The Largest LOE Event In US Pharma History

By Dean Rudge

The loss of exclusivity (LOE) for pharmaceutical products is a significant event. AbbVie's blockbuster drug Humira (adalimumab) is approaching LOE, which will have an impact on the pharmaceutical market.

Humira's LOE is expected to be the largest event of its kind in the pharmaceutical market. Once the period of LOE for pharmaceuticals begins, other companies can introduce biosimilar versions of Humira into the market, providing more affordable treatment options for patients. This event will shape the future of biosimilar competition and impact the availability and pricing of anti-tumor necrosis factor biologics.

Several companies are preparing to launch their biosimilar versions of Humira in 2023. However, there might be uncertainty surrounding Alvotech's entry into the market due to a delay caused by a COVID-related inspection deferral.

For biosimilar sponsors, obtaining interchangeability designation from the FDA and offering the higher-strength 100mg/ml formulation of Humira are key considerations. Payers will play a significant role in the market evolution, and biosimilar sponsors are anticipating a competitive landscape and potential price erosion.

Overall, the LOE event for Humira represents a crucial turning point in the pharmaceutical industry, with implications for biosimilar competition, treatment accessibility, and affordability.