Featuring: Suhasini Sharma, Sciformix Corporation
The number of biosimilars on the market continues to grow in the United States, but safety concerns about them remain.
“I think the theoretical concerns are really around the fact that the molecules can’t be made exactly the same as the reference product because of the complexity and size of the molecule,” said James G. Stevenson, PharmD, FASHP, Professor of Clinical Pharmacy at the University of Michigan College of Pharmacy.
The manufacturing process for a biosimilars is proprietary, which means it won’t be exactly the same, potentially creating safety concerns, he said.
For example, while there have been no incidents with biosimilars, there have been cases with biologics in general where small differences in the manufacturing process have led to immunogenicity problems, Stevenson noted. These problems could result in a decrease in efficacy of the drug through development of neutralizing antibodies or could result in adverse effects, he said.
Suhasini Sharma, MD, Director of Medical Affairs for Sciformix, a company that provides Safety and Risk Management process, technology, and consulting services, said that because there is limited research and experience using biosimilars there is still a lingering question of whether biosimilars will cause long-term adverse reactions.
“In the long run, what we need to decide is: Are there any unique or adverse effects or issues related to a particular biosimilar product that are different from the reference product?” she said.