"Biologics are not identical medications – even branded biologics, like Humira, which has been on the market for 20 years. The Humira we have today is not the exact same Humira that we had when that product was approved back in 2012." — Steven Lucio, PharmD, Vizient Senior Principal of Pharmacy Solutions
Biosimilar medications may be similar to name-brand biologics, but Steven Lucio, the man who has studied these drugs for over a decade, is a brand all his own.
A better healthcare for all
As Vizient Senior Principal of Pharmacy Solutions, Lucio heads up the Center for Pharmacy Practice Excellence (CPPE) where he and his team focus on a wide range of clinical and operational pharmacy disciplines, including mitigating the impact of drug shortages, forecasting the cost and use of new drugs and drug classes, promoting evidence-based medicine practices, supporting members with regulatory adherence and advocacy and advancing the continued evaluation and use of biosimilars.
Lucio's team also was instrumental in creating a list of essential drugs needed for critical care for the Novaplus and Novaplus Enhanced Supply, both of which enhance the availability of crucial drugs for healthcare organizations. The team also played an influential role in helping launch the End Drug Shortages Alliance (EDSA), an independent collaboration of healthcare industry stakeholders dedicated to solving pharmaceutical supply challenges that disrupt access to medications in the U.S., in November 2021.
"At this very moment, if I could immediately eradicate all drug and supply shortages, I would do that because it is unfortunate how much time is spent dealing with interruptions of pharmaceuticals or IV solutions – or, really, all manner of things that are essential to taking care of patients," said Lucio. "It's time consuming; it's costly. A few years ago, we did a survey of our members regarding how much time they spend dealing with drug shortages and based on the data gathered prior to the pandemic, the U.S. health system spends an average of $360 million on labor annually on drug shortages."
More recently, Lucio and his team have shared their expertise to help educate government agencies and fellow healthcare professionals about biosimilars and their use. It's a particularly hot topic in pharmacy right now due to the pending patent expiration of the anti-inflammatory drug adalimumab, or Humira, January 31, 2023.
"Humira, which is used to treat many inflammatory conditions in adults as well as Crohn's Disease, is the most expensive drug of all time. It generates more revenue than all 32 NFL teams and is very much an example of how prices can increase when a manufacturer doesn't have product competition," said Dan Kistner, Vizient group senior vice president, pharmacy solutions. "That's where these biosimilars come in. Biosimilars can be the single largest contributor to lowering the cost of drugs in our country if they are implemented and adopted into U.S. healthcare."
As the market gears up for several adalimumab biosimilars to debut in 2023, Lucio has hosted countless educational workshops and seminars and even written a book, "Biosimilars and Biologics: Implementation and Monitoring in a Healthcare Setting," discussing the importance of biosimilars and biologics in the pharmaceutical industry. ?
A biosimilar drug is a medicine that is close in structure to a biologic medicine, which is made using a living organism like cells, yeast or bacteria. It's a relatively new product in the market, which is why a good deal of Lucio's time is spent educating healthcare organizations and clinicians about what makes a biosimilar a biosimilar, why they're important, and how they work.
"Biologic medications and their molecules are very complicated," said Lucio. "They're much larger and they're inherently variable."
That complexity and variability make biosimilars different from generic medications, which are exact replicas of a branded drug. Since biologic drugs, like Humira, are based on a biologic material that is ever-changing, there's no way to make a biosimilar identical to its branded counterpart in the same way a generic is to its branded counterpart.
WATCH: Steven breaks down biosimilars
"Biologics are not identical medications – even branded biologics, like Humira," said Lucio. "Humira has been on the market for 20 years; the Humira we have today is not the exact same Humira that we had when that product was approved back in 2012."
Manufacturers are creating molecules that are biologically similar to the brand drug's originator molecule, but they're not identical.
"In order to approve a biosimilar, the FDA must discern with high confidence that the biosimilar molecules are going to work in the same way as the branded drug," said Lucio. "This discernment is what also helps determine whether a biosimilar can be used interchangeably with the branded version of the drug."
Biosimilar interchangeability would allow a pharmacist to dispense a biosimilar in place of a branded biologic, similar to what occurs with generic drugs. However, this designation requires additional study and documentation provided by the manufacturer to the FDA. To date, only two biosimilars, one of which is yet to be marketed, have received the interchangeability designation.
WATCH: Steven talks interchangeability
"It's important to note that a biosimilar that is interchangeable, compared to one that is not, doesn't mean that the interchangeable one is inherently better," said Lucio. "All it means is that the manufacturer has provided more data to the FDA to meet that threshold of classifying it as interchangeable."
At least seven new biosimilars for Humira are expected to enter the market in 2023, ensuring the continued discussion around their use and potential interchangeability. Lucio and his team are continuing to provide government agencies, like the FDA, insight into improving the biosimilar review process as well as working diligently to ensure pharmacists, physicians and other clinicians are well-informed and equipped to handle the evolving landscape.
"The first decade of the biosimilar experience provided some success," said Lucio, "but to realize the full potential of biosimilars, the second decade must achieve ever-greater prescribing and use, beginning with Humira competition."