Biosimilar Pharmaceuticals in Canada: Fact Sheet
Prev Post
Biosimilar biologic drugs (also known as “subsequent entry biologics”) were the subject of a paper released by Health Canada in August titled “Biosimilar Biologic Drugs in Canada: Fact Sheet,” which included a detailed overview of a variety of issues concerning biosimilar biologic drugs (also known as “subsequent entry biologics”).
A biosimilar biologic drug, also known as a biosimilar, is a biologic drug that is very close to an already-approved biologic drug (the “reference biologic drug”). A biosimilar and the reference biologic drug are expected to have no clinically significant variations in efficacy and safety.
Biosimilars are approved for sale after a detailed comparison to the reference biologic drug and may enter the market following the expiration of the reference biologic drug’s patents and data security. Biosimilars are approved for sale by Health Canada using the same stringent regulatory requirements for consistency, effectiveness, and protection that apply to all other biologic drugs.
Drugs made from living organisms or their cells are known as biologic drugs. Insulin, growth hormones, and antibodies are examples of biologic drugs. Anaemia, diabetes, psoriasis, hormone deficiency, rheumatoid arthritis, some types of cancer and inflammatory bowelsand other disorders and medical conditions are treated with biologic medications.
Biosimilars are often referred to as “generic” biologics, but they vary from conventional generic drugs in many ways. Biosimilars are large and complex drug molecules since they are generated by living organisms or cells, as opposed to conventional generic drugs, which are chemically synthesised “small molecule” drugs. Traditional generic drugs are identical to the reference product in terms of drug molecule, while biosimilars almost always vary from the reference biologic drug in terms of drug molecule.
The Food and Drugs Act and the Food and Drug Regulations in Canada control biosimilars as new drugs.
Biosimilar sponsors must provide Health Canada with details demonstrating the biosimilar’s resemblance to the reference biologic drug. This is done in a step-by-step manner, starting with structural and functional tests and progressing to human clinical trials.
The type of data needed to support biosimilar authorization varies from that required for reference biological drug approval since the aim of these studies is to show similarity. Sponsors must independently demonstrate the drug’s effectiveness, efficacy, and safety in order to gain approval to market a new active substance (which will be found in a reference biologic drug).
In general, approval of an innovator medication necessitates “pivotal” phase III clinical trials to demonstrate effectiveness and safety of each disease or medical condition that the drug is meant to treat. Sponsors of biosimilars must independently demonstrate the drug’s consistency and conduct comparative studies to show that the drug’s structure, function, effectiveness, and safety are extremely comparable to that of a previously approved reference biologic drug.
A biosimilar could be approved for all or any of the indications that the reference biologic drug was approved for. The indications are determined by factors such as the sponsor’s wishes for the biosimilar and indications protected by intellectual property protection (until the protection expires, which cannot be authorized).
Biosimilar drugs are also evaluated for immunogenicity by Health Canada, which will request a Risk Management Plan for all biologic drugs, including biosimilars. After the biosimilar has been approved, this strategy outlines how the manufacturer can track immunogenicity.
Biosimilars sold in Canada have not shown any unusual post-authorization safety signs, according to Health Canada. Biosimilars approved in Canada have efficacy and safety profiles that are identical to those of their reference biologic drugs. Other countries, such as the United States and the European Union, provide information on drug protection to Health Canada. Biosimilars have been used in the European Union for more than ten years with no unforeseen safety signals.
Welcome to Maven, one of the best Regulatory Consultants that is setup by real life working professionals with very rich experience. We at Maven understand the customers pulse and reach their expectations. We are unique and focus on quality is our prime goal. Maven works with any range of company that is looking for quality and in time delivery of services.
COPYRIGHT © 2022 MAVEN REGULATORY SOLUTIONS.
Leave A Comment