Biosimilars

The investigation of 11 alternative DMARD therapies in combination with methotrexate shows a lack of economic attractiveness compared with the standard of care.

An analysis suggests biosimilar bevacizumab was safe and effective over 6 weeks with noted improvement in BCVA and OCT parameters for patients with macular edema.

After rituximab treatment, patients experienced a reduction of symptoms, corticosteroid administration, and median corticosteroid dose from baseline.

An analysis based in Japan suggests ranibizumab biosimilar is dominant to other anti-VEGF treatments in patients with nAMD in both treat-and-extend and PRN regimens.

The biosimilars month in review highlights infliximab biosimilars data presented at Digestive Disease Week (DDW) 2023, California’s proposed plan to produce and market biosimilar insulin at production-equivalent prices, and new FDA approvals.

The analysis of the XPLORE trial suggested XSB-001 showed biosimilarity to reference ranibizumab as assessed by BCVA improvement at 8 weeks.

The biosimilars were equivalent with the biologic regarding both ACR20 response achievement and change of Health Assessment Questionnaire-Disability Index (HAQ-DI) scores at month 6.

The approval was based on a comprehensive assortment of studies which showed adalimumab-aaty was comparable to the reference product, adalimumab.

The US Food and Drug Administration (FDA) has approved the adalimumab-adbm (Cyltezo) autoinjector pen ahead of the July 1 commercial launch.

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.