Creating a biosimilar requires skilled scientists to conduct steps in a laboratory that require a high level of precision. The first step in developing a biosimilar is to transfect living cells with DNA, meaning to insert the genetic “instructions” for each new clone (version of the cell) to produce the amino acid sequence of the biologic. Once thousands of versions of the biologic are created, each by a different clone, scientists evaluate them to identify the clone
that is most similar to the reference product. Once that clone has been selected, the manufacturing process is developed to enhance the level of similarity between the biosimilar and the reference product. This process will also be the platform for creating a large enough quantity of the biosimilar to supply patients with medicine. Once this process has been defined, non-clinical and clinical testing can occur. Clinical testing of biosimilars
often involves two stages: a first stage in healthy volunteers or patients to test that the body processes the biologic in the same way as the reference product (i.e., pharmacokinetics and pharmacodynamics) and a second stage in patients to test that the biosimilar works with a similar level of efficacy and safety as a reference product.