Adalimumab-ADBM( Boehringer)

Cigna's Express Scripts is following CVS Caremark in excluding branded Humira from its formularies. When CVS Caremark removed AbbVie’s Humira from its national commercial formularies back in April, biosimilar prescriptions picked up at a whirlwind pace. Now, Cigna’s Express Scripts is following suit in a move that could further chip away at Humira’s market share.Express Scripts, which is Cigna’s pharmacy benefit unit, is removing branded Humira from its largest commercial formularies come 2025 in favor of biosimilar options from Teva, Sandoz and Boehringer Ingelheim.“We’ve been thoughtful in developing a comprehensive approach that considers not just the formulary placement of biosimilars, but also each product’s clinical efficacy, interchangeability, available supply, dose, and concentration that will provide a seamless patient experience with these more affordable products,” Express Scripts President Adam Kautzner said in a release, adding that the company is “prepared to embrace the savings biosimilars offer."AbbVie did not immediately respond to Fierce Pharma’s request for comment. Express Scripts first added Boehringer Ingelheim’s Humira copycat Cyltezo and Sandoz’s Hyrimoz—plus Sandoz’s unbranded biosim—as preferred products to its National Preferred Formulary last July. The company’s parent group Evernorth, which is also owned by Cigna, previously estimated that biosimilar competition can save the U.S. up to $375 billion in total pharmacy spending over the decade.While the onslaught of biosimilar competition has led to a sizable decline in AbbVie’s Humira sales, the originator's remaining 82% market share shows that supplanting the entrenched product won't be easy for the biosimilar marketers. In September, a Spherix Global Insights analysis revealed that prescribers had not yet “wholly warmed to these newcomers,” with dermatologists in particular showing the “highest degree of stated resistance to change.” As it stands, Sandoz’s Hyrimoz has been responsible for “most biosimilar gains," scoring about four-fifths of Humira biosimilar prescriptions through April 25, a Samsung Bioepis report found. On the flip side, a rough launch for Boehringer Ingelheim’s Cyltezo prompted layoffs in its customer-facing Cyltezo teams in a pivot to a hybrid in-person and virtual sales model.Meanwhile, at AbbVie, the company’s strategy to weather the impact of the Humira sales erosion with successors Rinvoq and Skyrizi is panning out as planned. Its recent quarterly Humira sales plunge of 29.8% was once again balanced out by double-digit growth for the two newer drugs, with Skyrizi steadily creeping up on Humira's level of sales. 

The biosimilar references Regeneron and Bayer’s blockbuster ophthalmology asset Eylea (aflibercept). Image credit: Shutterstock / photoJS. The US Food and Drug Administration (FDA) has approved Sandoz ’s Enzeevu (aflibercept-abzv), the drugmaker’s biosimilar for wet age-related macular degeneration (AMD). Available as a 2mg vial kit and pre-filled syringe, the biosimilar– which references Regeneron and Bayer ’s Eylea (aflibercept) – is indicated to improve and maintain visual acuity in patients with the eye disease. Enzeevu joins Biocon Biologics’s Yesafili (aflibercept-jbvf) and Samsung Bioepis’ Opuviz (aflibercept-yszy) in the list of FDA-approved biosimilars to Eylea. Yesafili and Opuviz were both greenlit by the agency as the first biosimilars in May this year. They were both designated as interchangeable products. The FDA has provisionally said Enzeevu would be interchangeable with Eylea as “it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products”, as per a 12 August press release. Interchangeable biosimilars are eligible for a year of market exclusivity if they are the first biosimilar of a given product to receive interchangeable designation, as per the Biologics Price Competition and Innovation Act. It is possible that multiple interchangeable biosimilars could share a period of initial exclusivity if they are approved at the same time. See Also: What’s involved in designing effective lyophilization cycles? Sanofi invests $1.4bn in insulin production in Germany However, how this exclusivity period is exercised was scrutinised when Boehringer Ingelheim , which produces the first interchangeable biosimilar for Humira (adalimumab) called Cyletzo, was in litigation with Pfizer , which also produces an interchangeable biosimilar. The company has said that Enzeevu’s launch will be dependent on the outcome of pending or potential future related litigations, as well as any potential settlements, amongst other factors. Sandoz did not reply to a request from Pharmaceutical Technology to clarify the exclusivity timelines. Biosimilars are not new to the wet AMD treatment space, with the first copycat to Genentech’s Lucentis (ranibizumab) hitting the market in 2021. Sandoz strengthened its ophthalmology portfolio when it spent $170m to acquire Cimerli (ranibizumab-eqrn) – the first interchangeable biosimilar to Lucentis – from Coherus in March this year. Sandoz stated Enzeevu will be a “key biosimilar value driver” as the company expands its ophthalmology presence. Sandoz, which completed its spin-off from Novartis late last year, lifted its 2024 sales guidance earlier this week while reporting Q2 financial results. Propelled by strong sales of the Humira-copycat Hyrimoz, the company notched total sales of $2.6bn for the second quarter. Wet AMD, also known as neovascular AMD, is a leading cause of vision loss, affecting around 1.5 million people aged 40 years and older in the US. Amongst AMD cases, the wet subtype is responsible for 90% of severe vision losses. Similar to Eylea, the biosimilars work by inhibiting vascular endothelial growth factor (VEGF), which prevents abnormal blood vessel growth. Regeneron’s Eylea currently dominates the ophthalmology market, netting $5.89bn in sales last year. However, product revenues were down by 6.3% from the year before due to increased competition from Roche’s wet AMD drug Vabysmo (faricimab) and others. Regeneron has also been locked in various court battles with other companies over alleged patent infringements with their aflibercept biosimilars. Samsung Bioepis’ Opuviz received a preliminary injunction, whilst Biocon was hit with a permanent injunction. Regeneron won a case against Viatris ’s proposed biosimilar in December 2023, citing a patent that protects its drug until 2027. Along with biosimilar introduction, Eylea will also face competition from Vabysmo. Vabysmo, whose patent expires in 2039, reached blockbuster status in only its second year on the market, notching $2.66bn in global sales last year. The biologic is predicted to see revenues of $8.5bn by 2030, according to GlobalData’s Pharma Intelligence Center. GlobalData is the parent company of Pharmaceutical Technology .