Ranibizumab Biosimilar Updates: A Nascent Market but Limited Competition

Ranibizumab (Lucentis®) was the first opportunity for biosimilar manufacturers in the lucrative ophthalmology market. Not withstanding the potential launches of biosimilars for market-leader aflibercept (Eylea®), which holds the greatest marketshare, and the performance of other biobetters or brands (Vabysmo®, Susvimo®), some early ranibizumab biosimilar uptake is occurring. However, a third competitor, which may be crucial for lowering net prices more quickly, seems unlikely before this time next year.  

Coherus Biosciences reported its second-quarter earnings, which focused heavily on the early performance of its biosimilar Cimerli®. The company believes that Cimerli will ring up $100 million in net revenues by end of 2023, based on $26.7 million of business for the second quarter.

Cimerli was designated by the FDA as interchangeable with Lucentis, but this is primarily a buy-and-bill medication with very limited specialty pharmacy distribution. Therefore, an interchangeable designation may not have significant impact on utilization.

According to Samsung Bioepis’ Biosimilar Market Report (which includes data from the first quarter of 2023), market shares of Cimerli and Samsung’s own biosimilar product Byooviz® were 4% apiece (this was up from a negligible share for Cimerli in the fourth quarter of 2022 and static for Byooviz at 4% in that quarter). The new competition has resulted in an 11% reduction in average sales price for all ranibizumab products since the initial biosimilar launch of Byooviz in the third quarter of 2022.

With only the two biosimilars currently launched, the net costs for this category may decline at or slightly below the historical average of 12% to 15% annual reductions seen across other biosimilars covered under the medical benefit. It may take the entrance of a third competitor to yield greater savings.

What of the third competitor? XBrane Biopharma announced on July 24 that it is now seeking a new partner for commercializing its biosimilar candidate Xlucane™ in the US. An agreement with Bausch + Lomb to market the agent was discontinued “by mutual consent.” XBrane and partner STADA Arzneimittel withdrew its initial 351(k) application for the investigational biosimilar in Q2 2022. They announced that a new biologic license application was filed in June 2023, with a BsUFA action date of April 21, 2024. Finding a new marketing partner experienced in the ophthalmology space may slow the introduction of this biosimilar, should XBrane gain FDA approval.

Lupin had estimated completion of its phase 3 trial for LUBT010 for October 2022, but no updates have been released on the results. Reliance Life Sciences was reported to have an investigational biosimilar in phase 3 trials, but this could not be confirmed through the company or through ClinicalTrials.gov. In other words, that third competitor will not arrive soon.

In Related Biosimilar News

Coherus also reported in its second-quarter earnings release that Udenyca® net revenues increased 21% in the second quarter compared with the first quarter of 2023 ($32 million vs. $26 million, respectively). This increase was driven by greater utilization, according to the company; marketshare of this pegfilgrastim biosimilar was 12.2%, which is higher than for the prior quarter, but well below the 20% uptake at its peak.

They hope their autoinjector introduction in June will help make inroads into this fierce competition, and it still plans to introduce its on-body injector to compete with Neulasta® OnPro®. before end of year. OnPro retains 42% of the market.

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