Примери за biosimilar

• I am thinking in particular of the definitions of medicinal product, generic medicinal product and biosimilars.

• This biosimilar products are usually protected by surrounding patents which may also delay the time for their production.

• The product is the first biosimilar or biogeneric of the above mentioned drug.

• Originally the complexity of biological molecules led to requests for substantial efficacy and safety data for a biosimilar approval.

• 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.