Signs Point to Better Market Conditions for Biosimilars

Omar Hafez, MS, MBA
Published: Thursday, Sep 05, 2019
Omar Hafez, MS, MBA

Omar Hafez, MS, MBA

The story of biosimilars in healthcare is a cautionary tale for all of the many stakeholders― manufacturers, distributors, payers, providers, and patients―who stand to benefit from these promising alternatives to biologics. The danger for the biosimilar market is that the healthcare landscape could become so challenging for manufacturers that they lose interest in developing these drugs, resulting in an unpleasant fate: a future with no biosimilars. Fortunately, we aren’t there yet. Even though many challenges must be overcome before widespread adoption can occur, there is still much promise on the horizon for biosimilars.

Despite the advantages biosimilars offer, they face an uphill battle. The FDA is moving toward clearer language on policy for bringing biosimilars to market; hopefully, that will remove some of physicians’ lingering doubts about efficacy and safety. Although these new policies are welcome, they are not sufficient to drive widespread adoption, because additional forces at play are causing manufacturers to reevaluate their biosimilar investments.

Table. Affordable Prescriptions for Patients Act of 2019 (Introduced May 9)13 (Click to Enlarge)

Physicians have been apprehensive about adopting biosimilars but perhaps not for the reasons one would expect. Obviously, a clinical comfort level must be met before a physician will write a prescription, and that barrier is higher for a therapeutic oncology biosimilar than it is for a supportive-care drug such as filgrastim-sndz (Zarxio) or pegfilgrastim-jmdb (Fulphila). However, physicians also want assurance that they will be supported if they transition to a biosimilar. For instance, will the biosimilar manufacturer provide the same patient assistance services as the biologic? Will product supply be as reliable? Will payers cover the biosimilar? Will the manufacturer have representatives available to answer questions? All these factors can inhibit adoption.

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