The release of the Center for Medicare and Medicaid Services (CMS) average sales price (ASP) figures for the second quarter revealed a startling and dangerous trend for ranibizumab products: up to a 50% drop in pricing from the first quarter of 2025.
As previously reported, Formycon AG’s marketing partner Sandoz has decided to take the leading ranibizumab biosimilar Cimerli off the market. During their earnings call on March 27, Formycon’s executives provided some additional details.
| HCPCS Code | Short Description | HCPCS Code Dosage | Payment Limit |
| Q5124 | inj. Byooviz | 0.1 mg | $85.569 |
| Q5128 | inj. Cimerli | 0.1 mg | $146.761 |
| J2778 | inj. Ranibizumab [Lucentis] | 0.1 mg | $90.414 |
The marketing pause will be substantial—for one year, according to the company. The first-quarter 2025 ASP of Cimerli was reported to be $811 per 0.5 mg in Q1 2025 and falling. In comparison, Byooviz’s ASP was stable at $809, and Lucentis’s ASP was lowest, at $585. However, Sandoz experienced this trend previously with its pegfilgrastim biosimilar Ziextenxo, which stopped reporting ASP pricing for more than a year after a tumultuous reduction in quarterly ASPs. According to the Samsung Bioepis Biosimilar Trend Report, Cimerli’s marketshare had eclipsed that of Lucentis last year, reaching 49% entering the fourth quarter.
When an ASP falls quickly, providers who “buy and bill” are at risk of losing money on their drug purchase. This occurs because they purchase the drug at one price but may not be reimbursed until the next quarterly ASP update is released. If that drug’s ASP is sufficiently below the ASP of the previous quarter (when it was purchased), the insurer will reimburse the physician’s office at the lower amount. Samsung Bioepis reported that the ASPs for the ranibizumab category fell by 9% in the first quarter of 2025 overall compared with the previous quarter, driven mostly by Cimerli’s ASP drop. Cimerli’s ASP in Q2 2025 was listed by CMS as $733.80 for a 0.5-mg injection, a further 10% drop. This compares with $452 for Lucentis (a quarterly reduction of 22%) and $427 for Byooviz (a decrease of 47%). These figures may leave providers without an opportunity to stay above water if using ranibizumab, driving them in the short term to other agents, such as bevacizumab, aflibercept, or other intravitreal injections.
In its press release, Formycon stated, “While license income from global product sales increased year-over-year, the equity result from Bioeq AG declined significantly in the fourth quarter due to ongoing price erosion in the U.S. The current price development has prompted our commercialization partner Sandoz to temporarily suspend marketing activities and reposition [Cimerli] in the US after one year. This temporary marketing pause leads to a non-recurring impairment requirement of €27.3 million, which will be recognized as an impairment loss.”
On its earnings call on March 27, Formycon’s Chief Business Officer, Nicola Mikulcik, emphasized that Formycon was in constant contact with Sandoz on Cimerli’s ASP issue, and that “they know what best to do with the product,” having experienced this before. “With the price at its current level, we cannot give sufficient rebates,” she said. “We have to make the product sustainable in the market.”
(Updated April 2nd: We asked Samsung Bioepis for a comment on these developments, and a spokesperson for the company responded: “Historically, competition from biosimilars has contributed to lowering the ASP of the biologic (both reference product and biosimilars), and ranibizumab has followed this similar trend, with the ASP of the reference biologic, as well as biosimilars, showing a downward trend since the first biosimilar launch in June 2022. Different molecule classes show different rates of price decline, and ranibizumab is one of the classes that demonstrate increasing price concessions.
“With the amounting pricing pressure, it’s important that we address the critical, fundamental issue at stake, which is the “[Biosimilar] Void”: too few originator biologics (10%) facing loss of exclusivity within the next 10 years have any biosimilars in development at all. That needs to change, especially in the US, for a health competitive market place to emerge and fully benefit patients through expanded access and affordability,” said Samsung Bioepis.
Indeed, the rapid decline in ASPs for the ranibizumab class does have implications for future investment in the ophthalmic class and other biologics covered under the medical benefit. Consider aflibercept, which has several competitors launching this year. This does add greater complexity to addressing the biosimilar void.
