Biopharmaceuticals and biosimilars are very similar. However, they are not identical. The European Medicines Agency only certifies pharmaceutical equivalence for both preparations. This means that innovator products and biosimilars contain the same active ingredient in the same molar amount, are given in the same application form, meet the same quality standards, and have an identical safety profile.

However, the respective characteristics in terms of colour, shape and taste may differ. Differences are also permitted in the manufacturing process and release behaviour of the active substance.