Improving Biosimilar Access Through Global Regulatory Convergence

Achieving global regulatory harmonization for biosimilar vaccines and immunotherapies is crucial to improving market access, reducing costs, and enhancing patient outcomes, according to a recent commentary emphasizing the need to address regulatory disparities.

The commentary, published in Human Vaccines & Immunotherapeutics, was written to address the challenges and disparities in global regulatory frameworks for biosimilars, highlighting how these inconsistencies hinder development, increase costs, and delay access to affordable treatments.

Biosimilar adoption varies globally, with Europe leading the way while the US lags due to knowledge gaps among health care professionals. Regulatory disparities and complex approval processes further hinder biosimilar development, emphasizing the need for global regulatory harmonization, streamlined guidelines, and international collaboration to enhance accessibility, reduce costs, and foster innovation in the biopharmaceutical industry.

Additionally, with the development of a biosimilar costing companies between $100 million to $250 million and taking 7 to 8 years, regulatory disparities can add an additional burden to developers, making it harder for companies to recoup their investment when launch delays arise.²

Current Biosimilar Regulatory Landscape

The biosimilar development process includes analytical, functional, nonclinical evaluations, and clinical trials, ensuring similarity in quality, safety, and efficacy. Similarly, functional analytical studies are pivotal for validating comparability without independently establishing efficacy and safety. However, different countries/regions have different submission requirements to obtain regulatory approval for a biosimilar.

Both the European Medicines Agency (EMA) and the FDA have rigorous approval standards. While the EMA emphasized consistency amongst European Union members, only the FDA demands additional data to obtain interchangeability, which can impact patient accessibility if foregone. Countries in regions like Middle East and North Africa (MENA) countries often align with EMA or FDA standards but adopt various localized frameworks, creating more discrepancies. For example, some countries, like Saudi Arabia, require switching studies for interchangeability, unlike Tunisia and Egypt, where decisions often bypass patient input, impacting market penetration and health care cost savings.

Strategies to improve global regulatory convergence focus on education, building patient trust, sharing information, and fostering international collaboration. Establishing robust pharmacovigilance systems is also essential to ensure the long-term safety and efficacy of biosimilars.

Future efforts by World Health Organization (WHO), International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and regional regulators aim to standardize frameworks. As biosimilars evolve, clearer guidance and streamlined pathways are needed to improve accessibility and support patient-centered care.

Companies spend between $100 million to $250 million and 7 to 8 years developing a biosimilar. Image credit: natali_mis - stock.adobe.com

Benefits of Global Regulatory Harmonization

Harmonizing technical requirements across countries could accelerate drug approval processes globally and locally by establishing uniform regulatory reviews. Additionally, it could reduce redundant testing and allow manufacturers to submit a single comprehensive application, speeding up market access and conserving financial and operational resources. The commentary emphasized that patients benefit from quicker access to novel treatments, leading to improved health outcomes. Harmonized regulations also stimulate market competition, fostering innovation and reducing costs.

Despite progress, global biosimilar harmonization faces hurdles, including inconsistent interchangeability policies, regulatory framework variations, and resource disparities among nations. Differences in approval processes, evaluation standards, and economic factors further complicate alignment, with limited international collaboration and economic disparities hinder the establishment of fair pricing and reimbursement strategies.

“More rapid approval and commercialization of novel medications is made possible by harmonized regulations, which help patients benefit from early access to medications by having more timely treatment options, and hence, better health outcomes. Moreover, harmonized regulations encourage competition in the market, and as businesses compete to provide better, more affordable solutions, this often sparks innovation, benefiting patients and industry,” explained the authors.

Health care systems face challenges at various levels: micro (stakeholder recognition), meso (organizational expertise), and macro (regulatory and economic factors). Health Technology Assessment (HTA) agencies could play a critical role by providing economic and clinical guidance to policymakers. However, variability in HTA evaluations across countries can disrupt consistent decision-making.

The authors pointed to operational issues like ensuring safety, providing education, and managing logistics impact biosimilar integration. Legal and intellectual property barriers, along with capacity-building needs, further delay market entry and limit cost-saving potential.

To achieve harmonization, standardize biosimilar naming, foster international regulatory collaboration, and establish consistent approval processes. An independent council should oversee these efforts, aiming to improve affordability. Involving health care professionals, patient advocates, and industry stakeholders will also be key.

Education for health care providers and regulators will be crucial. The FDA offers resources to improve understanding of biosimilars and their interchangeability. However, broader adoption will require a comprehensive approach that includes clearer regulations, streamlined approval, and market competition.

The commentary concluded, “Harmonizing biosimilar regulations is critical for improving efficient market access, reducing healthcare costs, and enhancing patient outcomes worldwide. Addressing the challenges to achieve global regulatory alignment necessitates collaborative efforts, educational initiatives, and the development of unified standards.”

References

1. Jarab AS, Heshmeh SRA, Meslamani AZA. Bridging the gap: The future of biosimilars regulations. Hum Vaccin Immunother. 2024;20(1):2362450. doi:10.1080/21645515.2024.2362450

2. Blackstone EA. Fuhr JP. The Economics of Biosimilars. Am Health Drug Benefits. 2013;6(8):469-478.