Biologics & Biosimilar drugs
- August 6, 2021
- Posted by: OptimizeIAS Team
- Category: DPN Topics
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Biologics & Biosimilar drugs
Subject: Science and Technology
Context: Aurobindo Pharma is working on commercialising a multitope peptide-based Covid vaccine, in collaboration with US-based company Vaxxinty
Concept:
Biologics
- When you think of drugs you often think of chemical compounds like aspirin, a pill that you can pick up from your local pharmacy or supermarket. Biologic drugs are different. They are proteins made by living organisms, whereas traditional drugs are chemicals, referred to as small molecules. Biologic drugs are much larger in size than “small molecule drugs” like aspirin.
- Biologics or biological products are medicines made from living organisms through highly complex manufacturing processes and must be handled and administered under carefully monitored conditions.
- Biologics include a wide variety of products such as gene and cell therapies, therapeutic proteins, monoclonal antibodies, and vaccines.
- Biologics are used to prevent, treat or cure a variety of diseases including cancer, chronic kidney disease, diabetes, cystic fibrosis, and autoimmune disorders.
Biosimilar
- A biosimilar is , it is a biologic that is “similar” to another biologic medicine (known as a reference product), Biosimilars are highly similar to the reference product in terms of safety, purity and potency, but may have minor differences in clinically inactive components.
- Biosimilars are not new drugs, but rather they are copies of biologic drugs that have been used to treat many diseases and conditions. Familiar biologic drugs include widely prescribed therapies like etanercept, infliximab, adalimumab and others.
- Each biosimilar is made using the same amino acid starting materials and the same precise, step-by-step processes as its reference drug a well-tested, widely used biologic drug that’s already been on the market for years. All biosimilars are prescription drugs.
- Biosimilars as sort of like generic drugs not true, since biosimilars are not completely identical copies of their reference drugs.
- Biosimilars use the exact same starting materials and similar manufacturing processes as the original biologic. They are designed and developed to be highly similar to the original drug upon which they are based, and they will not be approved as a biosimilar if they are not.
- They’re made of biological materials (bio-) and are highly similar to an approved, widely tested, and prescribed biologic