Sound science is key in biosimilars debate

Contrary to the assertions of Jessica Stone in her Sept. 15 blog post, the issue of naming for biosimilars is not about competition, it is a matter of sound science.

There are fundamental scientific considerations at the heart of the larger debate regarding biosimilars. Distinguishable names for biological products developed by different manufacturers must be required to prevent inappropriate substitution, facilitate post-market surveillance, ensure accurate attribution of adverse events to the correct product, and support tracing of products in the event of the need to recall. 

{mosads}This viewpoint is not unique – leading scientific and regulatory authorities in the United States and around the world have universally determined that it is inappropriate to treat biosimilars like generic drugs because biosimilars are not the same as their reference biologics. Independent names for different products are necessary because even minor differences between innovator and biosimilar products can lead to real health outcome differences for patients.  And, contrary to Ms. Stone’s assertions, taking these precautions doesn’t threaten the success of a biosimilar industry, as biosimilars in other countries that use distinguishable brand and nonproprietary names have achieved a robust share of the overall market. 

We will continue to work with the FDA and other stakeholders to ensure that patients are protected and science prevails in the debate over naming.

Greenwood, a former Congressman representing Pennsylvania, is the president and CEO of the Biotechnology Industry Organization, the world’s largest biotechnology trade association.