Adalimumab-BWWD (Samsung Bioepis)

Spherix Global Insights looked at which biosimilar brands stand to benefit as AbbVie loses access. Spherix Global Insights has provided a different angle on AbbVie’s successful retention of Humira sales in the face of biosimilar competition, polling doctors about forces shaping the market and their preferred off-patent options.AbbVie reported global Humira sales of $2.8 billion in the second quarter. That represented a 29% drop on an operational basis but meant Humira remained a major product more than one year on from the launch of the first biosimilar in the U.S. Spherix surveyed 313 physicians, split roughly evenly between gastroenterologists, rheumatologists and dermatologists, to understand what is happening.Significantly more gastroenterologists than rheumatologists or dermatologists expressed favorable views of biosimilars, Spherix said. Nearly half of gastroenterologists proactively choose to prescribe biosimilar brands, the survey found, but rheumatologists and dermatologists have largely been driven to off-patent options by “external pressures.” Those pressures have intensified slower than some people expected.One rheumatologist said two years ago they would have predicted Humira would only account for 10% of the market by late 2024. Yet, at the time of the survey in April, the rheumatologist wasn’t seeing that split nor encountering any issues when prescribing Humira. Another physician said they felt about 30% of patients were on biosimilars, with the rest staying on Humira. The second physician also expected biosimilars to penetrate the market faster and to face “this whole tsunami of just lots and lots of work and just the sudden shift.” Yet, so far, the shift has “been odd,” the physician said in April, because “it's not every payer and it hasn't been as awful as I thought it would be.”AbbVie expects to “maintain parity access to biosimilars for a significant majority of patient lives this year,” Jeffrey Stewart, the company’s chief commercial officer, said on an earnings call in July. Asked by an analyst about 2025, Stewart said Humira access “will certainly be lower than this year,” but AbbVie expects to maintain parity access for a “meaningful” portion of patients across all channels.Spherix looked at which biosimilar brands stand to benefit as AbbVie loses access. Gastroenterologists still favor Amgen’s Amjevita, the first Humira biosimilar to launch in the U.S., but are gradually increasing their use of unbranded adalimumab, as sold by Sandoz, Boehringer Ingelheim and Biocon, and Samsung Bioepis and Organon’s Hadlima. Physicians in the other specialties are increasingly using Hadlima, too.Specific biosimilar brand usage depends on what is covered by the patient’s insurance. As well as fighting among themselves, biosimilar manufacturers face competition from AbbVie’s Humira successors Skyrizi and Rinvoq. Stewart said AbbVie saw around 20% of patients move to drugs with other mechanisms, such as Skyrizi and Rinvoq, when they lost access to Humira. 

INCHEON, South Korea and CAMBRIDGE, MA, USA I September 20, 2024 I Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for OPUVIZ™ 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea 2 (aflibercept), also known as SB15. OPUVIZ has been recommended for approval in adult patients for the treatment of neovascular (wet) age related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), visual impairment due to diabetic macular oedema (DME), and visual impairment due to myopic choroidal neovascularisation (myopic CNV). “We are pleased to have our second ophthalmology biosimilar OPUVIZ recommended for approval in Europe. This marks another significant milestone for Samsung Bioepis and more importantly for people living with retinal disorders as we are making a step forward in enhancing the availability of the essential treatment,” said Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. “The positive opinion underscores not only our commitment to innovation but also ensuring access so that more patients can benefit from biologic therapies. We will continue our work to transform the way biologic therapies are brought to patients and enhance the lives of patients, through our pioneering and innovative use of science and technology,” she added. “We are excited about the positive CHMP recommendation for OPUVIZ in Europe and the potential for it to serve as a meaningful therapeutic option for individuals impacted by retinal vascular disorders,” said Ian Henshaw, Global Head of Biosimilars at Biogen. “Biosimilars could help broaden access and offer significant healthcare savings through the treatment of these complex and often debilitating ophthalmic diseases.” The CHMP’s positive opinion was based on a totality of evidence including analytical, non-clinical data, and clinical data. A randomized, double-masked, parallel group, multicenter Phase 3 study demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics (PK) profiles between SB15 and reference aflibercept (AFL). The primary endpoint was met in terms of change from baseline in best corrected visual acuity (BCVA) at week 8, and the 32-week interim analysis and 56-week analysis demonstrated comparability in other secondary efficacy, safety, immunogenicity, and PK endpoints between SB15 and AFL. 3, 4 This CHMP’s positive opinion will now be referred to the European Commission (EC) which will decide whether to grant a marketing authorization for OPUVIZ. If a marketing authorization is granted by the EC, OPUVIZ would become the second ophthalmology biosimilar approved in Europe and fifth biosimilar in the portfolio developed by Samsung Bioepis with commercialization rights held by Biogen, which includes BYOOVIZ™ (ranibizumab), BENEPALI™ (etanercept), IMRALDI™ (adalimumab) and FLIXABI™ (infliximab). In November 2019, Samsung Bioepis and Biogen announced that they had entered into a commercialization agreement for two ophthalmology biosimilar candidates, BYOOVIZ (SB11, ranibizumab) and OPUVIZ (SB15, aflibercept), in the U.S., Canada, Europe, Japan and Australia. About the SB15 Phase 3 study 3 The study is a randomized, double-masked, parallel group phase 3 study conducted at 56 centers in 10 countries from June 2020 to March 2022, including follow-up through 56 weeks. Of 549 screened participants, 449 participants 50 years and older with treatment-naive nAMD were randomized 1:1 to receive either SB15 (n = 224) or AFL (n = 225). At Week 32, patients were re-randomized to either continue SB15 or AFL, or switch from AFL to SB15 resulting in three treatment groups; continuing SB15 (SB15/SB15, n=219), continuing AFL (AFL/AFL, n=108), switching from AFL to SB15 (AFL/SB15, n=111). In total, 425 patients completed up to Week 56. Key efficacy endpoints of the study were 1) change from baseline in best corrected visual acuity (BCVA), 2) change from baseline in central subfield thickness (CST), and 3) proportion of patients with intra or sub-retinal fluid. About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X , LinkedIn . About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. We routinely post information that may be important to investors on our website at www.biogen.com . Follow us on social media – Facebook , LinkedIn , X , YouTube . SOURCE: Samsung Bioepis