Industry Players Reach Compromise on Biosimilar Substitution

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Reference product manufacturers and trade groups support automatic medication switches in new biosimilar “compromise” terms.

Although no biosimilars have been approved in the US yet, many state legislatures have already been considering whether or not they would allow interchangeable biologics to be automatically substituted at the pharmacy.

The original plan in many states was to require that the prescribing physician be notified of a pharmacist’s substitution prior to substitution, among other requirements, such as pharmacist record-keeping and patient notification. Although legislation has failed to pass in most states, five states (Florida, North Dakota, Oregon, Utah, and Virginia) have enacted laws specifying the circumstances under which pharmacists can substitute biosimilars for reference products.

Now, some biotechnology companies have agreed to approach state legislature with the same plan for biosimilar substitution. This scheme will allow pharmacists to automatically substitute biosimilars for biologics and then notify all relevant parties of the medication change. An Amgen spokeswoman told the Wall Street Journal that “The language adopted by the coalition has progressed by placing an appropriate emphasis on electronic technology to ensure accurate medical records, while creating a clear pathway for the substitution of interchangeable biological products.”

The compromise language decrees that “within a reasonable time following the dispensing of a biological product, the dispensing pharmacist or the pharmacist’s designee shall communicate to the prescriber the specific product provided to the patient.” This communication would come in the form of an electronic database, unless this entry method was not available; in this case the pharmacist would notify the physician of the change by another method.

GPhA said in a statement that the compromise legislation “is a vast improvement over 2012 language that originally erected numerous barriers to the automatic substitution of interchangeable biologics. These barriers included pre-dispensation physician notification and written patient consent.”