Because of their size and structural complexity, and their production using living cell systems, biosimilars require very significant time, effort and expertise, both in their development and in their subsequent production.
The central principle in the development of any biosimilar medicine is its high similarity with an established reference biopharmaceutical. To achieve regulatory approval, the producer of the biosimilar must conclusively demonstrate that its quality, safety and efficacy are entirely comparable to the reference drug.
The time it takes to complete the development of a biosimilar is, on average, seven to eight years. Their development involves a series of stages which are both necessary and complex. Because of the great challenges involved in developing and producing Biosimilar medicines, there are only a very limited number of companies in the world with the know-how and capabilities to develop and produce these new-generation medicines, particularly when it comes to meeting the strict regulatory standards of the world’s highly regulated markets.