Biosimilars are knocking at our doors, and they certainly have a lot to say. Biosimilar products are biological products that are approved based on showing that they are highly similar to FDA-approved biological products, known as reference products, showing no clinically meaningful differences in terms of safety and effectiveness1. They are being manufactured by the big players in town, and are expected to be less expensive than their reference products. They will also be backed by powerful marketing teams, ample resources, and robust patient support service programs, thus making them even more of a threat to branded agents backed by the same support.
Biosimilars are entering into categories such as inflammatory diseases, diabetes and oncology, which are all areas associated with high treatment costs. Since payers are always looking for ways to control costs, we should certainly anticipate disruption of current market dynamics, once these agents are approved.
Biosimilars are also making a large splash with the government, our country’s largest payer. Some states (19 to date, to be exact), have already passed legislation allowing pharmacists to substitute a branded prescription for an available, approved biosimilar. The goal of this legislation has already been established as reduction in Medicaid spend. Comparable laws exist in most states, allowing pharmacists to substitute small molecule therapies with available, approved generics, but it seems the biosimilar law may pose additional risk. Due to the human-derived nature of biologics, it may not be able to be guaranteed that a biosimilar is the exact same molecule as its “similar” biologic… so who assumes this risk – the pharmacy? The manufacturer?
It will be very interesting to observe how the market reacts to biosimilars in general, but also more specifically, to the substitution laws. Will pharmacies be willing to take more clinical risk in switching out brands for biosimilars? Will the biosimilar manufacturers contract with payers for preferred biosimilar status? We don’t have answers to these questions just yet, but they are right around the corner.
Author: Jamie Van Iderstine
Sources: 1. US Food and Drug Administration. Biosimilars. http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/default.htm. Last updated August 27, 2015. Accessed October 9, 2015.