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Manufacture Biosimilars, Standards & Regulation

Towards Better Biosimilar Access

In theory, biosimilars should level the playing field when it comes to medicine access. These drugs are designed to replicate biologics but without the high price tags. But does the reality match the vision? Steven Selde, Director of the Biosimilars Council, Association for Accessible Medicines, outlines why biosimilars may not reach patients in need and lays out the steps the industry will have to take to ensure equitable access.

What’s going right with biosimilars in terms of access to medicines – and what’s going wrong?
 

Biosimilars represent new access to care for patients. Even in the face of adoption challenges, biosimilars have provided new access to more than 10 million days of therapy. This feat would not have been possible without them.

But too many patients still lack access to biosimilars as a result of pharmacy benefit managers' (PBM) formulary decisions in favor of higher-cost brand drugs with high rebates. The Health and Human Services Office of Inspector General highlighted this challenge in Medicare Part D, noting that many formularies did not include biosimilars, and those that did often failed to encourage biosimilar adoption.

How can companies ensure biosimilars are fairly priced?
 

Biosimilars are bringing important and meaningful price competition to the market. We’ve seen price decreases across the board once biosimilar competition begins. Every market is different but, according to Medicare data, the average biosimilar price is almost half what the reference biologic’s price was at the time of biosimilar launch. Additionally, the brand price is more than a quarter lower than when it was first subject to biosimilar competition. If policymakers ensure coverage and reimbursement policies are aligned to support greater adoption of these lower price options, this robust price competition will continue.

What are the biggest challenges biosimilars face in coming to market, particularly in the US?
 

It was only in 2010 that Congress authorized the US FDA to create a pathway to review and approve biosimilars, making this a fairly new product with evolving market dynamics. To date, biosimilar development and marketing have faced two main challenges.

The first challenge is education. Biosimilars have faced significant brand-initiated misinformation and disparagement campaigns that sow doubts in patients’ and providers’ minds. To aid patients and healthcare professionals, the Biosimilars Council has developed a variety of educational resources. The FDA also has a host of resources, and most recently published medical degree curriculum materials to help educate students in medical, nursing, physician assistant, and pharmacy programs, as well as practicing healthcare professionals. The work that the agency and some health care professional groups have done to educate providers and patients on biosimilars is crucial and must be continued.

Second, as previously mentioned, biosimilars have been hindered by drug reimbursement and formulary design policies. For example, an IQVIA study highlighted that biosimilar adoption was greater when the relative reimbursement was higher for the biosimilar. The study also observed that providers in the oncology care model, which holds providers accountable for the total cost of care, used biosimilars more often than other providers. PBM formulary design is too often swayed in favor of high-cost, high rebate brand drugs.

Congress can address these challenges through some straightforward bipartisan proposals. In Medicare Part B, Congress can increase the add-on payment for providers when they use a biosimilar or direct Centers for Medicare & Medicaid Services to create a shared savings demonstration program. Under these programs, providers would choose the right medicine for their patient but receive higher reimbursement when they use the lower-cost option. 

Congress can also update the Medicare Part D program to better encourage health plans that prioritize lower-cost medicines such as biosimilars. Not only would these proposals mean lower costs for taxpayers, but they would also mean lower out-of-pocket costs for patients. Addressing these respective challenges would result in billions of dollars in savings for all. 

Are you optimistic about the future?
 

Yes, biosimilars have clearly established their value proposition, and we will see this grow in future years. For instance, beginning next year, it is likely that patients will have access to more than seven biosimilar versions of the best-selling drug Humira. IQVIA projects that biosimilars will generate more than US$130 billion in savings by 2025. But I believe there are greater savings to be realized if policymakers take action on these issues.

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About the Author
Maryam Mahdi

Deputy Editor

After finishing my degree, I envisioned a career in science communications. However, life took an unexpected turn and I ended up teaching abroad. Though the experience was amazing and I learned a great deal from it, I jumped at the opportunity to work for Texere. I'm excited to see where this new journey takes me!

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