Clinical Studies

Herozyme has been developed as a biosimilar to the reference medicine Aldurazyme®, meaning it is designed to have similar effectiveness, safety, and biological activity. The effectiveness and safety of Herozyme were evaluated in a Phase III clinical study.

The study was conducted in pediatric patients with MPS I. The design of the study allowed doctors to observe whether Herozyme could maintain the benefits already achieved with the reference medicine.

Clinical data show that Herozyme provides similar effectiveness, biological activity, and safety to the reference laronidase, supporting its use in the long-term management of mucopolysaccharidosis type I.

Effectiveness Results

uGAG

uGAG

After treatment, mean uGAG levels were similar for Aldurazyme® (220.47 ± 177.13 CPC units/g creatinine) and Herozyme (270.02 ± 111.55 CPC units/g creatinine). No clinically meaningful worsening or rebound increase occurred after switching to Herozyme.

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Physical Function

Physical Function

At week 12 on the reference treatment, the average 6-minute walk distance was 328.22 meters; at week 24 on Herozyme, it was 360.20 meters, an improvement of about 30 meters, showing disease stabilization and no loss of function.

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Lung Function

Lung Function

At week 12 (on reference treatment), mean predicted FVC was 57.50%; at week 24 (on Herozyme), it was 70.56%. This shows maintained respiratory function with numerical improvement consistent with continued enzyme replacement therapy.

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Enzyme Activity

Enzyme Activity

Both Herozyme and Aldurazyme® showed the same pattern: enzyme activity was undetectable before infusion, peaked immediately after, then declined at 30 and 90 minutes, demonstrating similar behavior in the body.

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Safety Results

• A total of 30 adverse events were reported during the study
• Most events were mild to moderate (Grade 1–2)
• The most common event was nasopharyngitis
• Mild infusion-related reactions occurred in both treatment periods
• Serious adverse events were related to underlying disease, not the study drugs

Overall:

• Adverse events were reported in 58.3% of patients during reference treatment
• And 50% during Herozyme treatment

No new or unexpected safety concerns were identified, and the overall safety profile of Herozyme was comparable to the reference medicine.

Dosing and Administration

The dosing schedule for Herozyme is identical to the reference product, supporting clinical interchangeability.

What These Results Mean

• Herozyme maintained disease control after patients switched from the reference medicine
• Key biochemical and clinical measures remained stable
• Effectiveness and safety were comparable to Aldurazyme®
• The study supports Herozyme as a reliable alternative for ongoing treatment of MPS I