Biosimilar Medicine for Cancer
- 20 Aug 2019
- 1 min read
Pharma major Dr. Reddy’s Laboratories Ltd has launched ‘Versavo (bevacizumab)’, a biosimilar of Roche’s Avastin in India. The drug is for the treatment of several types of cancers.
- A biosimilar is exactly what its name implies — it is a biologic that is “similar” to another biologic medicine (known as a reference product).
- 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 are used to prevent, treat or cure a variety of diseases including cancer, chronic kidney disease, diabetes, cystic fibrosis, and autoimmune disorders.
- Biosimilars are highly similar to the reference product in terms of safety, purity and potency, but may have minor differences in clinically inactive components.
- India is one of the leading manufacturers of similar biologics. India developed a new guideline in 2012 for the pre- and post-marketing approval of similar biologics. The guidelines also address the regulation of manufacturing process as well as quality, safety, and efficacy of similar biologics.