Biogen, Samsung Report Third-Quarter Biosimilar Results

Cambridge, Massachusetts–based Biogen reported biosimilar revenues up 13% for the third quarter of 2020, to $208 million. Biogen markets etanercept (Benepali), adalimumab (Imraldi), and infliximab (Flixabi) biosimilars. Benepali revenues were up 7%, or $124 million vs 116 million in the year-ago third quarter; Imraldi, up 14%, or $56 million vs $49 million; and Flixabi, up 49%, or $27 million vs $18 million.

Etanercept, adalimumab, and infliximab are used in the treatment of autoimmune diseases such as Crohn disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, and psoriatic arthritis.

In total, the company reported third-quarter revenues of $3.4 billion, down 6%.

In October, Biogen and Samsung Bioepis reported that the European Medicines Agency had accepted their application for approval of a proposed ranibizumab biosimilar (SB11), referencing Lucentis. Ranibizumab is an anti–vascular endothelial growth factor agent indicated for the control of blood vessel proliferation in retinal vascular disease.

Samsung Biologics, a major owner of the biosimilars company Samsung Bioepis, reported a third quarter 2020 operating profit of $50 million on revenues of $241.8 million. The company said sales were up 49% over the comparable 2019 quarter despite a global slowdown caused by the coronavirus disease 2019 pandemic.

In August, Samsung Bioepis’ bevacizuamb biosimilar (Aybintio) was granted marketing approval by the European Commission. The drug was indicated for the treatment of metastatic colorectal cancer; breast cancer; non–small cell lung cancer; renal cell carcinoma; epithelial ovarian, fallopian tube, and primary peritoneal cancer; and cervical cancer.

During the third quarter, the Incheon, Republic of Korea–based Samsung Biologics announced plans to construct what it called the world’s largest biologics factory, spanning 23.8 million feet. Manufacturing activities are scheduled to begin in the second half of 2022. The company's current 3 manufacturing plants are approaching capacity and in combined floor space do not equal the anticipated size of the new plant.