Unlocking the Promise of Lower-Cost Biosimilars

At Pfizer, more than 90,000 colleagues come to work every day with a singular purpose: breakthroughs that change patients’ lives. Ingrained in our purpose is the realization that our breakthroughs won’t do anyone any good if patients can’t affordably access them. When I testified before the Senate Finance Committee in February, I proposed four ideas that Pfizer believes will drive meaningful savings for U.S. patients. Today, I’d like to expand on one of those ideas: advancing the uptake of lower-cost biosimilars.

Biosimilars are highly similar to FDA-approved branded biologics, with no clinically meaningful differences in terms of their safety and efficacy. They have been approved for a wide range of conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, plaque psoriasis, ulcerative colitis and several forms of cancer.

Biosimilars currently on the market have been estimated to cost, on average, nearly 30 percent less than their original branded products. That’s a real saving – one that could significantly lower healthcare costs for both patients and American taxpayers, while improving public health. In fact, the FDA estimates that last year Americans could have saved more than $4.5 billion with access to approved biosimilars.[i]

So, establishing a robust biosimilars market sounds like a no-brainer, right? Something we can all get behind? You would think so, but, unfortunately, too few patients have too little access to these lower-cost treatments.

As of April 2019, the FDA has approved 19 biosimilars to nine originator biologics.[ii] However, despite the demonstrated safety and efficacy profiles and significant potential cost savings of biosimilars, patients currently have access to only seven of the ones that have been approved.[iii] Why such a disparity? Because long-standing anti-competitive behaviors and marketplace dynamics have made it difficult for a biosimilars marketplace to flourish in the U.S.

With biosimilars to four of the top 10 biologic drugs (in terms of U.S. sales) included in our portfolio and pipeline,[iv] Pfizer is committed to helping as many patients access these important medicines as possible. That's why we are advocating for two solutions that we feel could have an immediate and meaningful impact on patients, providers and the overall healthcare system:

1. Reducing or eliminating patient out-of-pocket costs for biosimilars would increase affordability and access to these equally safe and effective therapies, leading to increased usage. Over the next decade, this could save up to $5.2 billion in taxpayer dollars[v] and reduce seniors’ out-of-pocket costs by as much as $3.3 billion.[vi]
2. Implementing a “shared savings” model whereby Medicare savings associated with prescribing a biosimilar, as compared with an originator biologic, would be shared with healthcare providers. This could save an estimated $3 billion in tax dollars over the next ten years.[vii]

At Pfizer, we support competition and believe these changes would help knock down barriers to lower-cost biosimilars, allowing them to have a similar impact as generics. Nine out of 10 drugs sold in the U.S. today are generics, which not only saves patients and the system [billions of dollars per year], but also helps increase patients’ adherence to their prescriptions[viii] – leading to improved outcomes. Pfizer sees a similar promise in biosimilars, and we will continue to work closely with policymakers and others in the healthcare system to unlock and enable this promise.

[i] FDA.gov. Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for delivery at the Brookings Institution on the release of the FDA’s Biosimilars Action Plan. July 2018.

[ii] FDA.gov. Biosimilar Product Information. April 2019.

[iii] Rothwell Figg IP Professionals (blog). FDA’s Biosimilar Approvals Accelerate in 2018: How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline. Table 2. February 2019.

[iv] Top 10 Biologic Drugs in the United States. The Balance. https://www.thebalance.com/top-biologic-drugs-2663233. Published February 4, 2019. Accessed April 2019.

[v] Biosimilars Forum. Structural Market Changes Needed in U.S. to Achieve Cost-Savings from Biosimilars. March 19, 2019.

[vi] www.supportbiosimilars.com/policies

[vii] www.supportbiosimilars.com/policies

[viii] Generic Drug Access & Savings in the U.S. 2017.