Samsung Bioepis' Epysqli Approval Sets a New Milestone in Biosimilar Development

The growth of biosimilars has been a significant development in the pharmaceutical industry in recent years. Biosimilars are biological products that are highly similar to reference biologic drugs, with no clinically meaningful differences in terms of safety, efficacy, and quality. This emerging market has experienced substantial growth due to several factors. First, the expiration of patents for many originator biologic drugs has opened up opportunities for the development and approval of biosimilars, leading to increased competition and potentially lower costs for patients. Second, regulatory agencies around the world, including the U.S. FDA and the European Medicines Agency, have established robust frameworks for the approval of biosimilars, providing a clear pathway for manufacturers to bring these products to market. Furthermore, healthcare systems and providers are recognizing the potential cost savings associated with biosimilars, making them an attractive option for increasing access to life-saving treatments. As a result, the biosimilars market is projected to continue its upward trajectory, offering patients more affordable options and driving innovation in the biopharmaceutical industry. According to BioIntel360, global biosimilar market size is expected to record a CAGR of 26.2% during 2023-2027 to reach US$50,727.8 million by 2027, increasing from US$20,021.5 million in 2023. Over the last five years, the sector has recorded a CAGR of 28.0% to reach US$15,734.7 million in 2022.

Samsung Bioepis, a biopharmaceutical company, has achieved a significant milestone in the field of biosimilars with the approval of their eculizumab biosimilar, Epysqli, by the European Commission (EC). This approval signifies not just the first eculizumab biosimilar in Europe but also the first haematology biosimilar in the European Union. Epysqli is prescribed to treat paroxysmal nocturnal hemoglobinuria (PNH), a rare blood condition in which the immune system attacks and harms platelets and red blood cells.The Vice President and Head of the Regulatory Affairs Team at Samsung Bioepis, Byoungin Jung, reaffirmed the firm's commitment to increasing the range of available PNH treatments in Europe.

This approval signifies their dedication to improving the lives of patients, particularly those with rare diseases, through innovative science and technology.
An extensive review of analytical, in vitro, nonclinical, and clinical research served as the foundation for the EC approval. In a phase 3 randomised, double-blind, multicenter, cross-over research, Epysqli was compared to the reference drug Soliris for its safety, effectiveness, pharmacokinetic, pharmacodynamic, and immunogenicity characteristics.The study, which included 50 patients with PNH, demonstrated similar outcomes between the two drugs. A presentation of the analyses' findings was made during the 2022 European Haematology Association Congress.
During the study, patients were randomized to receive either Epysqli or the reference product, with a total of 25 patients in each group. The treatment regimen involved a weekly intravenous dose of the first drug for four weeks, followed by a higher dose in the fifth week. From week 26 onwards, patients were switched to the second drug and received doses every two weeks until week 50.
46 of the 49 patients who were given a study medicine for therapy finished the full 50 weeks. According to the investigation, there was a mean difference in lactate dehydrogenase (LDH) levels between the biosimilar and the reference product at week 26 of 34.48.
Epysqli marks the seventh biosimilar developed by Samsung Bioepis to receive approval in Europe, joining a portfolio that includes biosimilars for etanercept, infliximab, adalimumab, trastuzumab, bevacizumab, and ranibizumab. This accomplishment highlights the company's expertise and dedication to advancing biosimilar therapies in various therapeutic areas.
Bekemv, another eculizumab biosimilar created by Alexion Pharmaceuticals, received a favourable opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in February 2023. Furthermore, in August 2022, Amgen declared the successful conclusion of a phase 3 trial for their eculizumab biosimilar candidate. In PNH patients, this trial verified the candidate and Soliris' biosimilarity.
The approval of Epysqli and the progress made by other pharmaceutical companies in developing eculizumab biosimilars signify a growing interest in biosimilar development. These advancements hold the potential for increased accessibility to important therapies, fostering competition in the market and leading to more affordable treatment options for patients with rare diseases like PNH.

Looking ahead, BioIntel360 suggests that the future of biosimilars appears promising. As more biosimilars gain approval and enter the market, patients will benefit from a broader range of treatment options. The availability of cost-effective alternatives to reference biologics will not only alleviate the financial burden on healthcare systems but also enable physicians to provide optimal care for their patients.