Here are the key points, including figures, that emerged out of the discussion:
-An estimated 277 companies are developing biosimilars worldwide. A company developing a biosimilar may not be fully aware of how many potential competitors are working on the same product.
-Given the number of companies currently involved in developing and launching biosimilars, a biologic may see 20 or 30 biosimilars rather than 3 or 4 as has been supposed. This will impact pricing of biosimilars.
-Some companies in India and China have had products on market for nearly 15 years approved under the framework used for generics. Their governments have lately got down to framing guidelines that will be used to approve biosimilars in future.
-India’s recent guidelines attempt to define a broad approach but details will emerge once the industry has had an opportunity to look at them and come up with suggestions. Globally, regulators have borrowed from European, and American approaches while framing guidelines. India is no exception.
-The new Indian rules could help to reduce time to regulatory approval. This is because requirements, up until now, were ad-hoc and somewhat unclear. The new guidance brings clarity.
The following Quintiles executives were present at the round table : Amar Kureishi, chief medical offer and head of drug development, Quintiles Asia, William Lee senior director and head of regulatory strategy also for Asia, and Shoibal Mukherjee, chief medical officer, Quintiles India and head of its Asia Medical Sciences group.
Pic courtesy WealthofHealth4 on Flickr