Mylan has a combined portfolio of 16 biosimilar and insulin analog products in development, which is one of the industry’s largest and most diverse portfolios. Biosimilars play an important role in Mylan’s commitment to setting new standards in healthcare by offering quality alternatives to more costly therapeutic options and increasing access to treatment for patients.
Biosimilars are products deemed highly similar to an already FDA-approved product known as a biological reference product and have no clinically meaningful differences in terms of safety and effectiveness from the reference product. These highly complex and often expensive therapies are used in diseases like cancer, multiple sclerosis, rheumatoid arthritis and diabetes. Biosimilar development uses the latest state-of-the-art analytical and biotechnology methods, including some that may not have been available at the time the reference product was first approved.