March 20th 2024
Two posters presented at the American Academy of Dermatology (AAD) annual meeting examined the effects of switching from reference ustekinumab and adalimumab to biosimilar versions in patients with different types of psoriasis.
Therapeutic Advances in Plaque Psoriasis to Address Unmet Needs in Treatment and Improve Patient Outcomes
1.5 Credits / Dermatology
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Managed Care Considerations for Management of Molluscum Contagiosum: Examining Emerging Treatments
1.0 Credit / Dermatology
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AJMC® Powered by Patients and Managed Care Insights – More Than a Cosmetic Disease: Vitiligo Treatment Approaches and Raising Awareness of the Disease Burden
1.5 Credits / Dermatology
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FDA Green Lights Second Tocilizumab Biosimilar
March 7th 2024The FDA has approved Fresenius Kabi's tocilizumab biosimilar (Tyenne; tocilizumab-aazg), making it the second tocilizumab biosimilar overall and first tocilizumab biosimilar to be approved with both intravenous and subcutaneous administration options.
Eye on Pharma: Canadian Aflibercept Settlement; Sandoz Acquires Cimerli; Payer Chooses Cyltezo
March 6th 2024Biocon 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.
Cardinal Health Report Showcases Biosimilar Growth, Provider and Payer Evolution, and More
February 29th 2024In its annual biosimilars report, Cardinal Health provided updates on how provider acceptance growth, evolving payer dynamics, and the growing pipeline for biosimilars will shape the biosimilar landscape over the next 5 years.
Samsung Bioepis Announces New Biosimilar Partnership, Regulatory Updates
February 27th 2024Samsung Bioepis provided multiple updates on its biosimilar projects, including a new partnership for its aflibercept biosimilar candidate as well as regulatory news in the European Union and Republic of Korea.
FDA Approves 10th Adalimumab Biosimilar, Simlandi
February 24th 2024After receiving 3 complete response letters, Alvotech has officially received US approval for its adalimumab biosimilar (AVT02; Simlandi), making it the first approval for the company, the 10th biosimilar to reference Humira, and the third interchangeable adalimumab biosimilar.
Adalimumab Treatment May Impact Antibody Levels After COVID-19 Vaccination
February 22nd 2024A study investigating SARS-CoV-2 antibody levels after treatment with reference or biosimilar adalimumab found significant decreases in antibody levels in those receiving biologic therapy compared with those who did not.
Eye on Pharma: VA Picks Hadlima; Biocon, Sandoz Partnership; A Stelara Settlement Abroad
February 21st 2024The US Department of Veterans Affairs (VA) has chosen to replace Humira (adalimumab) with Organon’s biosimilar version on its national formulary; Biocon Biologics and Sandoz announce a new partnership in Australia for 2 biosimilars; Alvotech settles with Johnson & Johnson over its biosimilar to Stelara (ustekinumab) for the European and Canadian markets.
Biosimilar Candidate CT-P43 Shows Biosimilarity With Ustekinumab Originator in Plaque Psoriasis
February 13th 2024Similar efficacy, safety, pharmacokinetics, and immunogenicity were found when comparing Stelara, originator ustekinumab, and CT-P43, an ustekinumab biosimilar candidate, in patients with moderate to severe plaque psoriasis.
Analyzing Safety of Switching From Originators to Biosimilars: A Meta-Analysis of 21 Trials
February 10th 2024The authors of a meta-analysis assessing several disease states found no significant differences in serious adverse events, deaths, or treatment discontinuations between patients who switched from reference products to biosimilars and those who did not.
Vizient Report Emphasizes Biosimilar Successes, Impact of Inflation on Drug Spend
February 7th 2024Vizient’s most recent Pharmacy Market Outlook report showcased the success of biosimilars while also emphasizing the impact of inflation on different drug classes, particularly in oncology and immunology.
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.
Q&A With Dr Chelsee Jensen: Navigating FDA Approvals, Challenges in the Biosimilar Landscape
January 14th 2024Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, reacts to the biggest FDA approvals of 2023 and how she sees the adalimumab, natalizumab, and tocilizumab spaces playing out.
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.
IQVIA Report Flags Challenges With Biosimilar Access, Savings Throughout Europe
January 10th 2024IQVIA’s report on the impact biosimilar competition has had on Europe’s health care space identified ongoing challenges with biosimilar access and generating savings, calling for more policies focusing on fostering a sustainable market for years to come.
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.
Study Documents HCPs’ Experiences of a Mandatory Switch to Inform Future Transitions
December 2nd 2023A survey explores the experiences of health care providers (HCP) in New Zealand throughout the transition process following a mandatory switch from the adalimumab originator (Humira) to a biosimilar in 2022.
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).
Public Payer in Poland Saves €243 Million by Using Biosimilar TNF Inhibitors
November 11th 2023The use of biosimilars of tumor necrosis factor (TNF) inhibitors within Poland’s public payer saved over €243 million from 2013 to 2021, with about 68% of that coming from the rheumatic musculoskeletal diseases alone.
Real-World Data Confirm Safety, Efficacy of CT-P13 in Inflammatory Diseases
November 9th 2023A real-world analysis from Japan confirmed that CT-P13, an intravenous infliximab biosimilar, had comparable safety and efficacy to the reference product (Remicade; infliximab) in patients with immune-mediated inflammatory diseases.