Russian drug manufacturer Generium Pharmaceutical, which specializes in orphan drugs, announced yesterday that it has received Russian marketing approval for its biosimilar eculizumab, referencing Soliris, the most expensive orphan drug in Russia.
Russian drug manufacturer Generium Pharmaceutical, which specializes in orphan drugs, announced yesterday that it has received Russian marketing approval for its biosimilar eculizumab, referencing Soliris, the most expensive orphan drug in Russia.
The biosimilar was authorized for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), which is a rare and life-threatening disease of the blood characterized by destruction of red blood cells by the complement system, and atypical hemolytic uremic syndrome (aHUS), which is an extremely rare, life-threatening, and progressive condition caused by the uncontrolled activation of the complement system.
“The joint efforts of Russian, US, and Swiss scientists have made it possible to achieve significant progress in the development of high-tech medicines for the treatment of rare diseases such as a PNH and aHUS, with the economic benefits of local production,” Dmitriy Kudlay, chief executive officer of Generium, said in a statement announcing the product’s approval.
While Generium is the first to gain approval for its biosimilar, it is by no means the only Russian drug developer with an interest in eculizumab; Biocad recently announced that it has begun clinical studies for its own biosimilar eculizumab candidate referencing Soliris.
Biocon’s study of the eculizumab biosimilar in patients with PNH, marking a foray into ultrarare diseases, is a new direction for the Russian biosimilar developer; thus far, Biocad has focused on the development of more widely used biosimilars, such as filgrastim, bevacizumab, trastuzumab, infliximab, and adalimumab.
Increasingly, developers see ultrarare diseases as viable markets for their biosimilars, due in part to the fact that patients with rare diseases are taking even the highest-priced drugs at increasing volumes; Alexion, which makes the reference eculizumab product, recently revealed that its sales volume for the ultra—high-cost drug had increased by 24% in 2018 versus 2017, driven in part by its recently granted indication for the treatment of the rare disease myasthenia gravis. Alexion is also seeking another new indication for the innovator product in another rare disease, anti-aquaporin-4 auto antibody-positive neuromyelitis optica spectrum disorder.
What Stands in the Way of Biosimilar Use Across MENA Countries?
May 21st 2025Despite the clear promise of cost savings and expanded access, the path to integrating generics and biosimilars across the Middle East and North Africa (MENA) region is tangled in a web of distrust, inconsistent policies, and deep-rooted cultural preferences for branded drugs.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
The Trump Administration’s Drug Price Actions and Why US Prices Are Already Sky-High
May 17th 2025While the Trump administration’s latest executive order touts sweeping drug price cuts through international benchmarking, the broader pharmaceutical pricing crisis in the US reveals a far more complex web of development costs, profit incentives, and absent price controls—raising the question of whether any single policy, including potential drug tariffs, can truly untangle it.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Samsung Bioepis Report Signals Turning Point for US Biosimilars
May 1st 2025A wave of biosimilar approvals, aggressive pricing strategies, and a regulatory sea change are setting the stage for unprecedented momentum in the US biologics market, with 2025 already proving to be a landmark year in reshaping cost, access, and innovation across therapeutic areas.