With the looming patent cliff for biologics, biosimilars are rapidly gaining ground in the US market.
However, there are still many key points worth investors' attention, especially as the impact of more drug pricing policies on pharmaceutical prices may gradually become apparent under the backdrop of sustained US inflation expectations.
<h2>Rapid Growth of the US Biosimilars Market</h2>
A recent market report for the second quarter of 2024 on the US biosimilars market by Samsung Bioepis PDF Report indicates that as of now, the US FDA has approved 48 biosimilars involving 15 reference biologics. Among them, 38 have been officially commercialized. On average, three years after market launch, biosimilars hold a 53% market share.
Biosimilars are divided into two major camps: fast penetration and slow penetration.
In the fields of oncology, ophthalmology, and long-acting granulocyte colony-stimulating factor, biosimilars have made rapid progress, with an average market share of 75% after three years of market presence. In contrast, biosimilars in the fields of immunology, short-acting granulocyte colony-stimulating factor, erythropoietin, and insulin have progressed slowly, with a three-year market share of only 23%.
In the fast-penetrating field, biosimilars of oncology drugs Herceptin, Avastin, and Lucentis have shown remarkable performance. Taking Herceptin as an example, by the fourth quarter of 2023, biosimilars of Herceptin had already captured an 86% market share, with Kanjinti standing out with a 31% share.
Biosimilars of Avastin and Lucentis had already caught up with the reference drugs by the end of 2020. Two biosimilars of Avastin, Byooviz and Cimerli, have captured 41% of the market. Surprisingly, despite Cimerli having a higher average selling price (ASP), its market share is rapidly increasing
<h2>Remicade still holds 96% market share, BI forced to lay off employees</h2>
However, in the field of immunology, the &#34;drug king&#34; Remicade has shown strong resistance.
Despite Remicade's 10 biosimilar drugs being approved for listing since last year, the penetration rate is far below expectations.
Specifically, as of February this year, the market share of these biosimilar drugs has only slightly increased from 2% in the previous quarter to 4%. AbbVie still firmly controls the market for adalimumab with years of accumulated prescribing habits among doctors and patients, as well as significant rebates to Pharmacy Benefit Managers (PBMs).
It is worth noting that although the wholesale acquisition cost (WAC) of adalimumab biosimilars is 55-86% cheaper than Remicade, with discounts as high as 86% for Hadlima and Yusimry, these competitively priced biosimilar drugs still struggle to quickly challenge Remicade's market dominance.
Under Remicade's high pricing and rebate incentives, 4 brands including Cyltezo have adopted dual or multiple pricing strategies, attempting to seize market share through flexible pricing, but with little success. This situation highlights Remicade's strong market influence in the field of immunology, leading to Boehringer Ingelheim (BI)'s adalimumab biosimilar Cyltezo underperforming in sales, prompting the company to announce layoffs in the United States to address the challenges.
According to IQVIA's analysis report, the biggest obstacle limiting the penetration of Remicade biosimilars lies in Pharmacy Benefit Managers (PBMs). The report indicates that Remicade biosimilars have significantly lower market share in the three major PBMs (CVS Caremark, Express Scripts, OptumRx) compared to smaller PBMs.
Wall Street News·Jianzhi Research has detailed the pricing mechanism of Remicade and biosimilars in the article &#34;Biosimilars going to the U.S., reaching a turning point | Jianzhi Research&#34;. Remicade's rebates to PBMs are roughly $3800, accounting for as much as 54% of the end price.
According to IQVIA's estimation, if all Remicade patients were switched to biosimilars, the U.S. healthcare system could save up to $6 billion annually on drug expenses, but as PBMs mainly profit from high rebates on originator drugs, this switch would result in about an 84% loss in profit for the three major PBMs, hence they have no incentive to promote the use of Remicade biosimilars
To maintain the monopoly position of Humira, AbbVie not only provides huge rebates to PBMs, but also actively expands patient assistance programs to reduce patient out-of-pocket costs through multiple copay reduction methods, thereby improving medication adherence.
Furthermore, AbbVie also collaborates with third-party organizations such as the Pharmacy Benefit Management Institute (PBMI) to promote the efficacy and safety data of Humira to doctors and patients, enhancing brand awareness. These comprehensive measures further solidify Humira's market position.
<h2>Persistent inflation in the United States, multiple drug pricing reduction bills will gradually impact the market</h2>
Under the current &#34;rebate trap&#34; mechanism, PBMs tend to include high-priced drugs in the insurance drug list rather than lower-priced drugs with higher clinical value.
On one hand, this artificially raises patient out-of-pocket costs and the burden on insurance funds; on the other hand, due to the extreme lack of transparency in rebates, PBMs can pocket a portion of the rebates paid by pharmaceutical companies, driving up drug prices.
The emergence of biosimilars has exposed this mechanism. Because biosimilars provide clinical value equivalent to the original drugs at a significantly discounted price, without the need to provide PBMs with high rebates like original drugs, they pose a direct challenge to the interests of PBMs.
Most importantly, Jianzhi Research mentioned in the article &#34;Negotiating High Drug Prices in the United States, What You Need to Know | Jianzhi Research&#34; that, not only are insurance negotiations important, but the transparency of PBM prices is also a focus of observation for US drug policies this year.
In fact, over the past six years, the net income of large pharmaceutical companies has continued to decline. The reasons behind this phenomenon are complex, but one important factor is the widening gap between drug prices and actual revenue of pharmaceutical companies, exposing the increasing influence of PBMs in the US drug pricing system.
Although PBMs and original drug companies currently have the upper hand in the battle against biosimilars like Adalimumab, as biosimilars continue to accumulate real-world data, their efficacy and safety advantages will become more apparent. At the same time, with increasing insurance pressure, regulatory policies will also tilt towards favoring biosimilars.
The &#34;Inflation Reduction Act&#34; passed by the United States in August 2022 authorizes Medicare to negotiate directly with pharmaceutical companies for the first time. Although biosimilars are not currently included in the negotiation scope, the bill also raises the payment standard for qualifying biosimilars to 8% of the original drug's ASP, which helps increase the willingness of medical institutions to use biosimilars.
On the other hand, after the implementation of the bill, the reduced income of original drug companies may raise drug list prices, highlighting the price advantage of biosimilars
Overall, the competitive pressure facing Xiumile will be a long-term tug-of-war, and whether its market position can remain stable remains to be seen.
For pharmaceutical companies like Xiumile, in addition to price wars, the key factor determining whether biosimilars can successfully challenge Xiumile lies in how to win the trust of doctors and patients, and reach favorable cooperation agreements with PBMs.
However, for the capital market, it is necessary to pay attention to the impact of various price reduction policies in the United States on the market, and the gradual start of changes in long-term pricing mechanisms

ABBV

Biosimilars have a significant market share in the United States, but the impact of drug pricing policies on pharmaceutical prices may gradually become apparent. Biosimilars in areas such as oncology, ophthalmology, and long-acting granulocyte colony-stimulating factor have a higher market share, while areas like immunology and short-acting granulocyte colony-stimulating factor have a lower market share. Remicade still holds a 96% market share, but its biosimilar penetration rate is relatively low. Overall, the outlook for the biosimilars market is promising

Xiumeile still holds a 96% market share, how much longer until the dream of price reduction for biosimilars? | Jianzhi Research