Biosimilars Forum leader: New Humira launches a major test, and why Congress should toss interchangeability

Any comparisons between AbbVie’s multibillion-dollar-per-quarter Humira (adalimumab) and its biosimilar market, and the blockbuster insulins’ biosimilars market can simply point to the need for two prices — in some cases, for each product — a higher one to entice more rebates and PBM coverage, and a handful of significantly discounted adalimumab biosimilars too.

A new report from Samsung Bioepis released this morning shows the disparities in the 12 prices across the eight competitors and Humira so far, with seven biosimilars launching on July 1. Amgen’s adalimumab biosimilar Amjevita launched first in January, but has captured just 4% of AbbVie’s market so far.

Biosimilars Forum executive director Juliana Reed told Endpoints News in an interview that Amjevita and others’ use of two prices make them similar to Biocon’s insulin biosimilar, where the high wholesale acquisition cost (WAC) and list price include the rebates to the PBMs. Manufacturers seeking access to the PBM formularies often have to go with the higher WAC, Reed said.

“The low list or low WAC is having little to no uptake and unfortunately the high-rebate product is having some uptake but really not considerable,” Reed said.

As far as companies seeking an edge on their competitors in this crowded market via an interchangeability designation, Reed said the confusion around interchangeability “has been a hurdle” but from a commercial perspective, it may be helpful if a biosimilar’s market is on the retail side, where the designation can allow for pharmacists to make a substitution to the lower-cost biosimilar without a doctor’s prescription.

“The FDA has made it clear it’s just for pharmacy substitution but it’s not in the statute to define the different levels of quality and safety,” Reed added on the interchangeability designation. “We’ll have to see the numbers come in. When we interviewed payers, they didn’t see it as a game-changer.”

But make no mistake, how the potentially dozen or so competitors battle for Humira turf will be used as a bellwether for determining how much large biopharma and other specialty companies should be investing in these large molecules, Reed said. She noted that she’s concerned given the fierce dynamics.

“One of the concerns we have is Medicare is not reinforcing uptake of biosimilars and lowering costs for patients,” Reed said. “And the PBMs are not doing it. And those are market dynamics that are out of our control and those dynamics need to change.”

As it stands, brands may have opaque agreement that guarantees volume in exchange for a retroactive rebate at the end of the year, the Forum notes in its one-pager on the adalimumab biosimilar launches.

As far as AbbVie losing market share, Reed said the sheer number of competitors should force some brand erosion in the near term.

“The question is will it be a lot or a small amount, and that’s up to the PBMs,” she added, noting the dominant three players controlling 80% of the PBM market. “There needs to be changes to how PBMs can limit access to the market.”

Reed also mentioned that the Biosimilars Forum may soon call on Congress to reevaluate whether the interchangeability designation for biosimilars “is still necessary” as part of wider reforms to the US biosimilars market to try to make it more like Europe, where all biosimilars are considered interchangeable.

“We are sort of in the middle school years. We’ve got 10 years in here, and we’re maturing,” Reed said.

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