FDA Grants Interchangeable Status to Humira Biosimilar; Payers Should Prepare Now for 2023 Launches

by Angela Maas

Less than three months after granting interchangeable status to a biosimilar for the first time, the FDA has approved that status for a second biosimilar, Boehringer Ingelheim Pharmaceuticals, Inc.’s Cyltezo (adalimumab-adbm). It and multiple other biosimilars of AbbVie Inc.’s Humira (adalimumab) are slated to come onto the U.S. market in 2023, but plans should be preparing now for the drugs’ launches, say industry experts. Still, a handful of factors could pose an issue with the agents’ taking market share from the reference product.

Cyltezo Scores ‘Groundbreaking’ Nod

• On Oct. 15, 2021, the FDA granted interchangeability status to Cyltezo for all of its approved uses.
• Per the Biologics Price Competition and Innovation Act (BPCIA) of 2009, the drug will have one year of exclusivity upon launch during which the FDA cannot grant interchangeable status to another Humira biosimilar.
• “Overall, the granting of interchangeable status for Cyltezo is momentous and groundbreaking,” declares Lynn Nishida, R.Ph., head of clinical operations at Evio, “not to mention that it will allow more flexibility of options to be considered to that of Humira, since pharmacies may be able to substitute Cyltezo for Humira (as a least costly option),” barring state law restrictions.

What Could Dampen Uptake?

• “Factors such as product concentration, needle gauge size, delivery device design, excipients and market launch dates will all determine how impactful these products will be in the marketplace,” states Robert Kinyua, Pharm.D., senior director of clinical program development at Prime Therapeutics LLC.
• Cyltezo and the other biosimilars are approved in doses administered at a lower concentration that have largely been replaced in Humira prescribing.
• Renee Rayburg, R.Ph., vice president of specialty clinical consulting at Pharmaceutical Strategies Group, points out that Cyltezo is interchangeable with only the lower concentration Humira formulations, and the drug is not interchangeable with AbbVie’s citrate-free Humira formulation, which could make providers and patients less likely to want to switch.
• Alvotech, Celltrion Healthcare and Amgen are developing higher concentration Humira biosimilars for the U.S. market.

What Should Payers Do Now?

• Payers need to understand how the biosimilars are different from each other, “what factors are most likely to influence prescribers and patients, and what support services manufacturers will offer with their product,” recommends Kinyua.
• In addition, says Rayburg, they’ll want to know the products’ formulations, launch dates, prices and any additional rebates or contracting. “For the PBMs specifically, how will the products be covered, brand vs. biosimilar?” will be important to ask.
• “Payers do need to start looking at their current formularies and preferred products and perform predictive modeling and trend forecasting that includes the introduction of the mix of new biosimilars, accounting for changes in price and timing this appropriately,” Nishida tells AIS Health.

From Radar on Specialty Pharmacy