Biosimilars face challenges & type 2 diabetes drugs show cardiovascular & renal benefits

Kyle Herndon headshot
Kyle Herndon, PharmD, MBA, BCPS

Key takeaways from the American College of Clinical Pharmacy (ACCP) annual meeting in October 2019.


I attended the ACCP meeting to present a poster on a case report involving an infliximab biosimilar, Renflexis, from when I was a post-graduate year one pharmacy resident at the Memphis VA Medical Center. Coincidentally, biosimilars were a hot topic at the meeting. Biosimilars represent a significant cost savings opportunity for the entire healthcare system, but their integration is facing challenges:

  • Only 14 of the 26 biosimilars approved by the Food and Drug Administration (FDA) are readily available in the U.S. market. While most drugs take an average of four to six weeks to go from FDA approval to market, biosimilars are being held up in strategic patent litigation by reference drug companies and are taking about 1.5 years, though it can be much longer. Erelzi, biosimilar to Enbrel, was FDA approved in 2016. But due to patent litigation settlements, Enbrel is unlikely to see biosimilar competition until 2029.
  • The challenges for biosimilars don’t end once they finally reach the market. Reference biological drug companies may increase the rebates they pay to third-party insurance companies or pharmacy benefit managers to incentivize continued use of their products once biosimilars are introduced.

Type 2 diabetes & cardiovascular & renal outcomes

The FDA released guidance in 2008 for new diabetic drug development after evidence that a class of medications led to potentially harmful cardiovascular outcomes when used to treat type 2 diabetes. Since then, some newly introduced antidiabetic drugs have shown to pose no increased risk, but rather positive benefits in terms of cardiovascular and renal disease:

  • Glucagon-like peptide-1 (GLP-1) receptor agonists lower hemoglobin A1c by mimicking the hormone GLP-1. While not all drugs in this class have demonstrated benefit in cardiovascular and renal outcomes, liraglutide, semaglutide and dulaglutide have and are recommended in the 2019 American Diabetes Association (ADA) guidelines. So far, this class has been limited to subcutaneous formulations, but clinical trials of oral formulations are underway.
  • Sodium-glucose cotransporter 2 (SGLT-2) inhibitors lower blood sugar by reducing reabsorption of filtered glucose in the kidneys, which increases urinary glucose excretion. The SGLT-2 inhibitors that have shown cardiovascular benefit are empagliflozin, canagliflozin (FDA approval for diabetic nephropathy) and dapagliflozin (FDA approval to reduce heart failure hospitalizations). Due to the drugs’ effect on fluid status, it is hypothesized that these medications may play a future significant role in the treatment of congestive heart failure.

Attending the ACCP annual meeting is just one of the ways in which HealthTrust stays informed of the latest developments in the pharmacy space. We strive to keep members aware of the pharmaceutical advancements that will impact their patients.

At the time of this writing, Kyle Herndon, PharmD, MBA, BCPS, was a PGY-2 Resident in Corporate Pharmacy Leadership at HealthTrust.


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