In January 2023, the first biosimilar version of Humira, which is a widely used injectable drug for inflammatory diseases, was approved, marking the end of AbbVie’s two-decade market exclusivity. Humira is used to treat conditions like rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, and it works by targeting certain proteins in the immune system.

In recent years, drug shortages have become a major concern for healthcare systems around the world. The COVID-19 pandemic has only amplified this issue, as the demand for certain drugs has skyrocketed while the supply chain has been disrupted.

You may have never heard of biosimilar drugs and that’s probably because they are not commonly prescribed in the United States even though they have been around for over 20 years. So, what are biosimilar drugs? A biosimilar drug is no different in terms of safety and effectiveness than a biologic product, also known as a reference product, and while highly similar it is not identical.

In the early 2000s, the FDA set up guidelines in the Regulatory Procedures Manual (RPM) that permitted prescription drugs to be imported from other countries if the patient met very strict guidelines. Just stating that the patient needed the drug due to cost savings was not a justification to obtain the drug.