Biosimilars in the US: Five Key Commercial Considerations

The landmark approval by the FDA earlier this month of Novartis’ Zarxio means biosimilars have finally arrived on U.S. shores. The long-awaited approval of the injectable drug that mimics Amgen’s biologic Neupogen, is welcome news for at least 150 manufacturers already investing in biosimilar development, manufacturing and commercialization. Estimates suggest a global market for biosimilars of $20 billion by 2020, and this first approval in the United States marks a major milestone on the path to achieving that goal.

Companies entering this blossoming market should now be turning even greater attention to commercialization. To assure that they maximize the commercial opportunity ahead, companies must consider five critical factors: country, category, company, competition and customer.  

Failing to consider each carefully will undermine not only revenue, but also success in getting the new medicines to patients in need of affordable treatment.

Country: Country considerations include levels of intellectual property protection, regulatory pathways and policies on interchangeability and automatic substitution. France, for example, last year became the first country to empower pharmacists to substitute a biosimilar for a “reference biologic.” Here in the United States, legislation regarding biosimilars varies from state to state and is constantly evolving. As of last December, eight states (Oregon, North Dakota, Utah, Indiana, Florida, Virginia, Delaware and Massachusetts) had enacted statutes that permit pharmacists to dispense a biosimilar in place of a prescribed biological product. Fourteen states had similar bills filed that did not pass, and in New Jersey, a bill is under consideration. The trend is toward opening markets to biosimilars but companies must keep a close eye on the ever-changing, state-level landscape to assure the trend continues.

Category: As a relatively new and evolving category, biosimilars have a unique opportunity in these early days to educate payers, physicians, policymakers and patients to allay fears and set expectations on value. The Medical Affairs organization and medical science liaisons (MSLs) have an important role to play in raising market awareness. And, the biosimilars story being told must be about more than lower cost, it must also stress outcomes. Relationships must be built to assure effective monitoring of adverse events and to provide the support that prescribers and patients will need in adopting this new category of products. All of this contributes to the long-term building of trust.

Company: Like anyone else, physicians, patients and payers want to feel trust in both the product and the company making the product. The reputation of a company manufacturing biosimilars is even more important than a company manufacturing typical products because the category of product is relatively new. C-suite executives have a critical role in establishing the credibility and commitment of their companies. Larger and older companies with established corporate equity are ahead of the game. In a recent survey, one U.S. oncologist summed up the particular challenge facing mid-size and smaller companies: “It would give me peace of mind if the product is coming from a big player.” Innovator companies will need to build trust through strategic, carefully crafted communications that are credible, accessible and backed by data.  

Competition: Competition for biosimilar makers is not limited just to the originator products. Manufacturers must be keenly attuned to the development of second-generation biologics, built upon the demonstrated track record of an available molecule, but even safer and more effective.  Manufacturers of second-generation products able to shift the standard of care paradigm and convert patients to an improved molecule could reduce market demand for biosimilars that mimic the original products. On the other hand, failure to convert patients from an originator to a second-generation product could create expanded opportunities for cost-effective biosimilars.

Meanwhile, biosimilar makers face familiar competition from other biosimilars targeting the same pathways. Novartis’ newly approved Zarxio, for example, may soon face competition from another copycat Neupogen already under FDA review.  

Customer: The customer landscape is a complex mosaic of physicians, payers, regulators and patient advocacy groups all of whom have questions about the quality and reliability of biosimilars. To overcome stakeholder skepticism and build support for a product, companies must educate opinion leaders to reduce confusion around product nomenclature, and provide medical education on product attributes and how they compare to the reference drug. Appealing to payers is the first, major hurdle. Without assurance of reimbursement, physicians will be reluctant to prescribe.

As for payers, they acknowledge that biosimilars are comparable to their biologic counterparts but do not necessarily consider them equivalent. They want to see a biosimilar product’s clinical, comparative and market data. All this data must be gathered earlier in the clinical trial process. And in making a case to payers, manufacturers should remember that they have acknowledged that a biosimilar could be chemically different but functionally the same as a biologic, leading to many unknowns that must be considered around the notion of “tolerable variance.”

Physicians are a critical part of the conversation and must be comfortable. A physician’s decision to discuss biosimilar options with patients will vary by therapeutic area, specialty and patient dynamic. Physicians also may prefer prescribing a biosimilar for a new patient rather than switching patients from reference drugs to biosimilars. To engage physicians, manufacturers must make sure prescribers truly understand both a biosimilar’s clinical and economic benefits.

Patients must be educated too so that they’re willing to switch to a newer product that may not offer the same level of patient support, such as patient assistance programs for specialized products. At the same time, in the new American healthcare marketplace, most patients will value products that offer efficacy similar to their current treatment, but at a lower out-of-pocket cost.

All these challenges will be addressed over time, and the most successful biosimilar companies will benefit both from overall pharmaceutical industry growth and a new market with enormous global promise.

Rohit Sood is Head of Global Launch Excellence at Campbell Alliance, an inVentiv Health company.  He can be reached at Rohit at Rohit.sood@inventivhealth.com