Biosimilares

Biosimilares are biological medicines that are highly similar to an already approved biological medicine, known as the reference product. They are not identical, but they are similar enough that there are no clinically meaningful differences in terms of safety, purity, and potency. The development and approval process for biosimilares is rigorous and involves comparing the biosimilar to the reference product through extensive analytical, non-clinical, and clinical studies.

The primary goal of biosimilares is to increase patient access to important biological therapies. By offering a more affordable alternative to the reference product, biosimilares can help reduce healthcare costs and allow more patients to benefit from these often life-saving treatments. This can be particularly important for chronic diseases or conditions requiring long-term treatment with biological medicines.

The regulatory pathways for approving biosimilares vary by region, but generally require a high degree of scientific evidence demonstrating the similarity between the biosimilar and the reference product. Regulatory agencies assess the manufacturing process, structural and functional characteristics, and clinical efficacy and safety data. Once approved, biosimilares can be prescribed by healthcare professionals, and in many cases, they are interchangeable with the reference product, meaning patients can switch between them without a change in treatment outcome. The introduction of biosimilares is a significant development in the pharmaceutical landscape, promoting competition and potentially lowering drug prices.