Dr. Richard Dolinar, a Glendale, Ariz.-based physician who is ASBM’s chairman, noted that chemical medicines are small molecules that treat the symptoms of illness or disease, but that some biologics, which he described as “huge, engineered structures,” can get to the pathways of illnesses like arthritis or cancer.
“A biologic product is not a matter of chemistry but is actually farming with molecular structures,” Dolinar said. “We grow these products at the molecular level, and they are very sensitive to their surroundings. They must be closely monitored during the manufacturing process. If they are changed slightly, there is a chance it will trigger the body immune system and blunt the drug’s effect.”
One reason biosimilars cannot be similar to one another let alone to the referenced product is that the manufacturers will be using different cell lines. “They can make them similar, but not identical,” Dolinar said. Stating that patient safety is of paramount importance, Dolinar stressed the need for pharmacovigilance, which is the detection, assessment, understanding, and prevention of adverse effects – particularly long-term and short-term side effects – of medicines. He indicated that:
- biosimilar products must have unique names so that they can be tracked and traced;
- labeling must be transparent; and
- decisions made between physicians and patients must be respected, and pharmacists wishing to change the drug prescribed to a biosimilar or to a different biosimilar should contact the physician first.
Dr. David Charles, a neurologist who was representing the Alliance for Patient Access, agreed with Dolinar that distinct names for biosimilars are necessary. “The whole manufacturing process for biosimilars is so complex that if a patient gets a bad reaction from a drug, we have to be able to find out what was taken,” Charles said. “If we don’t know, then a whole batch of drugs would have to be considered as potentially bad, when it might be that just one company had a manufacturing problem with its biosimilar product.”
