0 a drug that is very similar to one that was originally produced by a different company : --
Large European pharmaceutical companies are already selling biosimilars in Europe.
For more complex products, such as inhalers, patch delivery systems, liposomal preparation, or biosimilar products, testing to show pharmacodynamic or clinical equivalence is a more complex challenge.
Originally the complexity of biological molecules led to requests for substantial efficacy and safety data for a biosimilar approval.
The product is the first biosimilar or biogeneric of the above mentioned drug.
This biosimilar products are usually protected by surrounding patents which may also delay the time for their production.
I am thinking in particular of the definitions of medicinal product, generic medicinal product and biosimilars.
