Biosimilars

Rituximab biosimilars, Rixathon and Truxima, demonstrate promise in the treatment of immune thrombocytopenia, with comparable efficacy and safety profiles to the reference product.

During the study follow-up period, 74.5% of switchers and 51.3% of infliximab-naïve patients remained on ABP 710 treatment without a treatment gap.

The primary pharmacokinetic analysis proved equivalence between MSB11022-acetate and adalimumab.

A cross-sectional analysis of Medicare and commercial insurer spending suggests the in-state biosimilar production plan could be substantial in savings even after insulin cost rebates.

A phase 3 trial comparing QL1206, a denosumab biosimilar, to the reference agent has returned results demonstrating the efficacy, safety, and pharmacokinetic equivalency of the biosimilar to the reference agent.

Based on data presented at ARVO 2023, Parikh discusses how anti-VEGF biosimilars may increase both patient and overall healthcare costs.

No statistically significant differences in infusion reaction, serious reaction, or immunogenicity rates were identified between patients switching to an infliximab biosimilar and those who continued treatment on the originator.

No statically significant differences in ESR, CRP, TNF levels, and albumin were observed pre- and post-switch from the infliximab originator to the biosimilar.

Clinical outcomes of lab values were not statistically different in changes from baseline to 12 months between children with inflammatory bowel disease initiated on the TNF originator or biosimilar.

Most patients remained on infliximab biosimilars during the follow-up period and the number of switches was not independently linked to infliximab persistence after adjusting for confounders.

The biosimilars month in review highlights the positive safety and efficacy data of 3 biosimilars used to treat rheumatic diseases, gastroenterologists discuss the risks and benefits of prescribing biosimilars to their patients, and physicians emphasize the importance of patient education.

There remains a need for more biosimilars in gastroenterology.

The Inflation Reduction Act contains a provision that boosts reimbursement to physicians to encourage the adoption of biosimilars and allows biosimilars to have lower list prices, benefiting patients' out-of-pocket costs.

Data from a secondary analysis of a randomized controlled trial provide an overview of the cardiovascular safety of trastuzumab biosimilar SB3 compared to the reference agent.

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.