Amgen, the pharmaceutical company that produces Enbrel in the United States, still has patent protection over the drug, meaning other companies cannot yet make biosimilar versions of the medication that tend to be less expensive. There is no Enbrel biosimilar (comparable to a generic) yet
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We believe that it is reasonable to require an enhanced disclosure to the patient who may be prescribed one of these drugs that this molecule is not as well-characterized as drugs that would normally be dispensed to patients, and the patient needs to understand that there may be a higher risk profile, and they should only be taken under the care of a physician, he said
