Biosimilars

Pharmacokinetic parameters and bioequivalence were comparable among patients receiving reference tocilizumab and its proposed biosimilar, HS628.

The empagliflozin reference drug and its biosimilar (CKD-370) demonstrated bioequivalence, and both treatments were well-tolerated among patients.

The biosimilar month in review highlights the July 1 launch of 7 adalimumab (Humira) biosimilars in the US and the cost-saving potential of increased biosimilar availability.

Stephen Pagnotta, executive director and Biosimilar commercial lead at Boehringer Ingelheim, discusses the significance of the US launch of biosimilar adalimumab-adbm and its interchangeable designation.

The estimated total savings was over €243 million for TNF, with over €166 million ascribed to reductions in treatment costs for rheumatic diseases.

Patients who completed the survey were significantly more likely to achieve 12-month persistence on adalimumab biosimilar SB5 when compared with non-respondents.

A single-center retrospective study is offering clinicians insight into the effects of biosimilar infliximab use on weight, height, and BMI trajectories in pediatric patients with inflammatory bowel disease.

The limited impact of past policy interventions to increase biosimilars uptake in Belgium suggests a need for individualized, proactive measures.

Results showed even at a 55% discount, the biosimilar adalimumab-atto still costs more than double the launch price of reference adalimumab.

The main pharmacokinetic parameters were comparable between the tocilizumab reference and the biosimilar cohorts.

Juliana Reed, MS, predicts what the future holds regarding biosimilar access in the United States.

Juliana Reed, MS, explains the factors decision-makers need to consider to ensure lower-cost adalimumab biosimilars reach millions of patients in the United States.

Although the recent launch of 7 adalimumab biosimilars should lead to cost savings and better access to medication, the role of pharmacy benefit managers raises concerns for Reed and her team.

The use of infliximab, adalimumab and etanercept following biosimilar entry increased by 88.9%, 22.4%, and 14.6%, respectively.

The biosimilar month in review highlights ranibizumab biosimilars for the treatment of nAMD, Optum Rx’s decision to recognize subcutaneous adalimumab-adbm as a preferred brand, and the cost-saving benefits of biosimilars for patients.

The citrate-free high-concentration formulation and citrate-containing low-concentration of biosimilar adalimumab-bwwd are now available to patients living in the US.

Significant improvements seen in hematologic parameters, visceral volumes, and plasma biomarkers in patients with Gaucher disease, suggesting its potential as an alternative therapy, particularly for those who cannot access enzyme replacement therapy.

Optum Rx announced it will place the biosimilar adalimumab-adbm (Cyltezo) injection on its commercial formulary as a preferred brand.

A systematic review and meta-analysis found no significant differences in visual and anatomical outcomes between ranibizumab biosimilars and reference ranibizumab in eyes with neovascular AMD.

The rituximab biosimilar rixathon was linked to the the lowest average annual cost per patient across 6 indications among all biosimilars.

Combination methotrexate plus bDMARDs, bsDMARDs, and tsDMARDs provided .009 to .33 quality-adjusted life years gained with additional costs of $15,957 to $60,722 when compared with standard of care.

All primary endpoints evaluating pharmacokinetics were achieved and immunogenicity and safety were comparable across treatment arms.

Amgevita and Idacio exhibited higher rates than methotrexate at both week 24 and week 52 suggesting adalimumab biosimilars provided superior treatment persistence among patients with moderate-to-severe psoriasis.

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.