The Challenges of Commercializing Biosimilars
Deirdre Coleman talks to Darwin Cox, Strategy and Commercial Innovation Director, Merck about the complexities of biosimilar commercialization and the value-added services strategy that will ensure commercial success.
Analysts agree that biosimilar market size is set to explode in the next few years, ranging between $2-3 billion by 2015, according to IMS research. Forces driving the rapid expansion of the biosimilars industry are an ever-increasing pressure to reduce healthcare costs, expectations for booming market growth due to patent expiry of high-value innovator biologics and better-defined regulatory pathways. However, lower price is not enough to guarantee commercial success and maximize uptake; biosimilar companies must ensure the physicians and patients are comfortable with the comparative efficacy and safety of its biosimilar products while optimizing access among payers.
According to Darwin Cox, Strategy and Commercial Innovation Director, Merck: “For new entrants, biosimilars pose very different challenges to those presented by small molecule generics, with more demanding requirements in terms of clinical development, market access, manufacturing and sales and marketing capabilities. Unlike novels where the product is the focus of differentiation and you are striving for best-in-class status, with biosimilars, the product is similar to the originator so the services surrounding that product become a means of differentiation and are the key to becoming the preferred choice against competitors.”
Unlocking the potential of biosimilars will require a focused strategy along the whole value chain, from optimizing the clinical development program through developing the most suitable strategy for commercialization. An effective market access strategy will be a vital lynchpin for successful entry: the value proposition is complex and will need to address the full range of stakeholder requirements.
Creating Value-Added Services
The biosimilars market is complex with many factors that may impact market potential including:
- Physician/Patient Adoption
- Price differential from originating biopharmaceutical
- Development Cost
- Indication (chronic v acute)
- Sales & Marketing Experience
Success in overcoming these barriers and obstacles will necessitate a unique go-to-market strategy that encompasses the needs of the multiple stakeholders, enabling them to be comfortable switching from an originator to a biosimilar.
“Cost is only one of many considerations in the biologics market. Stakeholders have needs and requirements that are multifaceted and these vary across markets and cultures.”
“There are basic requirements that need to be met: assurance of safety and efficacy and assurance of manufacturing capability (no shortages or quality issues). Due to their complexity, biologics require a wide array of support and services.”
“For patients, many need to learn how to correctly inject themselves, others need to allocate enough time for IV infusions to better manage their chronic condition. A patient’s state of mind and associated behavior should also be considered. These all require adequate training and support. For physicians, they need to know they have made the right choice for the right patient. They need to dedicate enough space for cold storage to ensure product freshness. They are also concerned about the financial and operational management of their practice. Since biologics are priced significantly higher than small molecules, these often involve more complex payment processes to control costs. Unfortunately, this can reduce access to patients and create an additional burden on pharmacists, physicians, and payers. For each of these stakeholders, anything that can be done to make their life easier will be appreciated. ” concludes Cox.
The biosimilars market is currently in its infancy and it remains to be seen whether they offer a real threat to their branded innovator counterparts. The commercialization strategies for biosimilar manufacturers will probably develop as a hybrid of generic and originator approaches. In the early years, companies will use commercialization tactics reminiscent of those for originator products including medical communication activities, clinical detailing to prescribers and product branding. These tactics will move eventually towards a more generic approach based on lowering the cost of sales as acceptance of quality, safety and efficacy increases.
Darwin Cox will be speaking on “Looking Beyond the Pill” at eyeforpharma Philadelphia 2014
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