Biosimilars: Finding the Right Path to Differentiation

Biosimilars are coming. How will biosimilar value-added marketing measure up to the innovator behemoths? Value needs to extend far beyond modest price reduction and will be measured by a unique set of expectations coming to the US.

If you're planning to bring one to market, claiming a coveted share of the $169 billion biologic market¹-of which biosimilars are forecasted to reach up to $35 billion by 2020²-will mean stretching beyond conventional practices. It's a new frontier that requires a shift in both approach and mindset. For those planning to market a biosimilar, the types of strategies that may have served companies well in the past with small-molecule generics will likely need retooling to effectively compete.

A challenge at odds with itself

Marketing a biosimilar brings a unique set of challenges, the most fundamental of which feels like a contradiction: On the one hand success depends on proving similarity; on the other you've got to differentiate to win. This requires a stepwise approach-first you have to fully establish similarity in the minds of physicians in order to gain receptivity to discussions about differentiation.

As marketers, we've been conditioned to quickly get across our point of differentiation. But doing so too fast with a biosimilar can lead to tune-out if you haven't passed the first hurdle on similarity.

Establishing trust

Education is a big part of shoring up trust in biosimilars. Although awareness and familiarity with biosimilars among physicians are increasing, there is still much work to be done on the education front-particularly since these levels vary quite a bit by specialty and by country. According to a survey conducted by the Alliance for Safe Biologic Medicines, most physicians, while "familiar" with biosimilars, have only a basic understanding of them and many can't tell you what one is. That signals a lot of market conditioning to be done as the patent cliff for major biologics looms.

And while willingness to consider prescribing a biosimilar-which is likely tied to familiarity-is growing year over year, according to a recent US and pan-European survey among rheumatologists,³ the reasons cited for not considering them include barriers that can be overcome through fundamental education: doubts about purity, questions relating to clinically meaningful differences in efficacy, immunogenicity, and other safety concerns.

These underlying reasons for doubt and concern are very much different versus a new molecule or mechanism of action, and market conditioning needs to reflect that. Creating a communications plan that effectively preempts concerns and instills confidence in what clinicians can expect of your biosimilar in clinical practice is essential. It requires that you keep your finger on the pulse of shifts in awareness, perceptions, and attitudes on a near-constant basis.

The good news is that physicians are quicker to extend their trust about a biosimilar to companies that have a long-established history in a particular category. So if you've got an established heritage, be sure to leverage it. If not, be prepared to invest more heavily, as it may require greater effort and resources to secure trust.

'If it's the same, why should I prescribe it?'

This is where companies need to get creative and really stretch. Most likely you're going up against an innovator biologic heavyweight that's not only tried and trusted, it already comes with a virtual treasure trove of value-added programs and materials for patients. Take, for example, AbbVie's Humira (adalimumab), Amgen's Enbrel (etanercept), and Sanofi's Lantus (insulin glargine). These companies have all invested heavily in relationship-building in the medical community as well as development and deployment of patient support resources.

Hence, "If it's the same, why should I prescribe it?" is a fair question. And, given that you're not likely to meet the 50% to 70% reduced-price expectation of a generic or a 1st or 2nd-tier formulary status in the US that comes with little or no patient co-pay, you've got to offer a differentiated value proposition (and don't expect physicians, payers, or consumers to go easy on you with something soft). This is where commercialization planning and marketing get exciting.

Unless your financial targets are set at a commodity level, delivering marginal benefits won't be enough. Biosimilar marketers and their agencies will need to push well beyond competitive parity with the experience they deliver. Value expectations are high in biosimilar categories and higher still where entrants may include biobetters. The value delivered needs to be genuinely transformative-helping healthcare providers to deliver better care that improves outcomes and/or significantly increases patient satisfaction.

Finding a different approach to differentiation

Embracing the catalysts that can lead to transformational differentiation is an important first step for biosimilar brands. Consider, for example:

» Expanding the inner circle of idea generators to include thinkers who can offer forward-looking perspectives on the emerging and near-future world of health management. This includes health-tech thought leaders and, in some cases, healthcare futurists-both of whom can more quickly see opportunities for truly differentiated value solutions.

» Partnering with innovators in the field of market research discovery to help reframe how brand teams look at customer problems. Traditional research framing leads to predictable learnings, which, in turn, puts brand teams on a path to fall back on marketing models not geared toward the complexities and demands of biosimilar markets. We've got to learn to do things differently starting upstream in the strategic planning process.

While there aren't clear-cut paths that lead to success for biosimilars in general, there are areas of exploration from which success is likely to rise.

Differentiation needs to play out on a better experience

One prospect for differentiation is improvement to device delivery technology, which FDA guidance on biosimilars clearly allows for. Because biological molecule size usually requires that it be delivered via injection, opportunity exists to improve upon the innovator product's delivery device without affecting the safety and efficacy. Since the device is often a major component of the daily patient experience-particularly for chronic conditions such as diabetes and rheumatoid arthritis-this can represent a compelling point of differentiation for your biosimilar brand.

Technology-based experiential differentiation can, of course, be extended to support services, too. The near-daily advances in the health-tech space offer a vast range of possibilities that can serve personal health management needs from next-generation wearable gear to "smart" at-home health monitors. Partnership with the health-tech community is just another option to deliver a differentiated value experience.

For most biosimilar manufacturers, meeting the ever-increasing value expectations will require new strategic planning models. It's not about abandoning the models that have led to success in the past; rather it's about adjusting the formula to identify ways in which differentiated value can be delivered. From the marketing research perspective, this means not only assessing customer wants and needs very differently, but also from new vantage points. For example, taking a more holistic view of the end customer-zooming out to look beyond the patient-only aspect of their experience.

The expectation of customers today is that the value experience will be highly personalized. Often this involves bringing culture to the forefront in order to provide a very different foundational context both to understand patient beliefs and behaviors and influence them. In taking a more holistic approach, marketers are able to deliver differentiated value solutions that help patients fit the condition into their lives, not their lives into the condition. This is where the bar is set and, for many conditions where biosimilars are in development, there is tremendous opportunity to deliver on this expectation.

Winning will take fortitude-and more

Reportedly, there are currently more than 700 biosimilars in development by a diverse range of companies spanning big pharma to major generics companies. And with some innovator biologics having up to 20 or more biosimilars in development, there's no doubt competition will be intense. Beyond navigating the legal and regulatory uncertainties, which is no small feat, winning will require significant resource investment as well as a strong commitment to differentiate in new, innovative ways.

References

1. IMS Health. (2013). Searching for Terra Firma in the Biosimilars and Non-Original Biologics Market.

2. Allied Market Research. (2014). Biosimilars/Follow-on-Biologics Market is Expected to Reach $35 Billion, Globally, by 2020.

3. Research Partnership. (2014). Biosimilars: Friend or Foe to Healthcare? (Webcast).

Donna Vetter is President of Vetter Consulting LLC. She can be reached at DVetter@att.net.