Continuous downstream processing of biopharmaceuticals

With the emergence of biosimilars as a new class of biotherapeutic agents, the use of these products in Latin America has become a focus of attention. To aid policymakers and regulatory authorities, a group of experts on biosimilars developed a series of recommendations for the regulation of biosimilars and their implementation in the region. Although most of the Latin American countries have adopted, in general, the WHO recommendations; there are some of them whose regulations diff er from WHO. Unfortunately, the pace at which the region moves toward reaching its potential of having safe and eff ective biosimilars has been slow. Countries in the region must enhance their eff orts to improve pharmacovigilance to include training more regulatory staff , more public and professional awareness on the importance of reporting adverse events and better systems to capture and analyze data. Regulatory authorities should also establish a process whereby the traceability of an adverse event to a biosimilar can be determined. Products previously approved as ‘intended copy’ drugs should be evaluated according to regulations specifi c to biosimilars. It cannot be assumed that a previously approved biopharmaceutical is actually a biosimilar, regardless of current clinical experience. Latin America is no exception to the slower-than-expected pace of developing regulations on biosimilars. The panel’s perspectives on the current status led to six major recommendations in order to enhance the safe use of biosimilars in the region.

/pdf/recommendations-for-the-regulation-of-biosimilars-and-their-4019njf5or.pdf

Recommendations for the regulation of biosimilars and their implementation in Latin America

Purpose
Erythropoiesis stimulating agents (ESAs) are used to treat anemia in critically ill patients. This indication is off-label, because it is not licensed by regulatory authorities. Recently ESAs were suspected to harm critically ill patients. Our objective was to assess the safety of ESAs in off-label indications in critically ill patients.

Safety of off-label erythropoiesis stimulating agents in critically ill patients: a meta-analysis

In the past few years biosimilars have penetrated the market following the expiry of patents of originator variants. This offers the opportunity to apply high-tech protein products at a lower cost. In contrast to small-molecule generics, clinicians and pharmacists have found it difficult to judge the efficacy and safety profiles of complex protein products. In recent years, the European Medicines Agency (EMA) has gained knowledge on assessing comparability between biosimilars and originator products in scientific and legal areas. This article provides an overview of an extensive set of 31 previously drawn biosimilar selection criteria and describes how several of these criteria are covered by EMA regulations and guidelines. A panel of experts (authors) reviewed the criteria and produced a shortlist of 10 criteria relevant for clinicians and pharmacists.

https://ejhp.bmj.com/content/ejhpharm/20/5/275.full.pdf

How to select a biosimilar

The penetration of generic medicines in the pharmaceutical market is influenced, among others, by the consumer’s attitude upon them. The attitude of students in health management and recent alumni is particularly important, as they constitute tomorrow’s policymakers. The aim of our study was to assess their attitude, perception and knowledge towards generic medicines. A cross-sectional study was undertaken, involving students in Health Management and recent alumni. The ATtitude TOwards GENerics (ATTOGEN) validated questionnaire was used, which consists of 18 items, yielding 6 scales (trust, state audit, knowledge, drug quality, drug substitution and fiscal impact), with all item responses expressed on a 5-point Likert scale and higher scores denoting greater disagreement. Correlation coefficients were computed and independent sample tests were performed using non-parametrical statistical methods. A total of 1402 students were interviewed, with a female predominance (62.88%). The mean (SD) scores for the six scales of the ATTOGEN questionnaire were: Trust: 2.877 (0.940), State audit: 3.251 (0.967), Knowledge: 1.537 (0.688), Drug quality: 2.708 (0.971), Drug substitution: 3.828 (1.127) and Fiscal impact: 2.299 (0.860). Trust over generics was statistically significantly associated with all ATTOGEN scales (all p < 0.001). In addition, the increased level of knowledge about generics was associated with recognition of the generic medicines’ quality equivalence (p < 0.001) and positive fiscal impact (p = 0.018). Pharmacists declared having a superior knowledge of generic medicines, being more satisfied with the information they receive about them and strongly believing in drug substitution (p < 0.001). Comparatively to other professionals, pharmacists also indicated substantial differences between branded and generic medicines more often (p < 0.001). They also argued to a greater extent that generic medicines were invented and promoted to resolve the financial crisis of social security institutions at the expense of citizens (p < 0.001). This study demonstrated a mixed attitude of students regarding generic medicines. Trust and knowledge emerged as key factors shaping the students’ attitude towards generics. Among students, pharmacists exhibited a distinct response pattern. This study underlines the importance of addressing and correcting health management students’ misbeliefs about generics’ quality and utility.

/pdf/greek-students-attitudes-perception-and-knowledge-regarding-23uarkcwa5.pdf

Greek students’ attitudes, perception and knowledge regarding generic medicines in times of economic crisis: a cross-sectional study

Importance of the field: Ever since the formation of the first biotechnology company almost three decades ago, more than 150 biopharmaceutical products have been marketed across the globe. The oldest of these biotechnology-derived products are now at the end of their patent lives, as a result of which, the development of ‘biosimilars’ is increasing.Areas covered in the review: The review highlights aspects in which biosimilars differ from generic drugs.What the reader will gain: The active substance of a biosimilar medicine is similar to the one of the biological reference medicine; however, biosimilars differ from generics of pharmacological drugs in aspects like size and complexity of the active substance, and the nature of the manufacturing process. The manufacture of a biopharmaceutical product is complex and involves several isolation and purification steps. These procedures are proprietary to the manufacturer of the originator product and hence even minor changes in production can have serious impli...

Are biosimilars really generics

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Are biosimilars really generics