The Price and Market Share Evolution of the Original Biologics and Their Biosimilars in Finland
ConclusionsChanges in pricing policy and the public reimbursement scheme related to the market entry of biosimilars were the main reasons for the decrease in the prices of reference products. Therefore, biosimilars did not generate genuine price competition between biological products. In many of the drug groups examined, the market shares of biosimilars have growth potential in the future. (Source: BioDrugs)
Source: BioDrugs - July 6, 2022 Category: Drugs & Pharmacology Source Type: research

Pharmacists ’ Perspectives of Biosimilars: A Systematic Review
ConclusionsPharmacists ’ knowledge and perception about biosimilars varied and were limited, especially about interchangeability and substitution, efficacy, safety, and indication extrapolation. A better understanding of biosimilars amongst pharmacists could help them to encourage prescribers’ acceptance of biosimilar s. (Source: BioDrugs)
Source: BioDrugs - July 1, 2022 Category: Drugs & Pharmacology Source Type: research

Predictors of Treatment Change Among Patients with Rheumatoid Arthritis Treated with TNF Inhibitors as First-Line Biologic Agent in the USA: A Cohort Study from Longitudinal Electronic Health Records
ConclusionsGender, glucocorticoid use, inflammatory bowel disease, psoriasis, and vitamin D intake were identified as significant predictors of TNFi cycling or switching for TNFi initiators in the RA population. Predicting treatment change remains challenging even with large detailed EHR data.Plain Language SummaryThis study aimed to identify key determinants of treatment changes among patients with rheumatoid arthritis (RA) initiating a tumor necrosis factor inhibitor (TNFi) as their first-line biologic disease-modifying antirheumatic drug (DMARD) in routine care settings using a US nation-wide longitudinal electron...
Source: BioDrugs - June 30, 2022 Category: Drugs & Pharmacology Source Type: research

Tolerability and Reactogenicity Profile of mRNA SARS-Cov-2 Vaccines from a Mass Vaccination Campaign in a Tertiary Hospital: Between-Vaccine and Between-Population Prospective Observational Study (VigilVacCOVID Study)
ConclusionsOur study shows that mRNA-1273 had greater reactogenicity than BNT162b2. Overall, both vaccines had an adequate tolerability profile. mRNA-1273 vaccination caused fewer ARs with milder severity in SOTRs. (Source: BioDrugs)
Source: BioDrugs - June 28, 2022 Category: Drugs & Pharmacology Source Type: research

Progress with RNA Interference for the Treatment of Primary Hyperoxaluria
AbstractOver the last few years, US Food and Drug Administration-approved drugs using RNA interference have come to the market. Many have treated liver-specific diseases utilizingN-acetyl galactosamine conjugation because of its effective delivery and limited off-target effects. The autosomal recessive disorder primary hyperoxaluria, specifically type 1, has benefited from these developments. Primary hyperoxaluria arises from mutations in the enzymes involved in endogenous oxalate synthesis. The severity of disease varies but can result in kidney failure and systemic oxalosis. Until recently, the treatment options were lim...
Source: BioDrugs - June 22, 2022 Category: Drugs & Pharmacology Source Type: research

Allergic Reactions to COVID-19 Vaccines: Risk Factors, Frequency, Mechanisms and Management
AbstractConventional vaccines have been widely studied, along with their risk of causing allergic reactions. These generally consist of mild local reactions and only rarely severe anaphylaxis. Although all the current COVID-19 vaccines marketed in Europe have been shown to be safe overall in the general population, early post-marketing evidence has shown that mRNA-based vaccines using novel platforms (i.e., lipid nanoparticles) were associated with an increased risk of severe allergic reactions as compared to conventional vaccines. In this paper we performed an updated literature review on frequency, risk factors, and unde...
Source: BioDrugs - June 13, 2022 Category: Drugs & Pharmacology Source Type: research

Interchangeability for Biologics is a Legal Distinction in the USA, Not a Clinical One
AbstractBiologics are increasingly vital medicines that significantly reduce morbidity as well as mortality, yet access continues to be an issue even in apparently wealthy countries, such as the USA. While patient access is expected to improve with the introduction of biosimilars, misperceptions in a significant part based on terminology continue to make a sustained contribution by biosimilars difficult. Patients are and will continue to suffer needlessly if biosimilars continue to be impugned. Consequently, it is increasingly urgent that semantics are clarified, and in particular, the implication that interchangeable biol...
Source: BioDrugs - June 13, 2022 Category: Drugs & Pharmacology Source Type: research

Allergic Reactions to COVID-19 Vaccines: Risk Factors, Frequency, Mechanisms and Management
AbstractConventional vaccines have been widely studied, along with their risk of causing allergic reactions. These generally consist of mild local reactions and only rarely severe anaphylaxis. Although all the current COVID-19 vaccines marketed in Europe have been shown to be safe overall in the general population, early post-marketing evidence has shown that mRNA-based vaccines using novel platforms (i.e., lipid nanoparticles) were associated with an increased risk of severe allergic reactions as compared to conventional vaccines. In this paper we performed an updated literature review on frequency, risk factors, and unde...
Source: BioDrugs - June 13, 2022 Category: Drugs & Pharmacology Source Type: research

Interchangeability for Biologics is a Legal Distinction in the USA, Not a Clinical One
AbstractBiologics are increasingly vital medicines that significantly reduce morbidity as well as mortality, yet access continues to be an issue even in apparently wealthy countries, such as the USA. While patient access is expected to improve with the introduction of biosimilars, misperceptions in a significant part based on terminology continue to make a sustained contribution by biosimilars difficult. Patients are and will continue to suffer needlessly if biosimilars continue to be impugned. Consequently, it is increasingly urgent that semantics are clarified, and in particular, the implication that interchangeable biol...
Source: BioDrugs - June 13, 2022 Category: Drugs & Pharmacology Source Type: research