The most repeated phrase in the forums where biosimilar medicines are discussed tends to be the headline hidden behind the question in this post. The ease with which biosimilars are compared to generics has prompted pharmaceutical experts and executives to immediately clarify that biosimilar and generic are not the same.
The explanation why some confusion is generated is simple; a generic is the equivalent in quality, efficacy and safety to a chemical synthesis product, and a biosimilar it is from a biological drug. However, the studies necessary to establish this equivalence in both cases are incomparable. Therefore, the difference lies in the regulatory requirements for the development of one or the other.
Thus, the regulatory journey to demonstrate that a biosimilar is equivalent to a reference biologic it is noticeably longer and more complex than in the case of generics.
This is because reproducing the structural and functional characteristics of a biological drug is more complicated than reproducing a product of chemical synthesis. Part of that complexity is attributable to the inherent variability to biological drugs.
Having clarified this, it is worth insisting that a biosimilar is NOT a genericHence, it is preferable to avoid the term "biogenic" to refer to biological products authorized by the European Commission.
