Biosimilars

As previous studies have shown slow uptake of biosimilars, Ross Maltz, MD, and his team wanted to get a better understanding of this issue using a survey focused on pediatric gastroenterologists.

Patients receiving tocilizumab and LZM008 showed comparable pharmacokinetic properties after a single intravenous dose.

At week 54, there were no significant differences in patients achieving the target exposure (5 µg/mL) between those in the monotherapy cohort and those in the combination therapy cohort.

Among pediatric gastroenterologists surveyed, most were comfortable prescribing an infliximab biosimilar to patients who were tumor necrosis factor (TNF)-naïve and switching to a biosimilar for those in clinical remission.

Phase 3 results presented at ARVO 2023 suggest a switch from aflibercept to SB15 led to no treatment-emergent issues such as loss of efficacy, increased adverse events, or increased immunogenicity.

An analysis of real-world data suggests intravitreal injection of biosimilar ranibizumab in a loading dose followed by a PRN protocol is a viable strategy for treating patients with nAMD.

There are many reasons why biosimilars are not utilized in gastroenterology, mainly patients present younger and treatments can lose efficacy over time.

A single-center study from India sheds light on the safety and efficacy of biosimilar tenecteplase relative to the reference agent for patients with acute ischemic stroke.

Phase 3 data show non-inferior efficacy of infliximab biosimilar CMAB008, which was well-tolerated with similar safety to its reference product.

Investigators identify factors that may affect the probability of diagnosis in an evaluation of over 13,500 families with probands with severe developmental disorders.

At months 6 and 12, the proportion of patients who were able to achieve DAS28 remission and EULAR response was similar across treatment arms.

An analysis of survey data from 500 patients with immune-mediated diseases, including rheumatoid arthritis, psoriasis, and IBD, suggests fewer than 1-in-4 patients were knowledgeable on the concept of biosimilars, but were open to learning more and considering use.

Coverage restrictions on biosimilars were observed in highly prevalent diseases but were less likely in biosimilars that generate an annual list price savings of more than $15,000 per patient.

In both the UK and Ireland, a new study found that there were increases in use of biosimilars to adalimumab and other tumor necrosis factor inhibitors for moderate-to-severe psoriasis.

Juliana Reed, MS, believes that there should be legislative incentives and preferred status for lower cost biosimilars in all government programs, with robust competition and accountability for PBMs not to limit access.

Juliana Reed, MS, believes that there needs to be action that addresses the anti-competitive behaviors of pharmacy benefit managers (PBMs) and provides access to all biosimilars.

The March 2023 rheumatology month in review highlights recent data regarding nipocalimab as a treatment option for hemolytic disease of the fetus and newborn and myasthenia gravis, hyperbaric oxygen therapy for fibromyalgia, and the differences among specialties in biosimilar uptake.

The Biosimilars Forum is concerned with the limited access to lower-cost biosimilars, specifically regarding the 8 adalimumab biosimilars set to launch in July, due to pharmacy benefits managers controlling access to 80% of the US market.

Although 75% of gastroenterologists believed that the efficacy of biosimilars and biologics were the same, most clinicians still preferred the brand-name drug option.

Patients who received the biosimilar reported early and significant improvements in areas of pain, NSAIDs requirement, and function.

No significant budget increase was observed in patients with non-radiographic axial spondyloarthritis (nr-axSpA) receiving secukinumab.

Statistical analysis showed no differences between each pairwise comparison of the bevacizumab biosimilars, MB02-SP and MB02-DM, and the reference drug.

Proposed biosimilar AVT04 shows comparable efficacy to ustekinumab.

Clinical remission and clinical response odds, in both induction and maintenance periods, have been consistent over time.

Data from the United Kingdom indicate Amgevita is safe and effective for non-infectious uveitis with non-inferiority to originator adalimumab, but a significant number of patients requested to switch back due to adverse events.

Bruce Feinberg, DO, explained that he and his team at Cardinal Health are constantly examining the market and the various influences that impact biosimilar uptake.

The approval was based on positive results from the phase I pharmacokinetics bridging study, which showed comparable PK and similar safety and immunogenicity of adalimumab 50 mg/mL and adalimumab high-concentration formulation.

In the infliximab reference group, the persistence at month 12 was 94% for Crohn’s disease and 92.8% for ulcerative colitis.

Bruce Feinberg, DO, noted that although patients and providers ultimately understand that a biosimilar should theoretically be just as effective as a biologic, prescribers may still be wary of switching patients to a different product when they have historically experienced an excellent response to the original treatment.

Bruce Feinberg, DO, explained how Cardinal Health used its 2023 Biosimilars Report to better understand the provider's insight on industry changes that are occurring due to the expansion of biosimilars.