Search results for "Biosimilar"

The PROSIT Cohort of Infliximab Biosimilar in IBD: A Prolonged Follow-up on the Effectiveness and Safety Across Italy.

2019

BACKGROUND We report a prospective, nationwide cohort evaluating the safety and effectiveness of CT-P13. METHODS A structured database was used to record serious adverse events (SAEs), clinical remission/response, inflammatory biomarkers (CRP and calprotectin), and endoscopic findings. RESULTS Eight hundred ten patients with inflammatory bowel disease (IBD) (452 Crohn's disease [CD]) were enrolled. Four hundred fifty-nine patients were naive to anti-TNFα (group A), 196 had a previous exposure (group B), and the remaining 155 were switched to CT-P13 (group C). All patients were included in the safety evaluation with a mean follow-up of 345 ± 215 days and a total number of 6501 infusions. One…

OHP-041 Formulary Decision-Making For Biosimilars: Considerations For Hospital Pharmacists

2013

Background It has been 6 years since the first biosimilar was approved for use in the European Union (EU). Given the likelihood that biosimilar monoclonal antibodies will be approved in Europe in the near future, it is timely to review the formulary selection criteria for biologicals and biosimilars. The European Medicines Agency (EMA) has issued guidelines that define the regulation of biosimilars in Europe and recommend approaches to establish biosimilarity. However, several questions regarding the assessment of biosimilars for formulary inclusion remain unanswered, including those related to manufacturing and drug supply. Purpose To aid hospital pharmacists in developing evaluation crite…

Biosimilars and Novel Insulins.

2019

Background Insulin therapy is the mainstay of treatment for type 1 diabetes and may be necessary in type 2 diabetes. Current insulin analogues present a more physiological profile, are effective, and with less risk of hypoglycemia, but they are expensive. Biosimilar insulins should offer the advantages of insulin analogues at reduced costs. In addition, current rapid-acting insulin analogues are not fast enough to control excessive postprandial glucose excursions in many patients. Areas of uncertainty Biosimilar insulins demonstrated that are safe and effective, but interchangeability and automatic substitution remain an issue. Ultrafast-acting insulins should reduce postprandial hyperglyce…

Biosimilar and generic formulations of novel antidiabetic drugs: the role of liraglutide in clinical pharmacology of type 2 diabetes.

2022

SP0027 Biosimilars: Potential Clinical Differences and European Regulatory Aspects

2014

Although successful drugs, the use of anti-TNFs is limited by their high cost, and in the present climate of economic difficulty, there is pressure to find alternatives that reproduce their effects at a lower price. Due to their large molecular size and structural complexity, anti-TNFs are impossible to duplicate, unlike smaller, chemically-generated compounds, which can be copied. However, unlike generics, biosimilars are similar rather than identical to the original drugs. Determining the level of similarity that guarantees a comparable efficacy and safety represents a new test for the pharmacological market. Biosimilars of smaller biological molecules, such as somatotropin, EPO and GCSF …

Putting the “bio” in “biotherapeutics”/checkpoints for biosimilars/application of biosimilars

2016

Abstract / Executive summary The number of biosimilar medicines on the market is steadily increasing, due, in part, to patent expiration of several top-selling biologic medicines. These three e-learning modules discuss the basic concepts behind biosimilar medicines and highlight key regulatory considerations when using biosimilar medicines in medical practice.

Real-Life Use of Biosimilars in Pediatric Inflammatory Bowel Disease: A Nation-Wide Web Survey on Behalf of the SIGENP IBD Working Group

2022

Objective: The aim was to assess the awareness and real-life use of biosimilars in inflammatory bowel disease (IBD) among the members of the Italian Society of Pediatric Gastroenterology, Hepatology and Nutrition (SIGENP). Methods: An anonymous web survey involving all SIGENP IBD units which can prescribe biosimilars was conducted between July 1st and December 1st, 2020. The questionnaire included 18 questions addressing the most relevant aspects of biosimilars in pediatric IBD, i.e., advantages, disadvantages, costs, traceability, general knowledge, and real-life use. A descriptive analysis of responses was performed. Results: Responses came from 26 pediatric IBD units in Italy, with repre…

Pharmacy and pharmacology of biosimilars

2008

Biosimilar medicines are biological medicinal products that can obtain a marketing authorization in the EU after the original product (biological reference medicine) has run out of patent. As a prerequisite, studies including clinical trials are to be conducted to compare the quality, safety, and efficacy of the biosimilar and reference medicine. Due to the specific characteristics of biopharmaceuticals like complex 3-dimensional (glyco) protein structure, immunogenicity, production in living organisms, which causes heterogeneity, complex manufacturing process and analysis, interchangeability of the biosimilar with its reference drug product is not guaranteed. In addition, INN (internationa…

Comparison of clot lysis activity and biochemical properties of originator tenecteplase (Metalyse®) with those of an alleged biosimilar

2014

The bioengineered tissue plasminogen activator tenecteplase is an important treatment modality of acute myocardial infarction recommended by international guidelines. Following introduction of originator tenecteplase (brand names Metalyse(®) and TNKase(®)), a "biosimilar" tenecteplase became available for commercial use in India under the brand name Elaxim(®) in the absence of Indian biosimilar guidelines which came into force from September 15th, 2012. Based on a report of biochemical and fibrinolytical differences between Metalyse and Elaxim, we have systematically compared them in a range of routine quality testing assays. As compared to Metalyse, Elaxim exhibited less clot lysis activit…

Ensuring the Consistency of Biosimilars

2017

Background: Biological products are subject to constant reappraisal by regulatory agencies and pharmaceutical companies once they have entered the market, since every improvement in their manufacturing process has the potential to alter the basic properties of these molecules. Methods: Narrative review focusing on scientific literature as well as legal documents from regulatory agencies. Results: Evaluating the impact of each manufacturing change of these drugs requires rigorous analyses in proportion to the anticipated risk of inducing more or less molecular micro-heterogenicity. There are currently more than 30 biosimilars of TNF-alpha blockers at different stages of testing, each with a …