The coming wave of biosimilars: marketing to win

If you're planning to bring a biosimilar to market, you will have to stretch beyond conventional practices to be successful. However, the potential rewards are lucrative as you will be claiming a coveted share of the $169 billion biologic market¹, of which biosimilars are forecast to reach up to $35 billion by 2020².

It's a new frontier that requires a shift in both approach and mindset as the strategies that may have served companies well in the past with small-molecule generics will probably need repurposing to compete effectively.

"On one hand success depends on proving similarity; on the other you've got to differentiate to win"

It's 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 one hand success depends on proving similarity; on the other you've got to differentiate to win. This requires a stepped approach: first you have to fully establish similarity in the minds of physicians in order to gain receptiveness to discussions about differentiation.

As marketers we've been conditioned to quickly communicate 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.

Another hurdle to clear: establishing trust

Education is a big part of shoring up trust in biosimilars. Although awareness of, and familiarity with, biosimilars is increasing among doctors, there is still much education needed, particularly since these levels vary by speciality and by country. According to a survey conducted by the Alliance for Safe Biologic Medicines³, most physicians, while 'familiar' with biosimilars, have only a basic understanding of them. 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 to be tied to familiarity, is growing year-on-year according to one recent US and pan-European survey among Rheumatologists⁴, 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 different compared to those around a new Mechanism of Action molecule and market conditioning needs to reflect that. Creating a communications plan that effectively pre-empts concerns and instills confidence in what clinicians can expect of your biosimilar in clinical practice is essential and requires you to keep your finger on the pulse of shifts in awareness, perceptions and attitudes.

"Physicians are quicker to extend their trust to companies which have a long-established history in a particular category"

The good news is that physicians are quicker to extend their trust of a biosimilar to companies which have a long-established history in a particular category. So if you have 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.

One of biggest hurdles: 'If it's the same, why should I prescribe it?'

This is where you need to get creative. You're probably competing with an innovator biologic heavyweight that is not only tried and trusted, but already comes with a virtual treasure trove of value-added programmes and materials for patients. For example, AbbVie's Humira (adalimumab), Amgen's Enbrel (etanercept) and Sanofi's Lantus (insulin glargine) all invested heavily in relationship building in the medical community as well as development and deployment of patient support resources.

So, 'If it's the same, why should I prescribe it?' is a fair question. And, given that you're not likely to meet the 50-70 per cent reduced price expectation of a generic or a first- or second-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). This is where commercialisation planning and marketing get exciting.

"Biosimilar marketers and their agencies need to push well beyond competitive parity with the experience they deliver"

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:

1. 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; and

2. Partnering with innovators in the field of market research discovery to help re-frame how brand teams look at customer problems. Traditional research framing leads to predictable learnings, meaning brand teams fall back on marketing models not geared to 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 paths that lead to success for biosimilars in general, there are areas of exploration from which success is likely to rise.

For biosimilars, differentiation needs to mean a better experience

One prospect for differentiation is improvement to device delivery technology, which US FDA guidance on biosimilars clearly allows. Because biological molecule size usually requires delivery by 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 health-tech 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.

"It's not about abandoning the models that have led to success in the past; rather, it's about adjusting the formula"

For most biosimilar manufacturers, meeting ever-increasing value expectations will require new strategic planning models. In my experience, 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.

"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"

The expectation of customers today is that the value experience will be highly personalised. Often this involves bringing culture to the forefront in order to provide a different foundation to understand beliefs and behaviours and influence them. In taking a more holistic approach, marketers can 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 from big pharma to major generics companies⁵. And with some innovator biologics having up to 20 or more biosimilars in development⁶, there's no doubt competition will be intense. Beyond navigating the legal and regulatory uncertainties, which is no small feat, winning will require significant resources 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 [White Paper]. Retrieved from here.

² Allied Market Research. (2014). Biosimilars/Follow-on-Biologics Market is Expected to Reach $35 Billion, Globally, by 2020 [Press Release]. Retrieved from here.

³ Generics and Biosimilars Initiative Journal (2014). 3;3(2):58-62. Retrieved from here.

⁴ Research Partnership. (2014). Biosimilars: Friend or Foe to Healthcare? [Webcast]. Retrieved from here.

⁵ Thomson Reuters. (2014). Biosimilars Set to Revolutionize Global Drug Development Industry with More Than 700 Therapies in Pipelines [Press Release]. Retrieved from here.

⁶ FirstWord. (2013). Which biologics face the most competition from biosimilars? Retrieved from here.

About the author:

Donna Vetter operates a research-driven consultancy firm specialising in marketing and communications planning for the life sciences sector. She offers a wide range of services honed by decades of US and international experience. Contact her at: DVetter@att.net or +1-480-225-2214; LinkedIn http://tinyurl.com/DonnaVetter, or Twitter @Donna_Vetter

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