Regulatory Guidelines and Production Planning Strategies for Biosimilars in the USA

Pharmaceutical sciences- Pharmacy

Abstract

At present, biosimilar projects are ruling the pharma market. This article aims to show that project management is crucialin developing biosimilars. Bad project management will give a bad reputation to the organization, project cost overruns, projectschedule delays, demotivation of the project team, sustainability risk to the organization, and more over huge loss. It is the main reasonmost companies are spending more on the training of employees, particularly on project management. Biosimilars are biologicalproducts that are highly similar to a reference product despite modest changes in therapeutically inactive components. Biosimilarshave no clinically significant changes in product safety, purity, or potency compared to the reference product. With the imminentpatent expiration of certain important high-cost biologics, biosimilar manufacture is becoming increasingly profitable for firms.However, the introduction of biosimilars necessitates the adoption of critical new rules. Because of the inherent differences involvedwith the production methods used by different companies and even different sites within the same company, the existing standardsthat regulate the approval pathways for generic pharmaceuticals are insufficient for biosimilars. Biosimilars are similar to but notidentical to the original. Due to the exclusive nature of the manufacturing line and the techniques employed by these competitors,basic variances in methodology may exist between competing organizations. Even modest variations in the manufacturing process canresult in micro heterogeneity, characterized by minor differences in molecular structure, stability, production cell line behavior, growthconditions, vectors, and purification methods. For these reasons, developing biosimilars takes a lot of work.1 CBER regulatesbiosimilars in the US Market. The reference Medicine's Patent status and market potential should be considered when developingbiosimilars. The main objective of this article is to show that the project management strategies and regulatory approval process areequally important to enter biosimilars into the market. Concerning quality in the project management of biosimilar products, budget,deadlines, and scopes are major constraints. A Gantt chart has been enacted to represent a graphical illustration of a schedule. Ganttchart helps to plan, coordinate, and track specific tasks in a project.