Market Challenges: Regulations and approval processes

Global pegfilgrastim biosimilars market growth can be hampered by various regulatory challenges. Biosimilars are governed by strict regulations related to the approval process and regulations differ from country to country. Meeting the extensive approval criteria set forth by regulatory bodies for biosimilars can be a long and costly process. For instance, in the U.S., the approval pathway for biosimilars is complicated and requires extensive analytical, animal, and clinical studies. Moreover, the regulatory requirements are often ambiguous regarding the extent of similarity evidence required. Such unclear regulations prolong the approval timeline and increase costs for biosimilar companies. Regulations in other regions such as Europe and Japan are also elaborate, which makes the overall approval process time-consuming and capital intensive. The non-uniform regulatory framework across various markets introduces inefficiencies in the approval cycle. These regulatory challenges add to the development and operational costs, which can deter biosimilar manufacturers.

Market Opportunities: Public awareness about benefits of biosimilars

Public awareness about the benefits of biosimilars can offer opportunities for growth of global pegfilgrastim biosimilars market. Biosimilars offer clinically equivalent treatment alternatives to originator biologics at reduced costs, which can significantly expand patient access to important therapies. However, awareness about the safety, efficacy and cost advantages of biosimilars remains relatively low among physicians and patients alike. According to the data from World Health Organization, only 14% of Americans and 10% of Europeans are very or somewhat familiar with biosimilars. Increased education and information dissemination campaigns by regulatory bodies, hospitals, non-profit organizations as well as biosimilar manufacturers have the potential to drive wider acceptance and adoption of biosimilars. For instance, the European Commission has allocated funding for initiatives targeted at improving knowledge about biosimilars among patients and health professionals in member states from 2020-2022. Comprehensive information on the rigorous development process, stringent regulatory pathway and demonstrated similarity to reference products that biosimilars must undergo can help address concerns around their use. This could help providers feel more comfortable in regularly substituting and interchanging therapies with approved pegfilgrastim biosimilars. As familiarity and confidence in biosimilars increases, their potential to deliver significant treatment cost savings will become increasingly attractive to healthcare systems, insurers and providers. The COVID-19 pandemic has placed considerable strain on global healthcare budgets. Expanding the uptake of approved, clinically equivalent and lower cost biosimilars could help free up financial resources that can be reallocated to advance care for other patient populations.