Whitepaper - Biotechnology

Rapidly Evolving Biosimilars Market to Establish Sustainable Healthcare System

Biologics have developed a strong position in the pharmaceutical industry over the last three decades, encouraging stakeholders to introduce advanced substitute therapies for incurable diseases, including autoimmune diseases and cancer. Biosimilars are an innovative form of biologics similar to reference biologics with no clinically meaningful differences from their existing reference product. Biosimilars are a relatively lower-cost version of biologics and are approved by regulatory authorities as products for curing certain illnesses. Since the entry of the first biosimilar in the US market in 2015, nearly 40 biosimilars have been approved as of 2022, reflecting remarkable opportunities for the industry's growth amid the growing cost burden in the pharmaceutical space. The approval of biosimilars is built on existing safety and efficacy data and scientific knowledge of the reference biologic gained during its clinical use. Thus, fewer clinical research data is needed for biosimilars and does not require the execution of the entire clinical development program of the reference medicine. According to IQVIA, biosimilars achieved 20% market share by the end of 2019, and ~50% of biologic market share is likely to face biosimilar competition in the coming years. 

Europe has pioneered the biosimilars industry and constructed appropriate regulations. The region has approved the highest number of biosimilars globally, amassing their considerable safety and use experience. The uptake of biosimilars in the European market has been slow and mixed since the last decade, allowing biopharmaceutical giants time to furnish defensive strategies. Furthermore, the discounts for biosimilars are not as drastic as 70–90%, unlike generic pharmaceuticals, which is a potential influential factor for entering this market space. Despite the COVID-19 pandemic, the volume of biosimilar prescriptions generated significant savings from biosimilar competition in 2020, with the list price savings accounting for over EUR 5.7 billion in savings as compared to the pre-biosimilar cost of their originator biologics. Even though Europe's track record has been proven in the biosimilars market, the US owns unique regulatory characteristics expected to create distinct opportunities in the country.

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