US Food and Drug Administration (FDA) plans to allow some variation in the delivery devices used with biosimilars appears to create a chance for generics players to gain share by improving on the original. Teva has noted the opportunity.
“[Device flexibility] allows me to create some features and benefits of my own that can help with the product. That makes a lot of sense”, William Marth, CEO of Teva North America, said at the Barclays Capital Global Healthcare Conference.
Marth compared the flexibility to the generic injectables sector, in which the Israeli generic giant has used different formulations, such as wet instead of a lyophilised. Using this approach allowed Teva to “create an opportunity for [itself] and actually create a better product for the end user”, Marth said.
Similar thinking is “resident within the thought process of biosimilars”, which Marth said is important for companies entering the emerging sector. As well as allowing for “some design differences in the delivery device” the FDA draft guidance permits variations in the formulation used for biosimilars.
“Pleasantly surprised”
Marth said aspects of the draft guidance left Teva “pleasantly surprised” but “it really hasn’t changed our thinking a whole lot”. A true impression of what the FDA wants will only emerge though as the draft is commented on and companies talk to the Agency about taking drugs along the pathway.
To find out if the pathway is right for biosimilars being developed by Teva it will “spend some time digging”. The complexity of biosimilars means the process, and development of the market, will take time,
“This is something that’s going to develop over years, maybe a decade for us to really get where we need to be”, Marth.