March 14th 2024
In its earnings report for the fourth quarter and full year of 2023, Coherus Biosciences detailed its rising revenue growth, which it partly attributed to increased sales for its pegfilgrastim and ranibizumab biosimilars.
Discussions on Recent Data and Best Practices for Managed Care in the Treatment of nAMD and DME
1.5 Credits / Ophthalmology/Optometry
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Addressing Unmet Needs and Treatment Gaps in the Clinical Management of Neovascular Age-Related Macular Degeneration: Practical Strategies for Pharmacists in Specialty and Man...
1.5 Credits / Ophthalmology/Optometry
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Management of Neuromyelitis Optica Spectrum Disorder: Expert Insights and Updates for Pharmacists, featuring a Patient Perspective
1.5 Credits / Ophthalmology/Optometry
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The Promising Role of Novel Targeted Therapies in Addressing Clinical and Economic Burdens in Diabetic Macular Edema
1.5 Credits / Ophthalmology/Optometry
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Improving Outcomes and Quality of Care in Age-Related Macular Degeneration and Diabetic Macular Edema: Patient-Centered Strategies in Managed Care
3.0 Credits / Ophthalmology/Optometry
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Maximizing Patient Outcomes in Ophthalmologic Diseases: How Managed Care Professionals Play a Key Role in Facilitating Uptake of Biosimilars
1.0 Credit / Ophthalmology/Optometry
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Eye on Pharma: Eylea Biosimilar Violation; New FDA Labeling Guidance; Alvotech Reinspection
January 25th 2024A Korean health agency issued Samsung Bioepis an administrative penalty related to its biosimilar referencing Eylea (aflibercept); the FDA updates its labeling recommendations for interchangeable biosimilars; Alvotech receives another Form 483 after the FDA reinspected its Iceland-based manufacturing facility.
Report: Varied Biosimilar Uptake Speeds Pose Missed Opportunities for Cost Savings
January 23rd 2024Samsung Bioepis’ Biosimilar Market Report for the first quarter of 2024 chronicles some major market trends, including which treatment spaces have quicker uptake than others, highlighting missed opportunities for savings as well as the 1-year experience of adalimumab biosimilar competition in the US.
IQVIA Projects $192 Billion Loss for Originators by 2028 Thanks to Biosimilar, Generic Competition
January 18th 2024The IQVIA Institute for Human Data Science’s most recent Global Use of Medicines report projected that market introductions of new biosimilar and generic drugs will increase projected losses for originator products from $111 billion to $192 billion over the next 5 years.
Eye on Pharma: Fresh Biosimilar Lawsuits; FDA to Review Ustekinumab, Denosumab Biosimilars
January 11th 2024As Regeneron gears up for a legal battle with biosimilar competitors for its reference aflibercept, CareFirst files a lawsuit against Johnson & Johnson for restricting biosimilar ustekinumab competition; Celltrion and Accord BioPharma file with the FDA to approve their respective biosimilar candidates.
Eye on Pharma: Bevacizumab Update; Samsung Bioepis, J&J Settlement; Another EU Trastuzumab
December 6th 2023Outlook Therapeutics provides an update on the development of its bevacizumab candidate for age-related macular degeneration; Samsung Bioepis settles with Johnson & Johnson (J&J) over its ustekinumab biosimilar candidate; and the European Union gains another trastuzumab biosimilar.
IQVIA Highlights Opportunity to Cash In on Biosimilars for Biologics Losing Market Exclusivity
November 29th 2023A report from IQVIA noted that Europe could miss out on €15 billion in cost savings by not having biosimilars for medications about to lose market exclusivity, shedding light on the implications for overall health care savings and ultimately, patient access.
Eye on Pharma: Adalimumab Updates; New Eylea Biosimilar Lawsuit; Canada Gains Stelara Biosimilar
November 22nd 2023Several companies make moves to further their adalimumab biosimilars, Regeneron sues Celltrion over biosimilar for Eylea (aflibercept), and Health Canada grants marketing authorization for biosimilar referencing Stelara (ustekinumab).
