Will Biosimilars Meet the Market Similar Test?

Biosimilars face a dual challenge of competing with the original product’s clinical and marketing profile, i.e. are they both biosimilar and market similar. In this competitive environment, whatever approach biosimilar manufacturers select must demonstrate how their product adds value.

The approval last year in the EU of generic Remicade represents a milestone of sorts.  Biosimilars aim to replace, or at least compete with, products that generated over $100 billion in worldwide sales in 2013. While Europe has led the way in the development of a regulatory pathway for the approval of such products, the US is not far behind.

While clearly an attractive market, biosimilars face two significant challenges in their effort to replace their respective incumbent branded biologics. First, they must persuade clinicians and patients that the product is equally safe and efficacious. Second, and possibly more challenging, they have to be “market similar.”  That is, biosimilar manufacturers will need to offer the wrap-around market support programs that makers of branded biologics currently provide.

Existing capabilities for clearing the market similar bar will vary among biosimilar manufacturers depending on their experience with such wrap around initiatives.  Conversely, companies currently manufacturing biologics will have the opportunity to sustain their valuable franchises by strengthening and differentiating their support programs.

Clinically Similar

Even small molecule generics - where the active ingredient is identical to that in the original product - can have varying levels of efficacy due to the use of different fillers and coatings.  Depending on the disease area, this variation in efficacy can result in a safety risk, for example, in the treatment of cardiovascular conditions. Most physicians are aware of this risk, but balance it against the significant price reduction that small molecule generics are able to provide due to the low COGS, absence of clinical trial expense and limited marketing spend. 

For several reasons biosimilars will face a greater challenge convincing doctors to switch. As the manufacturing process dictates the composition of the product, these new market entrants can only be similar, not identical, to the original.  Safety concerns are more acute among physicians as they relate to biologics. Due to the mechanism of action and the fact that many of these drugs are infused or injected, when adverse events occur with biologics, they have had a tendency to be much more severe and harder to address. This will make doctors wary of permitting generic substitution. 

Having the data to prove that the biosimilar is as safe and efficacious as the original will be necessary to convince skeptical physicians and patients. These clinical trials will add a cost and resource burden to generic manufacturers that, combined with the higher cost of manufacturing, will limit their ability to offer biosimilars with discounts comparable to those for small molecule generics.

Market Similar

Both biosimilar and branded biologics manufacturers must decide the extent to which they need, respectively, to be market similar or reinforce their current support offerings. 

Depending on the market segment, based on geography or disease area, manufacturers have implemented various programs to support different stakeholders.  For example, patient education programs teach patients to use and store injectables; compliance programs help physicians maximize outcomes.  They also provide additional services supporting pharmacists and the supply chain.  Biosimilar manufacturers must decide the extent to which they need to be market similar in terms of the services offered and the approach to delivering them. 

What to offer

Clearly some elements of value-added services have become the cost of doing business.  If the product requires specialized supply chain handling such as refrigeration, these services must be provided.  Over and above these “table stakes”, what services are necessary and which are nice to have?  Companies must critically and objectively review the services currently provided, as well as those stakeholders might value but which aren’t currently available,  to determine what to offer.  This list of potential services might vary by geography, disease area, stakeholder and other variables.  The realm of what is possible is considerably larger than what is necessary or what might add value.  Prioritizing the options should be based on an analytical determination of the value they add to various stakeholders and to the manufacturer. 

Manufacturers may also want to consider the sequence and timing of offering various services.  While the need at launch is to be market similar in order to be competitive, novel or unproven concepts may benefit from a pilot or rolling launch approach to prove the concept before committing the investment required to broaden it to all market segments.

Manufacturers of branded biologics will find value in conducting a thorough review of their patient, physician, pharmacist and supply chain support programs to identify opportunities for implementing valuable, hard-to-replicate services.  The focus should be on offerings that enhance clinical outcomes and strengthen relationships with key stakeholders".

How to deliver these value-added services

Manufacturers of branded biologics will find value in conducting a thorough review of their patient, physician, pharmacist and supply chain support programs to identify opportunities for implementing valuable, hard-to-replicate services.  The focus should be on offerings that enhance clinical outcomes and strengthen relationships with key stakeholders.

Some companies who already produce, market, and sell biologics may have all the capabilities required to deliver the selected marketing activities.  Others may be able to extend their experience with small molecules into the biosimilar space.  Companies that don’t already have the capability to compete on the value-added service dimension will need to confront a complex build or buy decision. In that decision, an intimate understanding of the stakeholder value criteria and of competing offerings will be key factors.  They would benefit from seeking guidance about what stakeholders will value and about potential partners with capabilities to implement wrap around programs and experiment with various options to see what works best. 

Keys to Success

To commercialize biologics profitably, companies will need to supplement the requisite manufacturing capabilities with marketing expertise to ensure products that are both clinically and market similar at the time of launch.  Well in advance of commercialization, new market entrants will need rigorous analysis to understand market potential and identify those elements of the marketing mix that truly add value for various stakeholders. 

Price will not be a sufficient differentiator.  Existing manufacturers are not going to cede market share easily.  In fact, they will raise the bar on what it takes to be market similar, strengthening and enhancing their current programs.  In such a market-based competitive environment, new entrants will have to demonstrate how their product adds value through both its therapeutic and service characteristics.  

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