Addressing Patent Hurdles, Payer Barriers, and Interchangeability

Global Biosimilars Week discussed issues in biosimilar adoption and called for reforms to streamline processes, foster competition, and increase biosimilar access for patients. | Image Credit: Supatman - stock.adobe.com

Global Biosimilars Week, a worldwide online biosimilar advocacy event hosted by the International Generics and Biosimilars Association, took place between November 11 to November 15.¹ The event focused on challenges that exist among the patent system, payers and pharmacy benefit managers (PBMs), and interchangeability designation while solutions were proposed to improve biosimilar adoption.

The Patent System

The Biologics Price Competition and Innovation Act (BPCIA) includes a structured legal process referred to as “the patent dance” that was designed with the intention to assist with streamlining patent disputes between biosimilar manufacturers and reference product sponsors. The overall goal of the patent dance is to increase biosimilar entry into the market while the interest of innovators who initially developed biologic therapies remains balanced.

The patent dance has proved to be effective when fostering negotiations and settlements while avoiding potentially costly legal fees. However, some criticism from industry stakeholders has suggested to further streamline the BPCIA framework to make the process less intense and more predictable for developers.

Though the patent dance remains complex, it is considered one of the main drivers of efficient biosimilar development in the US, fostering a competitive landscape that promises greater access to these critical medications for various patient populations.

Underlying issues within the US patent system allow drug companies to obtain market exclusivity on products, manufacturing processes, device design, development process, and other processes. This has often led to a blockade of patents that biosimilar and generic manufacturers find it difficult to push through. These challenges can lead to launch delays which then result in product hopping, when drug companies shift their demands from innovator drugs to new, patented versions.

The adalimumab biosimilar market is competitive right now, with many products launching within a short timeframe. While biosimilar adoption is rising, AbbVie's patient conversions and launch delays hinder their sustainability.

To address these issues, Congress called on the Federal Trade Commission to address product hopping and antitrust concerns. Policy makers should consider the impact of patent reforms on the entire system.

Payer and PBM Policies

Biosimilar access is heavily impacted by PBMs and payers who determine levels of coverage and if they will be preferred over their originators.² Payers and PBMs have previously prevented biosimilar adoption over the prioritization of other drugs based on reimbursement strategies instead of medical need.

PBMs select biosimilars for rebates and reimbursement, aligning with payer policies and formularies. While rebates are intended to reduce drug costs, they're often higher for reference drugs than biosimilars. This leads to higher out-of-pocket costs for patients, despite potential savings.

Reimbursement negotiations between PBMs and payers can subtly influence prescribing practices, often without patient transparency. Payer policies may not inform physicians of coverage changes for reference products or specific biosimilars, leading to unexpected treatment switches. Medicare beneficiaries face fluctuating cost sharing throughout the year as out-of-pocket spending thresholds are reached as well.

Some companies have adjusted their pricing strategies to align with PBM and payer preferences, particularly in the insulin and adalimumab markets. This involves launching both branded and unbranded products at 2 price points. This dual-pricing approach offers lower-cost options for patients while incentivizing PBMs to include higher-cost products on their reimbursement lists. However, health care providers have expressed concerns about PBMs and payers interfering in the doctor-patient relationship and treatment decisions.

Panelists at the GRx+Biosims conference advocated for greater PBM transparency and policy changes to promote fair competition, wider biosimilar access, and lower costs. They suggested reforms to specialty pharmacy dispensing fees in retail settings to encourage biosimilar adoption across various channels. Additionally, they proposed Medicare reimbursement adjustments and payer formulary revisions, such as step-therapy or reduced co-pays, to prioritize biosimilars.

Interchangeability

The FDA published updated draft guidance titled “Consideration for Demonstrating Interchangeability with a Reference Product: Update” to further describe the switching study requirements that intend to support biological products as interchangeable with the reference product.³

When the FDA rules a biosimilar product as an interchangeable biologic, the biosimilar product may be substituted for the reference product by a pharmacist other than the health care provider who wrote the original prescription. Interchangeability designations are only relevant to dispensing, not prescribing.

Dracey Poore, MS, director of biosimilars at Cardinal Health Emerging Therapies, highlights the importance in acknowledging interchangeability designation as a regulatory decision rather than a clinical designation. The guidelines expect each biosimilar to prove it is similar to the reference biologic with no clinically meaningful differences in safety, purity, and potency.

Interchangeability studies are often expensive for pharmaceutical manufacturers, ranging from $100 million to $300 million. The average timeline to develop a biosimilar can take between 6 to 9 years across the entire process. The new guidance aims to reduce the costs and time necessary to bring biosimilars to market while helping promote sustainability.

Addressing these issues through policy reforms and industry collaboration is crucial to fully realize the benefits of biosimilars and ensure a sustainable health care system.

References

1. Jeremias S. Breaking down the biosimilar barriers: the patent system. Center for Biosimilars^®. November 11, 2024. Accessed November 21, 2024. https://www.centerforbiosimilars.com/view/breaking-down-biosimilar-barriers-the-patent-system

2. Jeremias S. Breaking down barriers: payer and PBM policies. Center for Biosimilars. November 13, 2024. Accessed November 21, 2024. https://www.centerforbiosimilars.com/view/breaking-down-biosimilar-barriers-payer-and-pbm-policies

3. Poore D. Breaking down biosimilar barriers: interchangeability. Center for Biosimilars. November 14, 2024. Accessed November 21, 2024. https://www.centerforbiosimilars.com/view/breaking-down-biosimilar-barriers-interchangeability