Learning This Week: Biologicals & Biosimilars
Every week I learn something interesting about a topic.
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Biologicals
Biologicals are a diverse group of medicines and products derived from living organisms. They are generally complex proteins purified from living cell cultures or blood, in contrast to "small molecule" synthetic drugs.
Biologicals go through rigorous testing and regulation to ensure their quality, safety, and efficacy. This includes extensive batch testing at each stage of production to maintain consistency.
In agriculture, "biological" crop protection products are also derived from living organisms like microbes, and are used to control pests, diseases, and weeds. They are an important part of integrated pest management (IPM) strategies, offering sustainability, flexibility, and resistance management benefits compared to chemical pesticides.
Overall, biologicals represent a broad and diverse category of important medical and agricultural products derived from living sources, which undergo specialized development, production, and regulatory oversight to ensure their quality and effectiveness.
Biosimilars
A biosimilar is a biologic medical product that is highly similar to an original biologic product manufactured by another company.
Biosimilars are similar to generics. It is the officially approved versions of original "innovator" biologic products that are manufactured by a different company, usually after the original product's patent expires.
Unlike generic small-molecule drugs, biosimilars cannot be identical copies of the original biologic due to the complexity of biologics. However, biosimilars must demonstrate they are highly similar to the original product in terms of quality, safety, and efficacy.
Biosimilars are approved by regulatory agencies like the FDA and EMA after rigorous evaluation and testing to demonstrate they have no clinically meaningful differences from the reference biologic product.
Biosimilars increase access to important biologic medicines at potentially lower costs compared to the original products.
Examples
Some examples of Indian companies who are prominent in this space are:
Serum Institute, Bharat Biotech, Biocon Biologicals, Biologica E, Shantha Biotech, Dr Reddy’s, Lupin etc
Summary
Biologicals or Biologics are different from regular drugs as they are made from live organisms and are not formula based. Biosimilars are unbranded copies of original biologic drugs that are approved as safe and effective alternatives.
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