The complex properties of biologics underline the challenges to develop follow-on products after the expiry of patent and regulatory data protection of the innovator product. To this end, a dedicated route for regulatory approval of follow-on biologics has been established called the ‘biosimilar’ pathway, which involves a distinct regulatory approach that addresses the specific needs of biologics, as compared to small-molecule generics.
The biosimilar approach involves a robust comparability exercise to prove that the follow-on biologic is clinically equivalent to the innovator product and does not compromise on safety and efficacy. Although the development of biosimilar seems simpler compared to the development of an innovative medicine, a study by Klein et al 2023 demonstrated that among 304 biosimilars submitted to different global regulatory agencies, only 67 were approved.
Interesting, the same study showed that of the 304 biosimilars analyzed, the majority are manufactured in India (78 [25.7%]) and China (62 [20.4%]), followed by Russia (25 [8.2%]), South Korea (25 [8.2%]), Iran (23 [7.6%]) and Argentina (20 [6.6%]). Only seven follow-on biologics from in India and one from China are approved as biosimilars in any of the five major biosimilar countries. In addition, whereas a large proportion of Indian manufacturers supply their products to markets beyond India, this study found that the majority of follow-on biologics manufactured in China, Russia and Iran are only approved for the local market.
While biosimilars offer numerous benefits, it's essential to navigate regulatory and scientific challenges to ensure their safety and effectiveness. As the biosimilar market continues to evolve, it is likely to play an increasingly important role in shaping the future of biologic therapies and healthcare systems globally. In the years following the first official approval of a biosimilar in 2006, the European Union (EU) approval of Omnitrope®, regulatory systems of the five major markets, i.e. the EU, USA, Canada (CA), Australia (AU) and Japan (JP), have implemented biosimilar pathways and the World Health Organization (WHO) has defined globally recognized standards.
Last, we listed several reasons for why biosimilars hold significant importance in the field of healthcare and pharmaceuticals:
- Increased Access to Biologic Therapies: Biosimilars offer a more affordable alternative to their reference biologic counterparts. This increased affordability can expand patient access to important and often life-saving biologic therapies.
- Cost Savings for Healthcare Systems: The introduction of biosimilars into the market can lead to cost savings for healthcare systems, insurers, and patients. By providing a lower-cost alternative to originator biologics, biosimilars contribute to cost containment in healthcare spending.
- Competition and Market Dynamics: The presence of biosimilars introduces healthy competition into the market. Competition can lead to lower prices, improved patient access, and increased innovation as companies strive to differentiate their products.
- Sustainability of Healthcare Systems: The rising costs of biologics can strain healthcare budgets. Biosimilars can contribute to the sustainability of healthcare systems by offering cost-effective alternatives, allowing for the allocation of resources to other healthcare needs.
- Innovation and Research Incentives: The availability of biosimilars can stimulate innovation and research. As originator biologics face biosimilar competition, manufacturers may invest in research and development to create new and more advanced biologic therapies.
- Global Health Impact: Biosimilars can have a positive impact on global health by making essential biologic treatments more accessible in regions with limited resources. Increased affordability may lead to broader availability of these therapies on a global scale.
- Patient Choice and Empowerment: Biosimilars provide patients and healthcare providers with more options for treatment. Patients may have the choice to receive the reference biologic or a biosimilar based on factors such as cost, convenience, or individual preferences.
- Biologic Lifecycle Management: For originator biologic manufacturers, developing biosimilars can be a strategic approach to managing the product lifecycle. This may involve extending the commercial life of a biologic by offering both the originator product and its biosimilar.
- Market Access and Competition for Developers: For biosimilar developers, entering the market provides an opportunity to compete and gain a share of the market. The successful development and commercialization of biosimilars can be financially rewarding for these companies.
- Regulatory Pathway for Approval: The establishment of regulatory pathways for biosimilar approval provides a framework for ensuring their safety, efficacy, and similarity to the reference biologic. This regulatory framework helps build confidence among healthcare professionals and patients.