Introduction

Biologic drug products are used to treat a variety of serious diseases, including cancer, blindness, rheumatoid arthritis, multiple sclerosis, and diabetes. Biologics, which include antibodies and large proteins, tend to be more complex than traditional small molecule drugs. Biologics are typically manufactured in living cells, and the manufacturing processes can be exquisitely sensitive to small environment changes, for example, in temperature or nutrient content.

In 2015, biologics accounted for 38 percent of U.S. prescription drug spending, and they also accounted for 70 percent of the growth in drug spending from 2010 to 2015.¹In 2017, eight of the top selling drugs were biologics. 

In 2010, Congress passed the Biologics Price Competition and Innovation Act (BPCIA), which established an abbreviated pathway²to market for biosimilars. Biosimilars are often referred to as generic versions of innovator biologics.³To date, the U.S. Food and Drug Administration (FDA) has licensed 11 biosimilars. As part of a broader emphasis on encouraging biologics market competition, the FDA recently published its Biosimilars Action Plan (the BAP).⁴  

Biosimilar Action Plan

The FDA’s BAP contains four key elements:

• improving the efficiency of biosimilar product development and licensing;
• maximizing scientific and regulatory clarity for biosimilar product development;
• improving the understanding of biosimilars among patients, clinicians, and payors; and
• reducing the “gaming” of FDA requirements (as has been seen in traditional generic drug development and regulatory practice) or other attempts to delay unfair competition.

While a comprehensive review of the BAP is beyond the scope of this alert, some key points include:

• enhancing the Purple Book to include more information about approved biologics, including information relating to reference product exclusivity;⁵
• actively exploring the potential for entering into new data sharing agreements with foreign regulators to facilitate an increased use of non-U.S.-licensed comparator products in certain studies to support a biosimilar application;⁶
• providing additional clarity and flexibility for biosimilar developers on analytical approaches to evaluate product structure and function to support a demonstration of biosimilarity; and
• providing additional support for product developers regarding product quality and manufacturing process, including identifying physical product quality attributes that are most critical to evaluate.⁷

Conclusion

The proposed actions outlined in the BAP, in conjunction with initiatives like the Biosimilar Product Development program (BPD program),⁸should facilitate a more transparent path to market for biosimilars. For questions regarding the BAP, or any biosimilar-related questions, please contact David Hoffmeister or any member of the firm’s FDA regulatory practice.

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