In an interview with MHE, SVP Savitha Vivian said the biosimilars to Humira and Novolog that are expected to be on the market in the next few years could have the kind of impact that proponents of biosimilars have been hoping for.
The FDA has approved 30 biosimilars and 21 have been launched. But it won’t be till biosimilars for some of the more widely prescribed biologics are on the market before biosimilars really start to have a major impact on American healthcare and its cost, according to a top-ranking executive at OptumRx.
“We're still a few years away from the point at which the most widely-utilized … products in the U.S. today will be available as biosimilars,” Savitha Vivian, senior vice president of clinical and formulary Services for OptumRx, said in an interview with Managed Healthcare Executive®. “And that's really what we're looking for, because that's going to enable a more sizable and impactful bottom-line savings.”
One of the most anticipated biosimilar approvals is AbbVie’s Humira (adalimumab), because it’s one of the most prescribed specialty drugs and, among drug, a significant cost driver for many payers, Vivian noted.
While there are no biosimilars to Humira on the market in the U.S., six have been approved by the FDA and may come on the market in 2023. In addition, Alvotech, an Icelandic biosimilars company, says it has the data it needs to convince the FDA to award an “interchangeable” designation for its high-concentration, citrate-free biosimilar candidate (AVT02) to Humira, according to the The Center for Biosimilars®.
Another significant biosimilar launch that is still two to three years away from one for Novo Nordisk’s insulin aspart injection (Novolog), a “highly utilized medication, especially in the outpatient setting,” noted Vivian.Biosimilars for Genentech’s Actemra (tocilizumab), a medication for rheumatoid arthritis and other forms of arthritis, and Stelara (ustekinumab), Janssen’s immunosuppressive drug for plaque psoriasis and psoriatic arthritis, are also two or three years away.
“The good news is that the biosimilar pipeline is still robust, and it continues to grow. And over the past seven years, we've seen the number of biosimilar products increase, on average, by almost 12% per year,” Vivian told MHE. Even though some current biosimilars are in “very select categories that are not highly utilized or utilized on the outpatient side, there are definitely a number of products that are coming to market that are going to have some sizable impact to the biosimilar landscape.”
Uptake of the biosimilars that are currently on the market has been relatively slow, but it is increasing steadily, Vivian observed. Patient and provider comfort with biosimilars is still a “critical barrier” to the adoption of biosimilars, she said.
Switching therapies in patients who are stable on the biosimilar’s reference product to the biosimilar is not typically recommended, according to Vivian. “So from a clinical perspective, we need to be cautious in implementing strategies that force these types of switching.”Instead, she said, “what we really need is data showing that there's really no additional risk from switching therapies in these hard-to-treat or hard-to-control chronic diseases. That's going to really increase the confidence for prescribers to start using biosimilars in … those stable patients.”
Another barrier is a lack of interchangeability in biosimilars, with notable exception of Semglee (insulin glargine-yfgn), which was FDA-approved as biosimilar to, and interchangeable with Lantus (insulin glargine) this summer. In order to demonstrate interchangeability, studies must show there is no additional risk or reduced efficacy if a patient switches back and forth between the interchangeable biosimilar and the reference product.
“So, it addresses the physician concern about switching in hard-to-control disease states,” Vivian said. In addition, interchangeable biosimilars can be substituted for the reference brand product at the pharmacy level, “so that will facilitate the use of biosimilars as well,” Vivian noted. In some states, pharmacy rules and regulations may affect may interchangeability.