Eye on Pharma: New GI Data and Byooviz Interchangeability Propel Biosimilars Into the Future
October 25th 2023As Celltrion releases new data on its subcutaneous infliximab product in gastroenterology conditions, Samsung Bioepis secures an interchangeability designation for Byooviz, making it the second ranibizumab biosimilar to be deemed interchangeable with the reference product.
Report: Conflicting Guidelines, Rebate Walls Are Major Factors Determining Biosimilar Uptake
October 24th 2023Samsung Bioepis’ most recent biosimilar market report identified inconsistent medical guidelines, challenges with access and rebates, and acute vs chronic treatment duration as major factors influencing biosimilar uptake in the United States.
Eye on Pharma: Another CRL for Alvotech; Cimerli’s Growing Market Share; BBCIC Awarded Grant
October 19th 2023Alvotech received a complete response letter (CRL) for its ustekinumab biosimilar; Formycon’s Cimerli, a ranibizumab biosimilar, achieved 25% market share in the United States; and the FDA awarded a researach grant to the Biologics & Biosimilars Collective Intelligence Consortium (BBCIC).
Higher-Cost Therapies for ARMD Could Contribute to Heightened Medicare Costs; Biosimilars Could Help
September 24th 2023Drug maker payments to ophthalmologists were associated with the choice of higher-cost therapies for age-related macular degeneration (ARMD) that could increase Medicare costs, but biosimilars could help.
Biosimilar Business News Recap: 3 Biosimilar Application Submissions; Roche Sues Biogen
July 26th 2023Formycon and Celltrion announced the FDA submissions for their aflibercept biosimilars; the European Medicines Agency accepted a marketing authorization application for an ustekinumab biosimilar; and Roche filed suit against Biogen over a tocilizumab biosimilar.
Eye on Pharma: Omalizumab Results; Korean Insulin Launch; Quebec to Cover Byooviz
July 12th 2023Kashiv Biosciences announced positive phase 1 results for its omalizumab biosimilar; Dongkook Pharmaceutical shared the launch of an insulin glargine biosimilar (Glargia); and Quebec, a province in Canada, said it’s adding a ranibizumab biosimilar (Byooviz) to its reimbursement list.
Samsung Bioepis Shares 1-Year Phase 3 Results for Eylea Biosimilar
May 2nd 2023At the 2023 Association for Research in Vision and Ophthalmology Annual Meeting, Samsung Bioepis shared comparable safety, efficacy, and immunogenicity data through 1 year between its aflibercept biosimilar (SB15) and the originator (Eylea).
Biosimilars Check In: Vegzelma Launch, BLA Acceptances, China Approval
April 26th 2023Over the past week, Vegzelma, a bevacizumab biosimilar, launched in the United States; 2 biologics license applications (BLAs) for biosimilars were accepted for review by the FDA; and China’s regulatory agency approved a denosumab biosimilar.
SB11 Demonstrates Biosimilarity to Lucentis in Long-term Study in nAMD
April 22nd 2023A long-term follow-up of a phase 3 study comparing ranibizumab biosimilar SB11 to the reference product (Lucentis) in neovascular age-related macular degeneration (nAMD) found the similarity in efficacy end points reported early on was maintained through 52 weeks.
Real-World Study Suggests Comparable Efficacy Between Biosimilar Razumab and Originator in PCV
April 15th 2023A real-world study in India compared the ranibizumab biosimilar Razumab to the originator (Lucentis) in patients with polypoidal choroidal vasculopathy (PCV), finding that the biosimilar had comparable clinical outcomes.
Study: Ranibizumab Biosimilar Found Safe, Effective in Infants With Retinopathy
April 8th 2023A retrospective study from India found that Razumab, a ranibizumab biosimilar, was safe and effective to use in infant patients with retinopathy of prematurity. This is the first analysis assessing the clinical outcomes associated with the biosimilar in this population.