Challenges for Launching Biosimilar Products


The ability of manufacturers to convey the efficacy and safety of a new biosimilar is crucial.

Launching any new pharmaceutical brand can be an extremely daunting task. There is an entire host of decisions that must be made, including distribution strategy, physician detailing, pricing, advertising, and regulatory concerns, among others.

With robust bipartisan support trying to regain control of rapidly increasing drug prices, it would be reasonable to assume that congress will take measures necessary to do just that. Congress may focus efforts toward clearing the FDA backlog.

This will lead to an increase in the rate of new product approvals and increase competition in the marketplace to drive down product costs. As a result, it is anticipated that a significant number of biosimilar products currently in the pipeline will be approved in the near future; however, a great deal of uncertainty exists surrounding biosimilar utilization, which adds complexities not seen with traditional products. Therefore, there are a number of questions manufacturers should consider as they prepare to successfully commercialize biosimilars.

First, how do manufacturers want their biosimilar to be perceived? Do they want to market the product as a generic of an already existing brand biologic or do they want the product marketed as a branded generic?

Manufacturers have the capability to do either and there could be fundamental changes to marketing strategy based on the approach employed. Brand name products have always commanded a price premium over their generic counterparts.

Therefore, biosimilar products marketed as brands reasonably stand to have a higher price point than a biosimilar marketed as a pure generic. Conversely, biosimilar products marketed as generics likely would have an opportunity to gather a greater market share and, consequently, potentially yield higher overall revenues. Manufacturers should employ extensive market research to determine which approach may be most beneficial for their product.

Secondly, manufacturers must consider what the anticipated physician response will be to their therapy. Influencers of physician acceptance may include the level of comfort with existing therapy options, ease of patient access to therapy, cost sensitivity, and the industry reputation of the biosimilar manufacturer.

Because the production of biologic medications takes a greater deal of expertise and specialized equipment than traditional generic medications, prescribers will have a higher level of comfort working with established and reputable manufacturers. Furthermore, as physicians continue to focus on value and quality, biosimilars that are able to significantly lower costs for health plans, pharmacy benefit managers, and patients will be welcomed.

Third, manufacturers should implement an appropriate direct to consumer advertising campaign and identify patient considerations that are key to their biosimilar product utilization. The advertising campaign should clearly convey that there is now a possible alternative to a more expensive branded biologic.

Historically, direct to consumer advertising has been very successful in driving utilization and there is little doubt that this would not hold true for biosimilars, as well. The ability of the manufacturer to convey the efficacy and safety of the newly available product and transitioning existing patients to a biosimilar product is crucial.

To remain competitive with the branded products, manufacturers offering biosimilars will need to ensure appropriate financial assistance programs are in place. Manufacturers have done a fantastic job offering co-pay and other assistance programs for commercial, Medicare, or other government funded individuals for high cost biologics.

These programs include the Patient Access Network, Healthwell, and the National Organization for Rare Diseases to name a few. In many cases, the out of pocket cost to patients is fully covered by these programs.

To be competitive, biosimilars will need to offer similar programs that cover all out-of-pocket expenses for patients. At the same time, biosimilar manufacturers will need to obtain preferential formulary positioning on the leading pharmacy benefit manager and health plan formularies.

While this may seem relatively easy to accomplish due to a lower published average wholesale price and wholesale acquisition cost for biosimilar products, branded manufacturers for a large majority of biologics are offering deep rebates on their products to payers. Successful negotiation with payers will be pivotal to product utilization.

Obviously, the degree of market competition within a therapeutic category or disease state will determine the degree of price concessions that a manufacturer will offer a payer. Manufacturers will be tasked with making key decisions to their channel strategy too.

Biosimilar products are expected to be less costly than their branded counterparts; however, they will likely still be priced high enough to be considered specialty medications. Moreover, most biologic medications are injectable, require special storage and handling, and have unique dosing and administration instructions associated with them.

All of these criteria are traditional hallmarks of specialty products. Therefore, it is reasonably expected that the majority of biosimilars will be dispensed by specialty pharmacies.

When selecting specialty pharmacies for distribution, manufacturers may select open, limited, or exclusive networks. One strategy for success may be to grant access for biosimilar products to pharmacies that currently dispense the branded medication.

This would serve 3 key purposes: First, pharmacists who have dispensed the branded medication possess the appropriate disease state and product training; second, there is a greater opportunity for patient conversion from branded product; third, pharmacies dispensing branded products have established relationships with high volume prescribing offices and may be best positioned to recommend conversion to the biosimilar.

With so many considerations beyond a traditional generic launch, manufacturers will need to perform comprehensive market research to best position their biosimilars for launch once approved.

Because the profile of almost all biosimilar products will meet widely accepted specialty product criteria, specialty pharmacies will serve as the key channel through which they are dispensed. Specialty pharmacies should prepare to accept and assist with the unique launch considerations of biosimilars.


S. Milmo, "Biosimilars: Making the Switch Comes with Challenges," BioPharm International 29 (6) 2016.

About the Author

Justin Smerker earned his PharmD degree in 2009 and his Masters of Science in Pharmacy Business Administration (MSPBA) degree, an executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines, in 2016 from the University of Pittsburgh. He is currently a National Account Manager for PANTHERx Specialty Pharmacy. In this role, Justin conducts RFP submissions, assesses channel strategy, participates in contract negotiations, evaluates the FDA pipeline, and prepares financial models for high cost specialty therapies. His experiences include leadership roles in account management for neurology and rare/orphan disease therapies. He is experienced in the implementation and delivery of high-touch patient care services as well as in clinical management, persistency, and adherence programs. Justin has also participated in the successful launch of newly FDA approved medications. Additionally, he has served as an adjunct clinical instructor for experiential education at Duquesne University. Prior to working in the specialty pharmacy sector, Justin successfully managed high volume retail pharmacies. To connect go to

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