Priming the Pump for Interchangeable Biosimilars By Preferencing Semglee

The biosimilars market may be entering a new phase. The FDA has started labeling biosimilars as “interchangeable,” an official designation that means the biosimilar can be substituted for the brand-name product at the pharmacy level without consulting with the prescribing physician about the change. That kind of swapping of the brand-name drug for the cheaper alternative played a role in increasing the use of generics among small-molecule drug and it could tip the balance in favor of biosimilars among the biologics.

In July, the FDA gave Semglee (insulin glargine-yfgn) the interchangeable designation for its reference, brand-name product, Lantus (insulin glargine). Last month, it approved an interchangeable designation for Cyltezo (adalimumab-adbm), a biosimilar to Humira (adalimumab). Like other Humira biosimilars, Cyltezo is not scheduled to go on the market till 2023.

State pharmacies may affect interchangeability and how fast interchangeable biosimilars catch on. PBM formularies and whether the interchangeable biosimilars are given a preferred status is another variable. Although biosimilars are ostensibly priced lower than their brand-name counterparts, the rebates that PBMs receive from drugmakers adds a wrinkle. In some instances, PBMs may stick with the brand-name drugs because, once rebates are factored in, they make more money if a brand-name drug is prescribed.

Perhaps to assuage those concerns and to send a signal that it was ready to get behind interchangeable biosimilars, Prime Therapeutics announced this week that to give Semglee and its generic version a preferred spot on its national formulary next year.

Kelly Pokuta

“This just strengthens our message that Prime is committed to biosimilars,especially as we start to see more these interchangeable ones,” said Kelly Pokuta, Pharm.D., vice president and chief trade relations officer at Prime, in an interview with Managed Healthcare Executive.®

Prime made the announcement on Wednesday. Prime, which is headquartered insuburban Minneapolis, manages pharmacy benefits for 23 Blues plans. It will be up to the individual Blues plans whether they want to follow the national formulary.

“This has garnered a lot of interest from our clients, and they are all in the process of discussing if they want to adopt it or not,” Pokuta told MHE “We feel there’s going to be a pretty high adoption rate on this because it is dealing with the insulin category and, as you can imagine, the diabetes category is so big as far as cost and number of patients.”

Pokuta noted that the companies that sell insulin products tend to pay large rebates.

“With the Semglee opportunity and insulin glargine opportunity — the unbranded version of Semglee — it provides us with a true low net cost opportunity that gives us better economics than if we stuck with the brand,” Pokuta said. “This is definitely a step in the right direction in how you can take a heavily rebated category and implement a biosimilar successfully.’’

She also described formulary preference for Semglee and its unbranded version as “setting the stages for this interchangeability idea” and noted the interchangeable designation of Cyltezo.

In May, Prime announced the launching of a medical management program called MedDrive that has greater biosimilar adoption as one of its central features.