Insights Into Key Events Within The Generics And Biosimilars Space

© Informa UK Ltd 2022 First published in Generics Bulletin, 2022

With AbbVie less than a year away from losing patent exclusivity on its innovation $20.7 billion monoclonal antibody product Humira^® (gross sales in 2021), the United States (US) market is about to change significantly. For several years, biosimilars have established a strong foothold in global pharma markets and the loss of exclusivity for Humira^® will provide further US market penetration opportunities for companies to enter and further risk mitigate their pipeline drug portfolios. At the time of publication, there are currently eight biosimilars poised to launch as competitors to Humira^® once it loses patent protection in 2023. While this is an exciting time for the generics industry, it is also a time of challenge and growth, not only for biosimilar companies, but for manufacturing service providers and regulators as well.

According to IQVIA forecasting data, the biosimilars market grew at a compounded annual growth rate of 78% between 2015 and 2020, and regulatory agencies are now experiencing new growing pains handling an influx of applications. The FDA’s guidance for biosimilar interchangeability also continues to be a hot topic for the industry as companies seek approvals for their drug products. In 2010, the Biologics Price Competition and Innovation Act (BPCIA) was enacted, granting the FDA the power to approve biologics demonstrated to be “biosimilar” to FDA-approved reference drugs. It also enabled the “interchangeability” designation for those biosimilars that conducted additional studies and met certain requirements. This meant that this now “interchangeable” product was certified by the FDA as safe and efficacious as the original branded biologic product. This then allowed an “interchangeable” product to be substituted for the reference product without the involvement of a health care prescriber.

Generic and biosimilar developers continue to experience frustrating delays in gaining FDA approval. In part, these delays stem from the FDA’s difficulty in conducting facility inspections during the pandemic. Recognizing these timeline struggles, the FDA has implemented and is urging the use of abbreviated new drug application (ANDA) pre-submission meetings for complex generic applications which they hope will further streamline the approvals process for these products.

At a 2021 conference, the secretary of India’s Department of Pharmaceuticals noted that the global biosimilars market is estimated to grow to around $70 billion within the next five to six years. Handling this growth will be critical, and regulatory agencies across the globe are recognizing the importance of policy intervention to ensure patient access to these innovative biologic drugs. Having gained greater prominence during the COVID-19 pandemic supplying the drug products to nearly 200 countries, India’s regulatory agencies continue to evolve by implementing reforms designed to streamline their approvals processes further to enable further investment and greater adoption of innovation in the region.

Hence, there is great promise and potential for growth when countries adopt regulatory reforms and new technologies that enable innovative treatments to reach patients sooner. This eBook includes insights into key events within the generics and biosimilars space which are set to influence the landscape. We hope it will further inform and assist you with your current and future business needs.

Milagro E. Lopez,
Director, Generics Market Unit, West Pharmaceutical Services, Inc.