The Indian pharmaceutical giant, Dr. Reddy’s Laboratories Ltd, has recently launched a new drug ‘Versavo (bevacizumab)’, a biosimilar of Roche’s Avastin. Versavo is designed to treat several types of cancers. As the name suggests, a biosimilar is a biologic medicine that is “similar” to another biologic medicine, often referred to as the reference product.
Understanding Biologics and Biosimilars
Biologics are medicinal products made from living organisms. They are produced through highly intricate manufacturing processes and must be handled carefully. These kinds of medicines are used in the treatment of a variety of diseases such as cancer, chronic kidney disease, diabetes, cystic fibrosis, and autoimmune disorders.
Biosimilars like Versavo, on the other hand, are remarkably similar to the reference product regarding safety, purity, and potency. However, they might exhibit minor differences in clinically inactive components.
The Emergence of India as a Key Player in Biosimilars Production
India has emerged as one of the leading producers of similar biologics. In 2012, the country developed a new guideline for the pre- and post-marketing approval of similar biologics. These guidelines also tackle the regulation of the manufacturing process and ensure the quality, safety, and efficacy of similar biologics.
| Biologics | Biosimilars |
|---|---|
| Medicines made from living organisms | Highly similar to reference biologics |
| Treats a variety of diseases including cancer, chronic kidney disease, etc. | Minor differences in clinically inactive components |
Introduction of Versavo: A new Biosimilar in India’s Market
Dr. Reddy’s Laboratories, a forerunner in the Indian Pharmaceutical industry, has introduced a new biosimilar, Versavo. This drug is a biosimilar to Avastin, a product of Roche’s and is used to treat several types of cancers. The introduction of Versavo in the market is reflective of the growth and innovation in the production of similar biologics in India.
Biosimilars: Regulation and Guidelines
In a move to foster and regulate the growing sector, India came up with guidelines in 2012. These were specifically designed for the pre-and post-marketing approval of similar biologics. The guidelines delve into the regulation of the manufacturing process, ensuring the quality, safety, and efficacy of these similar biologics.