Hadlima is Getting Into Interchangeability Game


Hadlima is scheduled to be on to the market in July 2023. In an interview with Managed Healthcare Executive®, a Samsung Bioepis executive says data on Hadlima’s interchangeability won’t be ready till 2024.

Third of four parts

There’s been a lot of back and forth about how much consideration should be given to interchangeability when it comes to biosimilars, their efficacy and their safety. It is sound and fury signifying something or nothing to worry about?

Regardless, some survey data suggests that interchangeability is an important factor in how biosimilars are perceived — how similar they are to their reference products — and, therefore, a critical piece of the puzzle to their commercial success.

The interchangeability issue may loom especially large for the biosimilars to Humira (adalimumab).

After being bottled up by patent disputes and other issues, a flood of seven (and perhaps as many as 11) Humira biosimilars may hit the market in 2023, possibly giving Humira, the all-time sales leader among pharmaceutical products, some competition for the first time.

Tony Hagen, a freelance writer and a regular contributor to Managed Healthcare Executive®, recently interviewed Tom Newcomer, head of U.S. market access for Samsung Bioepis, which is planning to have its Humira biosimilar, Hadlima (adalimumab-bwwd) on the market midway through 2023.

In this segment of the extensive interview, Hagen notes that the FDA has said that there is “no clinical difference” between an interchangeable biosimilar and a standard biosimilar. He and Newcomer discuss the results of a recent Vizient survey of healthcare decision-makers that suggested, nevertheless, that interchangeability — along with price and formulary placement — will factor into the acceptance of biosimilars, uptake and sales.

Newcomer says, yes, Samsung Bioepis has decided to pursue the interchangeable designation for Hadlima.

“We expect to have data on (Hadlima’s) interchangeability in 2024,” Newcomer says. “So we feel very well positioned to meet the transitioning market at that time.”

Newcomer also talks about the difference between the dispensing of biosimilars and the prescribing of them in his conversation with Hagen, and says interchangeability’s effect will vary between them.

Newcomer’s concluding statement:“We know that whether the interchangeable designation is there or not, it is the same biosimilar.”

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