Earnings fell overall for Biogen, although biosimilar revenues continued an upward climb.
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.
Data Show Promise for Adalimumab Biosimilars to Deliver on Safety, Cost Savings
May 16th 2024Two posters from the Academy of Managed Care Pharmacy’s annual meeting provided hope that despite low uptake so far, adalimumab biosimilars can deliver on the promise of comparable safety and efficacy with the originator in multiple disease states, as well as cost savings.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Partnering for Biosimilar Security: India's Role in US Health Care Savings, Supply Chain Stability
May 9th 2024As Indian pharmaceutical companies supplied 4 of every 10 prescriptions in the US in 2022, generating $1.3 trillion in health care savings, a new IQVIA report highlights concerns about supply chain risks and advocates for partnerships to bolster biosimilar security and overall supply chain resilience.
Biosimilars Rheumatology Roundup for February 2024—Podcast Edition
March 3rd 2024On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.
Review: Product Attributes Relevant to Injection-Site Pain, Adalimumab Treatment
May 4th 2024A review article summarizes the product attributes of reference and biosimilar adalimumab products, such as formulation with or without citrate, delivery volume, and needle gauge, relevant to patients’ experience of injection-site pain.