Juliette Gagliardi
Junior Researcher
Generics and biosimilars in Italy - Statistics & Facts
The worldwide sales value of generic drugs has constantly increased over the last decade and is expected to reach almost 700 billion U.S. dollars in 2033. Among the main reasons for the expansion of this market is the competitive cost of generics compared to branded drugs. Generics are drugs having the same pharmaceutical form as branded medications, as well as qualitative and quantitative composition in terms of active substances. As it is globally, the market for generics is also increasing in Italy. In 2023, generics’ share of the pharmaceutical market value in Italy was close to 16 percent and of the market volume almost 23 percent.
Generics: expenditure and consumption
Although generics are duplicates of branded drugs, Italian citizens spent over one billion euros on brand (off-patent) drugs instead of the generic equivalent. Over the last few years, the share of net expenditure on generic drugs has overall increased, especially in the northern regions where this share reached 33 percent. Among the so-called class A generic drugs, for which the cost is covered by the Italian National Healthcare Service, pantoprazole was the most consumed active ingredient. When considering the class C generic drugs, for which the cost rests entirely on private citizens, lorazepam was the most consumed active ingredient.Biosimilar drugs: consumption and market value
Unlike generics, biosimilars are drugs that are similar in terms of quality, effectiveness, and safety to the biological drug in consideration, and they are not subject to patent coverage. In other words, biosimilars are not direct substitutes like generics are. In Italy, the share of the consumption of biosimilar products has increased steeply in the last few years, from 13 percent in 2016 to 49.2 percent in 2023. Indeed, in 2023, around 56 million units of biosimilar drugs were consumed. With 70 percent, Marche was the Italian region with the highest share of biosimilars consumed if a biosimilar alternative was available on the market.
