ror logoThe Affordable Care Act created new opportunities for many sectors of the health care industry, including biopharmaceutical companies. One ACA provision created the path for what is predicted to be a multi-billion dollar opportunity to shake up the biopharma industry and offer some of the most promising biologic treatments to more people at a lower cost. APCO Insight recently took a deep dive into biosimilar understanding and acceptance among industry stakeholders, including opinion leaders and health care professionals. Before sharing the APCO Insight findings, here is a quick explanation of biosimilars.

Biosimilars 101

Biosimilars are biologic medicines that are highly similar to already-approved biologic products and have no clinically meaningful differences in terms of safety, purity and potency.  People often assume biosimilars are “generics,” but there is a difference. My favorite explanation is one that I read by NPR’s Elana Gordon (and perhaps I can relate to it because of my love of both a great cocktail and a great glass of wine!).  A generic drug is like a cocktail:  you can take the ingredients and follow the right steps and proportions to create essentially the same thing.  But replicating a biologic is like trying to replicate your favorite Pinot Noir. You must account for the grapes, the fermentation and the aging process. Because biologics are grown from living organisms, it is impossible to develop an exact copy of the original drug.  And, for that matter, companies that make originator biologic are making copies that differ ever so slightly from their first batch.

Biosimilars are not new. They have an established presence in Europe – more than ten biosimilars have come on the market there since the first one was approved in 2006. So far, the FDA has approved two biosimilars in the US, and also recently issued its long-awaited Draft Guidelines for Biosimilars Labeling which recommends labeling for biosimilars use the clinical data gathered by the originator product the biosimilar is intended to emulate.

APCO Insight Findings

Findings from a 2015 survey conducted by APCO Insight among health care opinion leaders and health care providers help tell the story of the challenges involved in bringing an entirely new class of medical treatments to market.  

First, while the majority (60%) of key opinion leaders believe that biosimilars and biologics are similar to each other, which still leaves a third that are “neutral.” There is also a distinct difference in level of understanding between health care providers and opinion leaders - 36% HCPs say biosimilars are very similar compared to only 15% of opinion leaders.

There is also a lack of understanding about various properties of biosimilars, especially relating to ingredients and production method. Less than one-third confirm the difference between biosimilars and biologics completely matches their understanding of biosimilars, and even fewer indicate their understanding that biologics made by different manufacturers are different from each other (18% of HCPs and 17% of opinion leaders say it completely matches understanding).

% Completely matches understanding

HCPs

OLs

Unlike generic medicines where the active ingredients are identical, biosimilars are similar to but not identical copies of the originator biologic.

30%

24%

Biologics made by different manufacturers differ from the original product and from each other.

18%

17%

Due to the complex structure of biologic medicines and the processes involved in production, biosimilars are determined to be similar to an original biologic in terms of its structural characteristics, safety and efficacy profile.

23%

25%

Unweighted n-size

44

100

 

This gap in understanding biosimilars could potentially be filled by education efforts and ongoing dialogue. There is a real opportunity to drive the conversation surrounding biosimilars out of the “neutral” zone.

The lack of awareness of manufacturer differences in biologics also highlights a potential opportunity for established companies bringing new biosimilars to market. Given the perceived lack of difference between manufacturers, biosimilar consumers may support the products whose names they recognize. So as biosimilars enter the market and market share begins to fracture, it will be important for biopharama companies to be early to market and gain product name recognition. The field may get crowded quickly, so the biosimilars that cross the finish line early (with FDA approval) will have an advantage.

In bringing biosimilars to the US market, stakeholders have expectations for regulation but are still strongly supportive of bringing these products to market, despite low awareness. In terms of regulation, respondents indicate they support a number of parameters set in place for the use and distribution of biologics, including notifying patients if a biosimilar is substituted for a biologic (85% opinion leaders strongly or somewhat support, 82% HCPs), executing thorough clinical trial testing (83% opinion leaders, 80% HCPs), and establishing extensive post-market surveillance to ensure continued safety and efficacy (83% opinion leaders, 77% HCPs). Respondents also see the benefit of bringing biosimilars to the US – 61% healthcare providers and 71% opinion leaders strongly or somewhat agree that biosimilars can help reduce costs for both patients and the health care industry overall.

It’s an interesting time.  Clearly, as APCO Insight research confirms, there is a limited understanding of biosimilars. And that is likely the reason why, so far, the uptake in the US and around the world has been slow - despite biosimilars’ potential promise to expand patient access and reduce costs. For the companies that make biosimilars, now is the time to assert leadership through education and ongoing communication with all key stakeholders. 

For a visual guide to this topic, please find and feel free to share this infographic: 

Biosimilars: Opinion Leaders Want to Know More

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Iris Shaffer

Iris Shaffer, director in APCO Worldwide’s Chicago office, brings more than two decades of health care communications and media relations expertise. She has extensive experience working for both pharma and medical associations. Read More