May 10, 2024

With differences in manufacturing, biologic medications do not have generic medications after a brand name patent is lost, instead, they have biosimilars. Biosimilars are biologic medications that are highly similar to and have no clinically meaningful differences from an existing FDA-approved biologic.  

A brief background on biosimilars 

Biosimilars have been found safe and effective in dozens of trials and real-world studies over the years. While some common medications, like insulin, technically have biosimilars, more biologics and biosimilars are found in the specialty medications space.  

The first biosimilars launched in 2016, however it was not until 2023 that the first meaningful specialty biosimilar was available for home use on the pharmacy benefit. After years of standing on top of the global sales market and setting records for yearly sales, the biosimilars of Humira (adalimumab) are the first test of biosimilars for specialty medications in the pharmacy benefit space.  

2023 Impact

While the first Humira biosimilar, Amjevita, launched on 1/31/23, the impact on biosimilar utilization and cost was minimal. Ten additional Humira biosimilars were launched during 2023, but they too did not make an impact.  

Complexity in pricing, regulatory red tape for interchangeability, provider and patient acceptance, and PBM (Pharmacy Benefit Manager) formulary decisions all slowed the uptake of these cost saving biosimilars. In November of 2023, Humira still held on to 99% of the market share for a predicted $6 billion in missed savings opportunities.  

Pricing 

Humira is available at a yearly price of $90,000. This is not the net price. In fact, rebates have steadily climbed in this space to 50-60% according to many reports. The biosimilar products came out with different pricing structures from a 5% discount with rebates still being offered (high WAC) to 80-85% discount upfront (low WAC).  

The truly low WAC products are the lowest net price products typically, but in 2023, the number of PBMs preferring these products was minimal due to the impact on rebates not just for Humira, but for other products from the same manufacturers.  

Other Developments 

Arguably the most talked about development in this space was Mark Cuban Cost Plus pharmacy. Price fluctuates, but at $7,200 per year currently, or 92% off the Humira brand price, use of this product can lead to significant savings for a plan. However, not all PBMs have a way to, or are interested in, taking advantage of this pricing.  

2024 Impact So Far

2024 brought even more Humira biosimilar approvals and launches. This includes Simlandi, the first high concentration interchangeable product at the 40mg/0.4 ml strength, which accounts for over 85% of all Humira prescriptions. While this is progress, Simlandi was given a year of exclusivity specifically for interchangeability adding to complexity in this space. Other biosimilars in this popular concentration and strength will not be able to be treated as interchangeable until May 2025.  

2024 also brought about Hyrimoz. This product is unique as it is co-manufactured by CVS Health, who also owns a PBM. This is the first step in their goal to manufacture their own biosimilar product. While a PBM manufacturing biosimilar products adds to the complexity and PBM profits in this space, it has also led to a shift in market share for Humira.  

The biosimilar market share was 5% at the time that CVS Caremark removed Humira from their formulary. Within 5 days of this move, the biosimilar market share jumped to 36% across the country. With the majority of the new biosimilar scripts coming in the form of Hyrimoz, the jump is being credited to the removal of Humira from the CVS Caremark formulary. 

Future Direction

The second half of 2024 will bring forth more PBMs shifting from Humira to biosimilar products with other mid-market PBMs intending on removing Humira as a preferred product. While this is welcome progress, some PBMs are still intent on keeping Humira as a preferred product.  

The approach and launch of Humira biosimilars will be watched closely as we approach 2025 and the next big pharmacy benefit biosimilar launch, Stelara. While overall utilization is lower than Humira, the yearly price is up to $181,000 per year leading to additional opportunity for savings. The biosimilar launch was delayed previously but expecting the first biosimilar, Wezlana to launch January 1, 2025, with Selarsdi and up to two other biosimilars to launch in February 2025.  

The hope is that pharmacy benefits space will use lessons learned with Humira biosimilars to lead to a much quicker shift in market share from Stelara to biosimilar products.  

 

In the biosimilar landscape, change is always afoot. If you have any questions about Humira biosimilars, or any other pharmacy benefit concerns, one of our experts would be happy to assist you. Simply click the link below to get in touch. 

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