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Insulin glargine biosimilars: real-world and switching evidence

What the evidence shows

Evidence intelligence

1published study

1trial with repeated switching

1disease covered

1product covered

Studies found1 study, the trial built for the FDA interchangeability decision on Semglee.
The trialPeople with type 1 diabetes who had spent a year on Lantus were switched to Semglee, back to Lantus and to Semglee again over 36 weeks, or kept on Lantus. HbA1c change was equivalent, and insulin dose, low blood sugar events and antibodies were similar.
Products with evidenceSemglee. No published switching study yet in this register for Rezvoglar, Lusduna or the Indian products.
What is missingNo study from India or the Gulf, where most biosimilar insulin glargine is used. Nothing in type 2 diabetes. No study from routine care.

Studies

Disease

Product

Trials with repeated switching

Patients switched between Lantus and the biosimilar more than once, with a control group that stayed on Lantus. FDA interchangeability decisions rest on this design.

Study	Disease	Switch	Products	Patients switched	Follow-up	What the authors report
Blevins 2020 Diabetes Obes Metab 2020;22(3):365-372 Multicentre	Type 1 diabetes	Repeated switches between biosimilar and reference (biosimilar weeks 0 to 12, reference 12 to 24, biosimilar 24 to 36)	Semglee	64	36 weeks	Change in HbA1c from baseline to week 36 equivalent between the switching and reference sequences; fasting glucose, insulin dose, immunogenicity and adverse events including hypoglycaemia similar.

Blevins 2020Diabetes Obes Metab 2020;22(3):365-372

DiseaseType 1 diabetesSwitchRepeated switches between biosimilar and reference (biosimilar weeks 0 to 12, reference 12 to 24, biosimilar 24 to 36)ProductsSemgleePatients64Follow-up36 weeks

What the authors report

Change in HbA1c from baseline to week 36 equivalent between the switching and reference sequences; fasting glucose, insulin dose, immunogenicity and adverse events including hypoglycaemia similar.

No study matches this selection.

Switching evidence is what regulators, tender committees and formulary boards ask for before a change of product. EvySaif prepares interchangeability and switching dossiers and designs real-world studies for biosimilar programmes. Regulatory strategy consulting

Sources

S025Peer-reviewed journal articles on switching between biosimilars and the reference product; the study link on each row opens the paper Primary (published study)

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Data current to September 2026.