Samsung Bioepis ready to enhance reputation with European launch of denosumab biosimilars

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This month, Samsung Bioepis announced the European launch of Obodence (60 mg pre-filled syringe) and Xbryk (120 mg vial), denosumab biosimilars referencing Prolia and Xgeva.

Antonio Rito, vice president and head of Europe at Samsung Bioepis, spoke to The Pharma Letter about the significance of this launch, into what is a very competitive market for denosumab biosimilars.

‘Massive’ impact

Obodence, referencing Prolia, has been approved to treat osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, and for bone loss associated with long-term systemic glucocorticoid therapy in adults at increased risk of fracture. “The impact will be massive, because osteoporosis affects nearly 20% of the global adult population,” he said. “With the increase in skeletal fragility and the fracture risk, the impact of these diseases in terms of quality of life for these patients, is dramatic.”

Xbryk, referencing Xgeva, has been approved for the prevention of skeletal related events in adults with advanced malignancies involving bone, and to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. Bone is one of the most common sites of metastasis across a range of solid cancers, ranging from 30% to 80% depending on the cancer type. Skeletal-related events resulting from bone metastases occur in over 50 % of metastatic cancer patients, and they significantly impact patients’ quality of life, potentially leading to death as well as increasing health care costs. 

Indeed, in Europe alone, osteoporosis results in 4.3 million fragility fractures and health care costs reaching €56 billion ($66 billion) annually. 

“And then there are the limited options for affordable treatment,” Mr Rito said. “We can estimate, without any concern, that more than half of women at high risk of fracture are left untreated. We know that denosumab, for the moment, is not always first-line treatment in Europe. The launch of biosimilars will help the local health authorities to reconsider the guidelines, to give more access.” 

Building on Epysqli success

Samsung Bioepis can draw on its commercialization experience in becoming the market leader in Europe with its Soliris (eculizumab) biosimilar Epysqli, to ensure the successful launch of these new products. Obodence and Xbryk mark the company’s 10th and 11th biosimilars to be launched in Europe and the second and third products to be commercialized directly by Samsung Bioepis.

With Epysqli, the company did not experience any issues in supply continuity, nor receive any complaint letters from the European Medicines Agency.

“In my view, what we have done, and the results we have achieved with Epysqli in Europe are remarkable,” Mr Rito said. “We have relevant experience in partnering with key opinion leaders, renowned prescribers and, most importantly, the scientific society of nephrologists and hematologists, in Europe. We launched Epysqli with a very strong grade of scientific preparation, which has resulted in treatment of more than 650 patient equivalents in Europe. This is a significant number, as eculizumab was considered to have neared the end of its lifecycle with patent expiry.

"However, eculizumab is still actively prescribed as the first-line treatment, as biosimilars are giving flexibility in treatment of acute diseases like aHUS. 

"With this experience, we can leverage the same process. We have the plan to launch denosumab in the same countries where we are present with Epysqli, and to expand the Epysqli footprint while we launch denosumab also in Central and Eastern European markets.” 

Creating savings for wider societal benefit

Indeed, in total, the company plans to enter more than 19 markets encompassing western Europe, the UK and central and eastern Europe.

This will increase the capacity of Samsung Bioepis to deliver further savings for health systems in Europe, having already saved them around $7.3 billion in five European countries over a five-year period (2018-2023) through its on-market biosimilars, primarily in immunology and oncology. 

In delivering these savings for health systems, countries can save their healthcare funds to pay for access to innovative medicines. 

But becoming a biosimilars powerhouse that delivers such savings is not easy. In a region as diverse and fragmented as Europe, developing supply chains and country-by-country relationships takes time and hard work.

“Our mission is really to capitalize on what we are doing already with Epysqli,” Mr Rito said. “That means working on supply chain, because we believe that quality assurance and supply continuity are critical factors in launching a biosimilar in the European market. 

“And every country in Europe has different regulations, different guidelines to follow. So, in this moment, we are really working case-by-case to create this partnership with local authorities to position Samsung Bioepis as a reliable partner.”

Indeed, the company’s decade-long track record underscores its reliability in supplying biosimilars across multiple therapeutic areas, supported by a diversified manufacturing and supply network and backup sites across Europe, North America, South America and Asia. 

In a field where many biosimilars companies are focused on cost containment, Samsung Bioepis’ approach is to continue to invest in the generation of real-world evidence, maintaining close relations with physicians to understand their needs and collecting data that demonstrates how the company’s biosimilar can be considered the product of choice for many patients. 

In doing this, the company is able to treat more people with its products and enhance the reputation that it has with physicians and regulators alike. 

“Our long-term strategy in Europe is very clear. We want to establish Samsung Bioepis as a trusted manufacturer that can partner with health authorities to give more access to medicines for patients, while also generating savings to give opportunities for access to next-generation of novel medicines. Having the right people on the field with strong scientific expertise, building partnership with prescribers backed by robust pre-clinical, clinical and real-world evidence, I believe we are on the right path achieve this goal.”