Patients ’ Perceptions of Biosimilars: A Systematic Review
ConclusionsThe majority of patients expressed satisfaction with treatment using biosimilars, but limited knowledge continued to impede their perceptions. Doubts about the clinical effects and regulatory approval pathway were identified as major factors that negatively influenced patients ’ attitudes towards biosimilars, while the impact of a price advantage was mixed. It is essential to maintain a focus on educating healthcare professionals about biosimilars, including their clinical outcomes and the regulatory pathway, which equips them to provide comprehensive and informed guida nce to patients. (Source: BioDrugs)
Source: BioDrugs - September 7, 2023 Category: Drugs & Pharmacology Source Type: research
The PROPER Study: A 48-Week, Pan-European, Real-World Study of Biosimilar SB5 Following Transition from Reference Adalimumab in Patients with Immune ‐Mediated Inflammatory Disease
ConclusionsWith the exception of female sex in RA, axSpA, and CD, none of the candidate predictors were associated with SB5 discontinuation. Persistence on SB5 was high, treatment effectiveness was maintained, and no safety signals were detected.Trial RegistrationThis trial is registered with ClinicalTrials.gov: NCT04089514. (Source: BioDrugs)
Source: BioDrugs - August 26, 2023 Category: Drugs & Pharmacology Source Type: research
Neoadjuvant Immunotherapy for Non-Small Cell Lung Cancer
AbstractImmune checkpoint blockade (ICB) has improved outcomes for patients with advanced non-small cell lung carcinoma (NSCLC). Building off of this, it has been hypothesized that the utilization of ICB early during the disease course may be advantageous, particularly in the neoadjuvant setting prior to definitive surgical resection. Preclinical studies have suggested that a more potent immune response may be induced by neoadjuvant ICB in the presence of a higher antigen burden and intact tumor draining lymph nodes. Recent clinical trials evaluating neoadjuvant ICB with or without chemotherapy combinations in patients wit...
Source: BioDrugs - August 21, 2023 Category: Drugs & Pharmacology Source Type: research
Future Evolution of Biosimilar Development by Application of Current Science and Available Evidence: The Developer ’s Perspective
AbstractBiosimilars have been available in the USA for over a decade, and in Europe for almost two decades. In that time, biosimilars have become established in the treatment landscape for a wide range of diseases, facilitating patient access and affordability of healthcare. However, patients can still struggle to access biological therapies in some markets. There is a need to streamline the process of developing biosimilars without compromising their quality, safety, or efficacy. This opinion piece considers the efficiencies that could be achieved within the biosimilar approval process. In clinical trials for biosimilars,...
Source: BioDrugs - August 5, 2023 Category: Drugs & Pharmacology Source Type: research
Recurrent Clostridioides difficile Infection: Current Clinical Management and Microbiome-Based Therapies
AbstractClostridioides difficile is one of the most important causes of healthcare-associated diarrhea. The high incidence and recurrence rates of C. difficile infection, as well as its associated morbidity and mortality, are great concerns. The most common complication ofC. difficile infection is recurrence, with rates of 20 –30% after a primary infection and 60% after three or more episodes. Medical management of recurrentC. difficile infection involves a choice of therapy that is different from the antibiotic used in the primary episode. Patients with recurrentC. difficile infection also benefit from fecal microbiot...
Source: BioDrugs - July 26, 2023 Category: Drugs & Pharmacology Source Type: research
Evaluating Gene Therapy as a Potential Paradigm Shift in Treating Severe Hemophilia
AbstractHemophilia is characterized by a deficiency in coagulation factors VIII or IX. The general standard of care for severe hemophilia is frequent intravenous recombinant or plasma-derived factor replacement to prevent bleeding. While this treatment is effective in preventing bleeding, frequent infusions are burdensome for patients. Nonadherence to the therapeutic regimen leaves people with hemophilia at risk for spontaneous and traumatic bleeds into joints as well as life-threatening bleeds such as intracranial hemorrhage. The chronicity of the disorder often leads to the formation of target joints, causing long-term p...
Source: BioDrugs - July 25, 2023 Category: Drugs & Pharmacology Source Type: research
Unlocking the Power of Complement-Dependent Cytotoxicity: Engineering Strategies for the Development of Potent Therapeutic Antibodies for Cancer Treatments
AbstractThe complement system is a crucial part of the innate immune response, providing defense against invading pathogens and cancer cells. Recently, it has become evident that the complement system plays a significant role in anticancer activities, particularly through complement-dependent cytotoxicity (CDC), alongside antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cell-mediated phagocytosis (ADCP). With the discovery of new roles for serum complement molecules in the human immune system, various approaches are being pursued to develop CDC-enhanced antibody therapeutics. In this review, we f...
Source: BioDrugs - July 24, 2023 Category: Drugs & Pharmacology Source Type: research
Staying Ahead of the Game: How SARS-CoV-2 has Accelerated the Application of Machine Learning in Pandemic Management
AbstractIn recent years, machine learning (ML) techniques have garnered considerable interest for their potential use in accelerating the rate of drug discovery. With the emergence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, the utilization of ML has become even more crucial in the search for effective antiviral medications. The pandemic has presented the scientific community with a unique challenge, and the rapid identification of potential treatments has become an urgent priority. Researchers have been able to accelerate the process of identifying drug candidates, repurposing existing dr...
Source: BioDrugs - July 18, 2023 Category: Drugs & Pharmacology Source Type: research
