Biosimilar Policy Roundup—September 2024

In September 2024, the FDA approved a new biosimilar for treating retinal conditions, marking a significant development in the biosimilars landscape, coinciding with ongoing legal disputes in the industry and highlighting broader trends in market dynamics and regulatory challenges.

New Policy Updates and Considerations for the Future

The FDA has approved Pavblu (aflibercept-ayyh), the fifth biosimilar to Eylea (aflibercept), for treating retinal conditions such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. Developed by Amgen, Pavblu's approval follows a series of approvals for other aflibercept biosimilars in 2024.

The approval was based on a phase 3 study comparing Pavblu to Eylea in 576 patients. Results showed no significant differences in efficacy or safety, confirming Pavblu's biosimilarity to the reference product. However, Amgen and Regeneron, Eylea's manufacturer, are currently involved in legal disputes regarding patent infringement related to Pavblu's development. A hearing to determine if Amgen can launch Pavblu amid this legal challenge took place in August 2024, with the court's decision pending.

By the end of 2023, generics and biosimilars generated $445 billion in savings in the US, totaling $3.1 trillion over the past decade, according to a report from the Association for Accessible Medicines. The report highlighted the effectiveness of policies promoting these products. In 2023 alone, generics and biosimilars accounted for 90% of all prescriptions while making up only 13% of drug spending and just 1% of total health care expenditures.

The report revealed that generic drugs saved Medicare $137 billion and the commercial market $206 billion in 2023. Biosimilars contributed $12.4 billion to this total, with patients benefiting from significant therapy days due to increased competition.

In a recent Q&A, Sophia Humphreys, PharmD, MHA, BCBBS, director of system formulary management at Sutter Health, discussed the challenges and strategies for expanding biosimilars into new therapeutic areas at an event hosted by The American Journal of Managed Care^®. She highlighted the need for education about biosimilars’ safety and efficacy, particularly as adoption in areas like immunology and ophthalmology has been slower than in oncology.

Key factors for competition among adalimumab biosimilars include patient preferences for formulations and interchangeability regulations. Pricing strategies have varied, with some success in driving down reference product prices through competition.

Humphreys views the adalimumab market as a learning opportunity and emphasizes the importance of integrated delivery networks closely monitoring FDA approvals, collaborating with payers, and integrating biosimilar tools into electronic health records to enhance adoption and maximize cost savings for patients.

A study published in the Journal of Law and the Biosciences highlighted both the potential and challenges of developing biosimilars for gene therapies. While biosimilar competition could have lowered prices and enhanced patient access, obstacles such as regulatory complexities, manufacturing difficulties, and intellectual property issues hindered their market entry.

As of August 2024, the FDA had approved 38 cell and gene therapies (CGTs), which revolutionized treatment but came with high costs that strained health care budgets. The study, informed by interviews with 21 experts across various sectors, emphasized the need for clearer FDA guidelines and better regulatory frameworks for CGTs and their biosimilars.

Experts noted challenges in defining biosimilarity, particularly for cell therapies, which involved complex processes and proprietary protections. The evolving landscape required adapting existing biosimilar pathways to meet the unique needs of CGTs. Additionally, pricing dynamics, especially within Medicare and Medicaid, complicated the market for CGT biosimilars, but potential solutions like outcomes-based contracts could have helped manage costs and improve access.

How Current Policies Are Measuring Up

A recent white paper from Centara highlighted that oncology and supportive care biosimilars secured significant market share in the US, saving the health care system millions. The Inflation Reduction Act (IRA) provided a modest boost to biosimilar utilization through enhanced Medicare reimbursement, although its overall impact was limited by market competition.

The survey involved 79 facilities administering intravenous oncology therapies and found that while awareness of the IRA's policies was moderate—particularly among larger facilities—91% of respondents used at least 1 biosimilar, with trastuzumab biosimilars showing the highest adoption rates.

Key provisions of the IRA included increasing Medicare rebates for biosimilars and instituting a cap on patient out-of-pocket costs for insulin. However, only biosimilars priced below their reference products qualified for enhanced reimbursement, complicating the landscape for newer market entrants.

While the IRA reportedly led to a slight increase in biosimilar utilization, many facilities cited reasons for not adopting more biosimilars, including lack of awareness and existing contracts with originators. Despite this, nearly 90% of respondents anticipated increased biosimilar use in the next 5 years, driven in part by IRA policies. Overall, while the IRA had some positive effects, the report suggested a limited impact thus far, with optimism for greater effects in the coming years, particularly in the bone health and ophthalmology sectors.

A recent study in Health Affairs Scholar revealed that while biosimilar competition has significantly lowered prices, originator products with sole preferred coverage strategies retained their market share, indicating that biosimilar uptake alone may not fully capture the market's competitive dynamics.

Key findings included a decline in payer preference for originators like Remicade (infliximab) and Neulasta (pegfilgrastim) after biosimilars were introduced, though these originators remained more preferred overall. Conversely, Herceptin (reference trastuzumab) and Neupogen (reference filgrastim), which had non–sole preferred strategies, saw greater declines, with their biosimilars surpassing them in market share within 2 years. Additionally, originators with sole preferred coverage experienced significant reductions in average sales prices, while those with non–sole preferred strategies maintained higher prices. The authors highlighted the importance of ongoing policy efforts to promote biosimilar adoption and suggested further research into how pricing regulations may impact the viability of biosimilars in the market.

An observational study on patient satisfaction with adalimumab products for inflammatory bowel disease found a generally high level of satisfaction among participants. The survey, involving 941 patients treated with various adalimumab products, indicated higher satisfaction scores for Humira (reference adalimumab) compared with adalimumab biosimilars Hulio and Amgevita, particularly regarding the injection device.

Injection site reactions were reported by 32% of patients, with higher rates for Amsparity and Imraldi (2 other adalimumab biosimilars). The study concluded that while overall satisfaction with adalimumab is high, variations exist among products. The authors emphasized the importance of considering patient satisfaction in treatment choices, as it is linked to better adherence and compliance.