This week, the Food and Drug Law Institute published a white paper – Biosimilar Nomenclature: Can we achieve the truth, the whole truth, & nothing but the truth? – outlining key considerations around the naming of biosimilars.
Peter J. Pitts, President, Center for Medicine in the Public Interest and Former Associate Commissioner, US Food and Drug Administration, asserts that ‘those who view distinctive biosimilar nomenclature naming as either contrary to safety or anti-competitive are addressing these issues through a single dimension. And it just isn’t that simple.’
Pitts points out several key myths, such as distinguishable naming could confuse providers and patients and have the ‘unintended effect of slowing the uptake of these cost saving drugs.’ The reality is that patient and physician groups are in favor of transparency so that patients know what they’re taking, and the healthcare system can quickly identify adverse events if necessary.
“The scope of patient-focused organizations that have come out in support of distinguishable naming is so broad, it covers virtually every single American family,” writes Pitts.
The four main assertions in the paper include:
• Insist that the FDA require differential nomenclature for all biosimilar products.
• Require physician notification for all patients switched from an innovator medicine to any biosimilar product.
• Develop more robust and frequent pharmacovigilance programs for biosimilars.
• Expand post-marketing surveillance to gain better “real world” perspectives on the therapeutic outcomes of both naïve and switched patients using biosimilar medicines.
Check out the white paper here.