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4 days ago | 
ajmc.com | Giuliana Grossi |Skylar Jeremias |Eva Szigethy |Benjamin Cohen
The Specialty Medical Home model is reshaping care for people living with inflammatory bowel disease (IBD). IBD, which includes Crohn disease and ulcerative colitis, is a complex, chronic condition that affects millions of people and requires more than just medical management.
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4 days ago | 
centerforbiosimilars.com | Skylar Jeremias
CT-P39, an omalizumab biosimilar, and reference omalizumab demonstrated comparable efficacy, pharmacokinetics, pharmacodynamics, safety, and immunogenicity, as well as quality of life impact, in patients with chronic spontaneous urticaria, as confirmed by a 16-week follow-up of a phase 3 trial.1 CT-P39, also known as Omlyclo, was approved by the European Medicines Agency in May 2025 as the first omalizumab biosimilar.2 The biosimilar was also approved by Health Canada in December 2024 and the...
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1 week ago | 
ajmc.com | Skylar Jeremias
Good news for adults battling a specific type of blood cancer: on June 18, 2025, the FDA gave its stamp of approval to tafasitamab-cxix, known commercially as Monjuvi, to be used in combination with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL).1 This approval offers a promising new treatment option for patients whose disease has returned or hasn't responded to previous therapies.
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1 week ago | 
centerforbiosimilars.com | Skylar Jeremias
Overcoming barriers to insulin access and adherence—particularly with biosimilar insulins—requires robust real-world evidence (RWE) and purpose-built data systems to improve diabetes outcomes and inform health policy, according to a review.1 The narrative literature review, published in Diabetes, Obesity and Metabolism, was conducted to address persistent challenges in realizing the full benefits of insulin therapy and to emphasize the importance of RWE in evaluating the safety, efficacy, and...
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1 week ago | 
centerforbiosimilars.com | Skylar Jeremias
Alvotech and Dr. Reddy’s Laboratories have announced a strategic partnership to co-develop, manufacture, and commercialize a biosimilar candidate referencing Keytruda (pembrolizumab), one of the world’s top-selling cancer immunotherapies.1 Keytruda, which is expected to lose market exclusivity in 2028, generated $29.5 billion in global sales in 2024 and is used to treat multiple cancer types, including melanoma, non-small cell lung cancer, and classical Hodgkin lymphoma.
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1 week ago | 
centerforbiosimilars.com | Skylar Jeremias
Celltrion announced the FDA had approved a new formulation of Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab). The approval, for a 45 mg/0.5 mL solution in a single-dose vial for subcutaneous injection, significantly broadened dosing flexibility for pediatric patients aged 6 to 17 years who weigh less than 60 kg and live with plaque psoriasis (PsO) or psoriatic arthritis (PsA).
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1 week ago | 
centerforbiosimilars.com | Skylar Jeremias
The FDA’s decision to grant an interchangeable biosimilar designation to adalimumab-fkjp, marketed as Hulio, will be driven by compelling evidence from a pivotal clinical study that demonstrated the product’s equivalence to the reference biologic, the data from which were published in Advances in Therapy.1 Interchangeability designations allow pharmacists to substitute a qualifying biosimilar for reference adalimumab (Humira) without prescriber intervention, allowing for easier and quicker...
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2 weeks ago | 
centerforbiosimilars.com | Skylar Jeremias
In response to the need for more real-world evidence on adalimumab biosimilars, new findings from a large cross-sectional survey across France, Germany, Italy, Spain, and the UK offer compelling insights into the practical benefits of ABP 501 (Amgevita/Amjevita), a leading adalimumab biosimilar.1 The treatment of debilitating immune-mediated inflammatory diseases (IMIDs) like rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), and psoriasis (PsO) has seen a...
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2 weeks ago | 
centerforbiosimilars.com | Skylar Jeremias
In the first quarter of 2025, leading biosimilar developers Sandoz, STADA, and Samsung Bioepis each reported strong financial results fueled by robust biosimilar performance. The collective momentum underscores the accelerating commercial success and profitability of biosimilars globally, particularly in immunology and oncology, positioning these companies for continuous growth through expanded portfolios and new product launches.
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2 weeks ago | 
centerforbiosimilars.com | Skylar Jeremias
The latest IQVIA Institute for Human Data Science report highlighted a crucial challenge for the biosimilar industry: bridging the knowledge gaps among health care professionals (HCPs) to unlock the full potential of these cost-efficient alternatives.1 This came as the industry continued its robust trajectory, driving significant cost savings and expanding patient access to critical biologic therapies.
