Biosimilars are biological drugs (also called biologics) that are a copy of an existing biological brand-name drug. As biological drugs contain complex protein APIs whereby the manufacturing process determines the composition of the end product (“the process is the product”), they are referred to as biosimilars rather than generic drugs. This serves to make clear that the drug is similar but not the same.

Main features of biosimilars:

• Similarity to the brand-name drug: Biosimilars are similar to the original biologics in terms of their molecular structure, pharmacological properties, efficacy and safety. However, they are not exact copies, as biologics are produced using living cells, which involves a certain degree of variability.
• Manufacturing process: During the production of biosimilars, living systems (e.g. cell lines) and processes that are similar but not identical are used, which may lead to some differences between the final product and the original biological drug.
• Marketing authorization and testing: Biosimilars require strict regulatory marketing authorization. The approval process involves demonstrating biosimilarity (German translation: Biosimilarität) with the brand-name product through a series of comparative studies, including pharmacodynamic, pharmacokinetic, immunogenic and clinical studies.
• Cost and affordability: Biosimilars are generally less expensive than brand-name products, which makes them an important factor in reducing healthcare costs.
• Therapeutic use: Biosimilars are used to treat the same diseases as the biological brand-name drugs, including but not limited to cancer (German: Krebs), autoimmune diseases, chronic inflammatory diseases and diabetes.
• Pharmacovigilance (German translation: Pharmakovigilanz): Biosimilars require active post-marketing surveillance and data collection to monitor their safety and efficacy for the entirety of their use period.

In contrast to conventional generic drugs, where the active pharmaceutical ingredient is an exact chemical copy of the one in the brand-name drug, biosimilars cannot be exact copies due to the complexity and variability of the living organisms used to produce them. Therefore, the manufacture and marketing authorization of biosimilars requires appropriate regulations and rigorous testing to ensure that they are safe, effective and bioequivalent to the biological brand-name product.

Biosimilars are used to treat a variety of diseases, including cancer, rheumatoid arthritis and psoriasis. They can provide more affordable treatment options compared to the more expensive brand-name biologics.

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