Biocon Biologics settled with the maker of Eylea (aflibercept), announcing a launch date for its biosimilar competitor in Canada; Sandoz has officially acquired Cimerli, a ranibizumab biosimilar; AARP Medicare Rx from United Healthcare has added Cyltezo (adalimumab-adbm) and removed the originator (Humira) from its formulary.
Biocon Biologics reached a settlement with the maker of Eylea (aflibercept), announcing a launch date for its biosimilar competitor in Canada; Sandoz has officially acquired Cimerli, a ranibizumab biosimilar; AARP Medicare Rx from United Healthcare has added Cyltezo (adalimumab-adbm) and removed the originator (Humira) from its formulary.
Aflibercept Settlement in Canada
Biocon Biologics settled with Bayer and Regeneron Pharmaceuticals regarding its aflibercept biosimilar candidate (Yesafili), allowing it to launch in Canada no sooner than July 1, 2025, according to a report from Business Standard.
Yesafili received tentative approval from Health Canada in March 2023. Yesafili is used to treat various eye diseases, including neovascular age-related macular degeneration, central retinal vein occlusion, branch retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization.
This settlement followed patent infringement proceedings in Canada. Biocon Biologics has been expanding its biosimilar portfolio globally, with Yesafili already receiving marketing authorization in the United Kingdom and the European Union in November and September 2023, respectively.
Sandoz Acquires Ranibizumab Biosimilar
Sandoz announced that it has completed the acquisition of Cimerli (ranibizumab-eqrn), a biosimilar referencing Lucentis (ranibizumab), from Coherus Biosciences.
The biosimilar was approved in August 2022 and launched on the US market in October 2022. Cimerli was also one of the first biosimilars to receive an interchangeability designation. Ranibizumab products are vascular endothelial growth factor inhibitors used to treat neovascular age-related macular degeneration, diabetic retinopathy, and macular edema.
The acquisition included a biologics license application, product inventory, ophthalmology sales and field reimbursement talent, and access to proprietary commercial software. Sandoz disclosed that it paid $170 million in upfront payments.
“Today we further expand the Sandoz biosimilar portfolio, while advancing our mission in the U.S. of pioneering patient access to more affordable and much-needed medicines,” Keren Haruvi, president of Sandoz North America, said in the release. “With the addition of Cimerli to our existing ophthalmology franchise, we can now offer even more treatment options for U.S. patients with vision impairment and loss.”
Trend of Payers Choosing Adalimumab Biosimilars Over Humira Continues
AARP Medicare Rx from United Healthcare has chosen to add Cyltezo, an interchangeable adalimumab biosimilar, to its formulary in place of Humira, the originator. Cyltezo is also the only adalimumab biosimilar on the list.
Adalimumab products are used to treat a number of inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, Crohn disease, hidradenitis suppurativa, ankylosing spondylitis, uveitis, and juvenile idiopathic arthritis.
The news comes after CVS Health announced that it would remove Humira from some of its reimbursement lists in favor of Cyltezo and Abrilada (adalimumab-afzb). Additionally, the Mark Cuban Cost Plus Drug Company, an online pharmacy dedicated to improving access to lower-cost generics, chose Coherus Biosciences’ Yusimry (adalimumab-aqvh) as the only adalimumab biosimilar and first biologic to offer to its customers.
Spanish Real-World Study: Adalimumab Biosimilar MSB11022 Safe, Effective in IBD
May 18th 2024A real-world study in Spain on inflammatory bowel disease (IBD) patients found no meaningful changes in clinical or biochemical markers or differences in effectiveness between the adalimumab originator and the biosimilar MSB11022 (Idacio; Fresenius Kabi) in adalimumab-naïve patients.
Panelists Call for Consistent Education, Support to Improve Patient Comfort With Biosimilars
May 15th 2024At the Festival of Biologics USA, panelists stressed the need for patient-centered communication and education to boost comfort with biosimilars, emphasizing consistent support from health care providers despite restrictive payer policies.
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.
Cordavis Report Outlines Strategies for Biosimilar Development, Access in the US Health Care Market
May 8th 2024Cordavis, a CVS Healthspire company, released a report detailing the current hurdles faced in developing and commercializing biosimilars in the US and highlighting efforts by the organization to enhance access and affordability for these products.