Pharma maker develops biosimilars to Lucentis, Eyelea.
Biosimilar drugs currently under development are expected to profit in the lucrative retinal diseases market.
Samsung Bioepis Co. recently entered into a commercialization agreement with Biogen for the biosimilar versions of ranibizumab (Lucentis, Novartis) and aflibercept (Eylea, Regeneron Pharmaceuticals), which treat macular degeneration, diabetic retinopathy, and other eye diseases.
The commercialization agreement is for Samsung Bioepsis’s SB11 (ranibizumab) and SB15 (aflibercept) in the United States (US), Canada, Europe, Japan, and Australia. Under the agreement, Samsung Bioepis will receive upfront payments of $100 million, up to $270 million in milestone/option payments, as well as sharing of sales revenue.
The biosimilar drugs under development will enter a lucrative market. In 2018, global healthcare expenditures for Lucentis and Eylea were nearly $11 billion combined, and more than $5.8 billion was spent in the US alone, according to a prepared statement for FormularyWatch ® from Samsung Bioepsis .
“Retinal diseases including wet AMD (age-related macular degeneration), RVO (retinal vein occlusion), and DME (diabetic macular edema) are the leading cause of blindness in the US and in multiple countries across the world,” the statement read. “We believe biosimilars will play an important role in expanding access to these important ophthalmological medicines, enabling earlier access to treatment before disease is progressed irreparably.”
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Since SB11 is undergoing a phase 3 clinical trial and SB15 is in pre-clinical development, Samsung Bioepsis is unable to provide the timeline for the US launch of SB11 and SB15 or the wholesale acquisition cost of the 2 medications, the spokesperson said.
The FDA has approved 8 biosimilars so far in 2019. “While biosimilars still represent a small portion of the US biologics market, at this current stage, the biosimilar market is expected to grow nearly three-fold by 2023 and support significant cost savings to the US healthcare systems,” according to the statement. Over the next 5 years, the US could save up to $160 billion in healthcare costs from biosimilars, he added.