Biosimilars Connect
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Did you know?

A 2023 IQVIA analysis estimated that biosimilars approved through 2022 generated cumulative US healthcare savings of $36 billion over their first five years on the market. A systematic review of 19 real-world switching studies (n=33,284 patients) published in JAMA Internal Medicine found no clinically meaningful differences in efficacy, safety, or immunogenicity outcomes when patients were switched from originator biologics to biosimilars in inflammatory diseases, oncology, and gastroenterology — supporting the safety of non-medical switching programs.

NCCN Guidelines
Discussion question

In your practice, how are you navigating biosimilar switching conversations with patients who are stable on originator biologics — and what institutional policies are you using to drive appropriate biosimilar adoption?

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Natalizumab and Tyruko (natalizumab biosimilar) for treating highly active relapsing-remitting multiple sclerosis after at least one disease-modifying therapy: a systematic review and economic model. - PubMed

Natalizumab and Tyruko (natalizumab biosimilar) for treating highly active relapsing-remitting multiple sclerosis after at least one disease-modifying therapy: a systematic review and economic model. - PubMed

Source : https://pubmed.ncbi.nlm.nih.gov/42579606

Natalizumab and its biosimilar show similar effectiveness in relapsing-remitting MS, but lack specific data for highly active cases. Not cost-effective compared to other treatments.


Natalizumab and its biosimilar show similar effectiveness in relapsing-remitting MS, but lack specific data for highly active cases. Not cost-effective compared to other treatments.

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Biosimilar Nivolumab-Based Combination Therapy in Advanced Oral Cavity Squamous Cell Carcinoma: A Real-World Case Series of Five Patients. - PubMed

Biosimilar Nivolumab-Based Combination Therapy in Advanced Oral Cavity Squamous Cell Carcinoma: A Real-World Case Series of Five Patients. - PubMed

Source : https://pubmed.ncbi.nlm.nih.gov/42559246

Explore the management potential of OMCT with low-dose nivolumab in advanced oral cavity SCC, based on a real-world case series of five patients.


The combination of OMCT with low-dose nivolumab in advanced SCCHN is being explored in a case series of five patients, with outcomes comparable to existing treatments. Disease Condition: Advanced Oral Cavity SCC. Specialty Focus: Pharmacy.

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Diagnostic accuracy of magnetic resonance enterography and intestinal ultrasound for treatment response assessment in Crohn's disease (MANTRA): protocol for a multicentre, non-randomised, multiple-arm, prospective cohort comparison study. - PubMed

Diagnostic accuracy of magnetic resonance enterography and intestinal ultrasound for treatment response assessment in Crohn's disease (MANTRA): protocol for a multicentre, non-randomised, multiple-arm, prospective cohort comparison study. - PubMed

Source : https://pubmed.ncbi.nlm.nih.gov/42509009

A study compares MR enterography and intestinal ultrasound for accuracy in Crohn's disease treatment response assessment.


MR enterography and intestinal ultrasound are being compared for their accuracy in assessing Crohn's disease treatment response in an ongoing study.

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Biosimilar switching in clinical practice: real-world efficacy, immunogenicity evidence, and strategies for optimizing adoption

Biosimilars are highly similar versions of approved reference biologics with no clinically meaningful differences in safety, efficacy, or immunogenicity. As patents expire across TNF inhibitors, anti-VEGF agents, and oncology monoclonal antibodies, biosimilars are reshaping prescribing across specialties.

A 2025 systematic review and meta-analysis of 10,812 IBD patients found comparable clinical remission in Crohn's disease and ulcerative colitis after biosimilar switching, with no significant difference in anti-drug antibody incidence versus originator therapy (OR 0.96; 95% CI [VERIFY]) and similar safety profiles. In ophthalmology, anti-VEGF biosimilars show equivalent visual acuity outcomes in pivotal trials, with 20–40% cost reductions versus originators. Despite robust evidence, adoption barriers persist, including prescriber unfamiliarity, patient nocebo effects, and variable formulary policies. Structured communication frameworks and transition protocols are critical to building confidence across prescribers and patients.

Rheumatologists, gastroenterologists, oncologists, ophthalmologists, and pharmacists managing patients on biologic therapies will benefit from peer discussion of switching evidence, immunogenicity monitoring, communication strategies, and the rationale for biosimilar adoption.

What clinical or patient-specific factors guide your decision to initiate a biosimilar versus originator biologic, and how do you counsel patients on switching to address nocebo-related concerns? How do you approach immunogenicity monitoring when transitioning patients to biosimilars, and does your surveillance approach vary by disease area or therapeutic class?