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Biosimilars have faced significant challenges in their analytical characterization. This process involves a comprehensive analysis of the biosimilar’s molecular structure, biological activity, and other quality characteristics to demonstrate similarity to the reference product. link] KBDNA. 2024, May 17). link] Lawless, L.
The International Generic and Biosimilar Medicines Association (IGBA) has released a report titled “Gaming the System An Overview of Originator Companies Evergreening Strategies Used to Hinder Access to Generic and Biosimilar Products.” Practices previously seen in the U.S.
Keytruda is a cancer immunotherapy, which stimulates the immune system to attack tumor cells and is the best-selling medicine in the world. patent expires in 2028. The subcutaneous injection could be given in a doctor’s office every six weeks, instead of requiring a 30-minute IV drip at the same interval.
The alliance leverages both companies’ experience in the field of biosimilars. This agreement demonstrates Alvotech’s ability to leverage its dedicated R&D and manufacturing platform for biosimilars, accelerating the expansion of our pipeline by pursuing growing global markets.
Michael Reilly in RealClearHealth: Don’t Let a “Lame Duck” Congress Gamble with Patient Health On December 20th, RealClearHealth published an op-ed by ASBM Executive Director Michael Reilly discussing concerns that the Biosimilar Red Tape Elimination Act would lower standards for biosimilar medications.
Biocon Biologics has secured multiple market access agreements for Yesintek (ustekinumab-kfce), its biosimilar to Stelara (ustekinumab). Yesintek is a monoclonal antibody that disrupts IL-12 and IL-23 mediated signaling associated immune mediated diseases. The available presentations are 45 mg/0.5 mL PFS, 90 mg/mL PFS, 45 mg/0.5
Prior to October 2024, the Advisory Committee on Immunization Practices (ACIP) recommended use of a PCV only for all adults aged 65 years and older, including those aged 19 to 64 years with risk conditions for pneumococcal disease.
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Wick, MBA, RPh, FASCP Key Takeaways Pharmacists can address SDOH by providing patient-centered care, promoting immunizations, and offering point-of-care testing to improve health outcomes. Addressing pharmacy deserts and enhancing interdisciplinary collaboration, especially with social workers, are crucial for improving health care access.
4 Novak added that these services align well with appointment-based models and can be layered with immunizations, chronic disease monitoring, and medication therapy management. Addressing Barriers and Finding Solutions Despite the promise of these services, challenges remain.
The study aimed to evaluate both safety and preliminary efficacy outcomes, with a specific focus on hematologic toxicity, pharmacokinetics, and immune system effects. Patients were trained to self-administer their infusion at home or attend clinic visits 3 times weekly.
Related Videos Related Content Advertisement June 16th 2025 FDA Approves Ustekinumab-Stba, Biosimilar to Stelara, for Pediatric Patients With PsO or PsA Gillian McGovern, Associate Editor June 3rd 2025 S2. Subscribe Now!
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During the session “Collaborative Practice, Statewide Protocols, and Independent Prescriptive Authority: How Pharmacy is Expanding Services to Increase Access to Patients,” Klepser highlighted the importance of moving beyond product dispensing to provide higher-level services, such as immunizations and medication therapy management.
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link] Newsletter Stay informed on drug updates, treatment guidelines, and pharmacy practice trends—subscribe to Pharmacy Times for weekly clinical insights. Subscribe Now!
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Misconceptions about biosimilars include doubts about their safety, efficacy, and risks associated with switching from reference biologics. Biosimilars extend beyond cost savings, improving access to essential treatments, especially in underserved populations.
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Receiving CAR T therapy can take several weeks, and though very effective against difficult-to-treat cancers, it can sometimes cause life-threatening adverse events, such as cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS).
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Related Videos Related Content Advertisement June 11th 2025 Perioperative Nivolumab Shows Long-Term EFS, Favorable OS in Resectable NSCLC Luke Halpern, Assistant Editor June 3rd 2025 S2.
Have you observed these immune-related toxicities in your practice, and if so, how are they being managed? All patients should have immunotherapy first. Pharmacy Times : As immunotherapies expand into the solid tumor space, clinicians are reporting cases of ICANS and CRS. It was approved last year.
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However, patients with CLL/SLL typically have a higher risk of serious infection due to their compromised immune systems, raising concerns about the association between CLL/SLL-directed therapies and serious infection risks.
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