Biosimilars, which at the most simplistic level can be thought of as a type of generic option for a biologic, offer an opportunity to help reduce total biologic drug spend.
The United States is the world’s most expensive market for biologic drugs, with sales estimated at $125 billion in 2018.1 Additionally, despite less than 2% of the US population using these products, they account for 26% of the national prescription drug spend.2
Biosimilars, which at the most simplistic level can be thought of as a type of generic option for a biologic, offer an opportunity to help reduce total biologic drug spend. It’s been estimated that biosimilars could save patients and the health care system from $54 to $250 billion over their first 10 years on the market.2
Unlike true generic drugs, biosimilars are generally large and complex molecules produced from living organisms. To be approved by the FDA, the agency requires analytical studies, animal studies, and a clinical study in 1 or more of the indications for which the reference product is licensed.3
The approval of the Biologics Price Competition and Innovation Act (BPCI Act) in 2009 laid the groundwork for biosimilar approval in the United States. The purpose of the pathway was to provide more treatment options, increase medication access, and lower health care costs. Despite this, the United States has lagged behind other parts of the world in terms of biosimilar pathway and approval. For example, the European Union has more than 50 biosimilars on the market, which has helped increased competition and driven prices down.
As of December 2019, there have been 27 biosimilars approved by the FDA, with only 12 currently on the market.
Possible Launch Date
Q2 2020 or 2029 (pending court decision)
No plans to launch in US
Retacrit (epoetin alfa-epbx)
Q2 2020 or 2029 (pending court decision)
Enhertu (fam-trastuzumab deruxtecan-nxki)
However, the biosimilar pipeline is robust, and continues to grow. According to a recent estimate, there are more than 1000 biosimilars in any stage of the pipeline, representing an annual growth of 21% from 2016.4
Challenges to Widespread Adoption
Reasons for the United States’ slow adoption of biosimilars are multifactorial, but generally fall into several buckets.
Many biosimilars that have been approved by the FDA have not launched to the market. The primary reason for this revolves around patent litigations. Although the 2009 BPCI Act grants biologic drug manufacturers a 12-year market exclusivity period, which is longer than anywhere else in the world, patent abuses further delay competition.1
Unlike generic drugs, which average less than 80% of the cost of the reference product, the difference between biosimilar and originator product are much less, often approaching a 10% to 15% difference. This can be attributed to the high financial cost of entry for biosimilars. For example, development costs for generic drugs typically range from $5 to $10 million, whereas the average estimated development cost of biosimilars is between $100 and $300 million per product.1 Furthermore, it’s not uncommon when biosimilars enter the market for the originator manufacturer to offer payers and providers rebates to further offset any price difference.
According to several surveys, physicians cite confidence as a major barrier to biosimilar adoption. In 1 survey, only 45% of physicians believed that biosimilars would be safe and appropriate for use in both treatment-naïve and existing patients, whereas more than one-third believed that a biosimilar would be less safe than the reference biologic.5 In another survey, approximately half of physicians expressed a “complete understanding” of biosimilars, and 74% indicated that physician confidence is the main barrier to widespread adoption.6
Other barriers for biosimilar adoption include a lack of public awareness, payer formulary preferences or reimbursement, issues around product interchangeability, and extrapolating indications.
Although the biosimilar market has been much slower than many had expected when the BPCI Act went into law a decade ago, there is reason to be hopeful for the future. As more products get introduced to the market and physicians become more comfortable with these products, it is not unreasonable to expect to see much larger uptake in the coming years.