Distinguishable biosimilar names required to give rare disease patients optimum levels of care.
In a letter to the US Food and Drug Administration, the National Organization for Rare disorders, has urged the body to take into condieration the impact of biosimilar and bilogic naming policies on the rare disease community.
NORD cites the often complicated medication combinations taken by rare disease patients and claims that non-distinc names for biologics could make it difficult to track patient outcomes. Given the number of doctors that rare disease patients can go through over just a few years, and the unique and less-researched affect of medications on rare disease patients, it is critical that the FDA do not do anything to further complicate the process.
When it comes to biosimilars, whilst NORD expresses their pleasure about the possible discounts for patients that biosimilars may bring, they highlight once again the complicated nature of treatment regimes for rare disease patients. this, coupled with a lack of understanding that surrounds many of the 8,000 rare diseases, could result in serious and unexpected adverse effects caused by the dissimilarities of biosimilars compared to their brand name counterpart. NORD contends distinguishable names for biosimilars would remind physicians, payers, patients, and providers that these drugs have only been granted approval on the basis of similarity, not on the basis of substitution or interchangeability.
Read the full letter below.