Pharmaceutical companies are gearing up for a new “breed” of drugs to hit the U.S. market, possibly as soon as 2015.
Called biosimilars, these drugs mimic another biological drug, but aren’t exactly the same. They’re big in Europe, as the saying goes, but not yet available here. Federal regulations still being drafted for the drugs are expected to identify certain biosimilars that are deemed to be “interchangeable.” Some state lawmakers want to make it easier for patients to get such drugs, as long as pharmacists notify doctors and keep extensive records.
Virginia Thomas has lupu and takes a biological drug called Benlysta to treat her disease. She says the notification requirement is a good idea.
“The thought of having my Benlysta substituted for a biosimilar, particularly without physician approval or my approval, is a scary one,” Thomas said.
Pharmacist groups say such notifications would be overly cumbersome.
Pennsylvania law doesn’t yet address biosimilars, so when they become available, the only way a patient could access them would be if a doctor specifically prescribed them.