A rose is a rose is a rose, unless it is a biosimilar. Then it may be something else. At least that is the contention of biologicsmakers who want biosimilars to have completely different names than the biologics they will so closely resemble. It is the newest fight to break out on the biosimilars frontier as the U.S. prepares for new rules governing the high-potential products.
Naming is a patient safety thing, according to two of the key pharma trade groups PhRMA and BIO. Pharmalot says they sent a letter last month to FDA Commissioner Margaret Hamburg saying that as a matter of "pharmacovigilance," it is essential that each biologic have a "unique non-proprietary name." "Because a biosimilar or interchangeable biological product is highly similar to, but not the same as, its respective reference product, it would be inappropriate, from a patient safety perspective, to permit the use of the same name for biological products that are not the same," according to the letter, to which Pharmalot links.
Potentially complicating the nomenclature a little more, the groups suggest, "In the event that both biosimilar and interchangeable products are available for a single reference product, the need for unique names for all biological products becomes even more important," the letter says.
Not so fast, responds the Generic Pharmaceutical Association which points out in its own letter that the "same INN (international non-proprietary name) has been given to biosimilars in other regions and to different recombinant and naturally derived products from different manufacturers, even if there were slight differences." It makes no sense to give different names to something that are supposed to be "pharmacologically identical."
While the arguments appear to be over patient safety and medical confusion, they are also about money. Due to the heavy cost of development, biosimilars will be offered at a discount of around 10% to 20%, but without the drastic markdowns that obliterate a small molecule's retail value in months. Everyone is jockeying to get the most out of what they develop.
The fight over naming rights is not the only one going on. Abbott Laboratories ($ABT) has challenged the legality of the biosimilar provision in the Affordable Healthcare Act as it tries to protect its biologic, Humira. Last year the rheumatoid arthritis drug was the company's top-selling med with about $3.4 billion in revenue.
- read the Pharmalot story
FDA maps out long-awaited rules for the biosimilars business
Abbott stands alone in challenge to biosimilars law