Tuesday, August 26, 2014

Doctors Take Sides on Biosimilar Naming Issue

Doctors have officially taken sides in the naming rights battle for biosimilars.  In a recent letter to the FDA, a group of physicians has taken the stance that biologic and biosimilar drugs should in fact have unique names.  This letter comes weeks after another piece of mail showed up at the FDA headquarters requesting that the agency not require distinct names for the two types of drugs.  The lobbying is part of a struggle between biologics manufacturers who want to protect their brand equity by requiring separate names and potential biosimilar manufacturers wanting to piggy back off that equity by using the original drug names for their products.

The letter, signed by 23 different physicians, claims that no matter how similar drugs might be, they can cause different reactions among patients with similar diagnosis’ and physical traits.  Distinguishing between the drugs is key and the group feels similar names could get in the way of that.   

Biosimilar naming: Doctors have  drawn a line in the sand“A biosimilar will only be similar, but not identical to the reference product for the foreseeable future. Distinct nonproprietary names will help to alert physicians that each product, while safe and effective, may differ slightly,” the group writes to the FDA.  “Rather than deter physicians from prescribing these products, we believe that allowing physicians to know the exact product that they are prescribing will increase confidence, thus encouraging more robust utilization of biosimilars than may develop without this transparency.”

A recent survey found that in the Europe (where a robust biosimialr market already exists), 61% of physicians prescribing biologics or biosimilars were of the understanding that if two products shared an international non-proprietary name, they were approved for all of the same indications. 

Other lobbying efforts on this policy include a number of petitions submitted to the FDA over the last few weeks.  While the organization has been mum on a possible decision, the market may push their hand sooner rather than later.  Two drug makers are already seeking regulatory permission to sell certain medications meaning that at least one biosimilar could become available next year. 

Until then, the letters and petitions will likely continue to fill the mailboxes at the FDA’s headquarters.

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