Lower cost complex drug treatments

Biosimilars are complex large molecule injectable drugs in the same way as innovator biologics – the original reference products they are based on. They are targeted therapies based on proteins and antibodies that typically work by interacting directly with cells.

Biologic drugs have been around for approximately 40 years and have been highly successful in enabling patients to manage complex medical conditions such as autoimmune diseases, as well as treating and curing rare and life-threatening diseases including cancers.

The concept of a biosimilar is to base the structure and function of the drug on an existing (reference) biological drug. They are not identical but extremely similar. The reference biologics have proven efficacy in areas of medical need, but their patent protection has typically expired.

Biosidus has developed and commercialized nine biosimilar products in the last 30 years, with all work being done in-house by the talented teams at our facilities in Argentina. Our R&D team is currently advancing a 10th biosimilar – Agalsidase beta for the treatment of Fabry disease – which is in Phase III clinical trials and scheduled to be commercially launched in 2025.

Biosimilars have the same safety profile as all biological drugs. Equivalence between the reference product and the biosimilar must be measured according to a thorough comparability exercise. The goal is to demonstrate that inevitable subtle differences between the two do not have an impact on the risk-benefit ration. Success here leads to an assertion that the active substance in both medications are essentially the same.

They are subject to the similar regulatory scrutiny, with scope for a few efficient shortcuts for a biosimilar. Approval is supported by strict medical and scientific evidence, and regulatory authorities apply the same criteria to both, according to the level of demand within the risk-benefit ratio. Once equivalence is established and the product is approved by regulatory authorities, a biosimilar is regarded in the same way as any other biological drug.

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