What Are They?
As biologic drugs like insulin approach the end of their patent life, biosimilar versions are being developed and approved to help increase competition and access to treatment. But what exactly are insulin biosimilars? A biosimilar is a biologic medical product that is highly similar to an already approved biologic reference product, known as the original innovator biologic. Biosimilars may offer more affordable options for patients, while maintaining the same quality, safety and efficacy as their reference products.
Approval Process for Insulin Biosimilars
All Insulin Biosimilars must go through a rigorous approval process to ensure they meet rigorous standards for safety, purity and potency. For approval in the United States, biosimilars must demonstrate no clinically meaningful differences from the original biologic in terms of safety, purity and potency. Extensive analytical, nonclinical and clinical studies are required to prove biosimilarity. Clinical trials evaluate pharmacokinetic and pharmacodynamic properties as well as immunogenicity and safety. Manufacturing processes also undergo thorough review and inspection to ensure consistent production according to current good manufacturing practices. This thorough approval process helps provide assurances to patients and physicians.
Available Options
Currently, the only biosimilar versions of insulin available in the United States are follow-on versions of insulin glargine, also known as Lantus. The first insulin glargine biosimilar, called Semglee, was approved by the FDA in 2019. Other versions from companies like Viatris and Civica Rx have since gained approval as well. These biosimilars are highly similar to Lantus and provide additional treatment options for diabetes patients. Availability of lower-cost biosimilar insulins could help more patients gain access to the treatment they need. However, uptake has been slower than expected thus far.
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