Bevacizumab

As AbbVie continues to fend off competition for Humira (adalimumab) and hold onto a dominant market position, a new report from Samsung Bioepis suggests that the immunology space in particular may be unfavourable to biosimilars, which tend to have quicker adoption in oncology and ophthalmology. Despite facing more competitors than any other biologic, the anti-TNF-α antibody had managed to retain 82% of its market share as of this May — though that figure is a sharp drop from just two months earlier in the year, when Humira held a 95% pole position. For related analysis, see Physician Views Results: Lack of financial incentive and prescriber confidence stalling adoption of biosimilar Humira products.That rapid market share erosion is, in part, due to CVS Caremark’s January decision to replace Humira with biosimilar versions of the antibody, the first major pharmacy benefit manager (PBM) to do so. In April, shortly after Humira was dropped from CVS’s formularies in favour of Sandoz’s Hyrimoz, the biosimilar saw an “explosion” in new prescriptions. According to Samsung’s report, Hyrimoz accounts for about 10% of sales now, while the rest of the adalimumab biosimilars have only managed to accrue a percentage or two. Looking to replicate Sandoz’s success is Boehringer Ingelheim, which in May inked a deal to manufacture its interchangeable biosimilar Cyltezo for Quallent Pharmaceuticals, a private-label pharmaceutical distributor owned by Cigna. The tie-up came shortly after the German drugmaker announced an overhaul of its sales team for the biosimilar following lower-than-expected uptake. For related analysis, see FDA refreshes biosimilar action plan, but uptake may be in hands of payers like Cigna.Disease divisionSamsung’s report divided the biosimilars marketed in the US into two buckets: those with fast uptake who achieved an average market share of 75% within three years of launching; and those who’ve had slow uptake, reaching an average of just 23% of the market after three years. Biosimilars of three oncology drugs Rituxan (rituximab), Avastin (bevacizumab), and Herceptin (trastuzumab) were all classified as rapid growers. Cimerli, a biosimilar of ophthalmology antibody Lucentis (ranibizumab), is also trending towards fast uptake; since its launch in October 2022, it’s claimed about 44% of sales.  On the other end of the spectrum, competitors of autoimmune disease therapy Remicade (infliximab), chronic kidney disease treatment Epogen (epoetin alfa), and Sanofi’s insulin glargine products have had much slower encroachment. While Humira biosimilars have only been on the market for a year and a half, AbbVie’s market share retention thus far suggests its pool of 10 competitors will most likely end up in the slow bucket.However, Samsung does note that biosimilar adoption has evolved as the market matures, pointing out that Remicade biosimilars, despite their slow start, now hold nearly half of the market share.

Roche’s Susvimo was first approved by the US Food and Drug Administration (FDA) to treat wet AMD in 2021. Image Credit: Michael Derrer Fuchs / Shutterstock. Two years following a voluntary recall, Roche has relaunched Susvimo (ranibizumab injection) for use as an ocular implant for the treatment of wet age-related macular degeneration (AMD). The company has updated the components of the ocular implant and refill needle, whose inadequate performance resulted in septum dislodgement, which was the reason behind the recall. The 2022 recall was informed by a US study that showed that “some implants did not perform to Roche’s standards”, as per the company. Susvimo consists of a customised formulation of ranibizumab, which is also co-marketed by Novartis and Roche as Lucentis . The eye implant is meant to be inserted in a one-time outpatient procedure. The device is refilled every six months using a specialised needle. Susvimo was first approved by the US Food and Drug Administration (FDA) in 2021. Roche also plans to develop Susvimo for other eye disorders, including diabetic macular oedema. Roche is a market leader in the wet AMD treatment space, with two marketed therapies, Lucentis and Vabysmo (faricimab) . Lucentis and Vabysmo pulled in SFr460m ($512m) and SFr2.4bn ($2.6bn) in sales last year, as per Roche’s financials. See Also: BARDA and Tiba Biotech link to develop ‘flu therapeutics Merz wins $185m bid for bankrupt Acorda assets and increases US workforce by 50% Whilst Lucentis sales are expected to drop in the coming years, with estimates for the therapy of under $372m in 2030, Vabysmo sales are expected to soar to over $8.5bn in 2030, as per GlobalData analysis. GlobalData is the parent company of Pharmaceutical Technology . Roche and Chugai Pharmaceutical’s Avastin (bevacizumab) is also used as an off-label therapy for wet AMD. Outlook Therapeutics is currently working to develop a branded version ofbevacizumab. In August 2023, the US FDA rejected a biologic licence application (BLA) for the company’s bevacizumab-vikg candidate. The US agency noted several manufacturing issues and the need for additional confirmatory clinical data. Another company developing an implant for wet AMD is Ocular Therapeutics. In October 2023, the company launched a trial to evaluate the implant against Regeneron Pharmaceuticals and Bayer ’s Eylea (aflibercept) . Other therapies in development for treating wet AMD include a gene therapy by China-based Skyline Therapeutics, a biodegradable insert containing a tyrosine kinase inhibitor by EyePoint Pharmaceuticals , and an anti-VEGF transgene therapy by 4D Molecular Therapeutics .