Regulatory basis of biosimilar medicinal products: Need for harmonization

When a biopharmaceutical product patent expires, other manufacturers can produce copies of the original drug. These products, called biosimilars (follow-on biologics in the USA) are similar but not identical to the innovator drug due to the protein nature complexity.

The article reviews the European regulatory basis for biosimilars approval and marketing. The current situation at USA is also analized as well as the harmonization perspectives at global level.