according to one analyst.

Today, Indian drug maker Hetero launched a biosimilar of adalimumab (referenced on Humira, made by AbbVie) to be marketed in India under the name Mabura. This is the fourth biosimilar Hetero has brought to the Indian market.

A new study used flow cytometry to compare phosphorylation levels of intracellular epitopes in peripheral blood mononuclear cells from patients with psoriasis in clinical remission who were treated with reference infliximab versus healthy controls, and further evaluated whether a switch from reference infliximab to biosimilar CT-P13 affected intracellular phosphorylation patterns.

A phase 3 trial of SB5, a proposed biosimilar to adalimumab (AbbVie’s Humira), showed that SB5 was equivalent to its reference with respect to the American College of Rheumatology's 20% improvement criteria (ACR20).

A newly published study evaluating LG Chem's proposed biosimilar etanercept in comparison with its reference (Enbrel) found that LBEC0101 had equivalent clinical efficacy and a comparable safety profile to the reference etanercept, and that the proposed biosimilar was well tolerated.

According to Marcus Snow, MD, assistant professor of internal medicine in the division of rheumatology, University of Nebraska Medical Center, some of the most critical developments in the biosimilars space during 2017 were the result of payer decisions.