nclude assessment of toxicity and a clinical study that includes assessment of immunogenicity and pharmacokinetics or pharmacodynamics are required since they are sufficient to show safety, purity and strength in one or more appropriate conditions of use for which the reference product is licensed. There must also be demonstration of comparable quality from the initial development (Patrawala, 2010). There are additional risks that come up with biosimilars. Immunogenicity and switch related issues are risks that are brought about by biosimilars. These risks reduces quality, efficacy and safety of biosimilars to patients that use them.
The challenges associated with the approval of biosimilars include ability to switch, immunogenicity, and traceability of batches. Other challenges that the managing bodies have encountered when approving the Biosimilars include indication extrapolation, interchangeability, and substitution. To offset the challenges mentioned, the European Medicines Agency has come up with regulatory measures in meeting the development and approval of this biosimilars. However, the goal-oriented strategies steered by the objectives are portrayed in one part of their products for the patients, which has now followed the Europe’s approach. To offset this problem, there is a need for transparent labeling of product information for biosimilars so that the patients and the physicians can use to make an informed decision.
ABPI has set of codes that ensure companies devote considerate resources to that their activities are compiled with. Any complaint that is made against the company is taken as a serious matter both by the industry and the company. Sanctions are also applied agianst a firm that is rule against the breach of code (, 2015). Consequently, firm must ensure that every personnel are well trained according to the code and need to have a robust operating procedures where all the activities and materials within the code are reviewed