We have previously discussed (here and here) the conflicting incentives which confront the developers of follow-on biologics when deciding whether to seek approval under the biosimilars pathway or under the standard biologics license application pathway long available for new molecular entities.

Some recent statements made by a leader in the U.S. biosimilar development community confirm the difficulty of this choice and reiterate the industry's need for clarity in the biosimilar approval pathway requirements before committing to this route.

Sumant Ramachandra, senior vice president for research and development, and regulatory and medical affairs and chief scientific officer at Hospira, was recently quoted in FDA Week (Sept. 23, 2012 Vol. 18 No. 37 (yes, it is dated in the future)) on the need for reliable biosimilars approval requirements. 

"Once you are collecting user fees, people have got to know what pathway you are going down," he told FDA Week. "A lot of things have to be fixed before that (Oct. 1) otherwise you leave people paying a fee to you to guess what you are going to do."

 As reported by FDA Week:

Ramachandra said FDA needs to make the biosimilars pathway predictable, including defining and clarifying the type of data that will be required so "people are not guessing their way down the pathway," adding that the agency needs to provide sufficient guidance so companies are not stuck "playing a game" with FDA regarding what types of studies they will need for approval.

 Further, Ramachandra expressly addressed the choice between BLA and the biosimilar pathway:

 "Some companies may say 'I don't want to go through the hassle of the (biosimilar) pathway if the BLA pathway is clearer to me and I have a marketing and sales force around it. I am going to go down the BLA pathway to avoid the hassle of the (biosimilar) pathway'," he said, adding that other companies may choose the abbreviated pathway if there is the ability to base approval on a reference product and less sales and marketing is required. 

So, if the biosimilar pathway presents uncertainty in timing or cost, and your company has the sales and marketing infrastructure to market a new molecule, you may still prefer the BLA route.  The BLA route will also afford a jump on biosimilar competitors who have to wait for the 12 year exclusivity period to end before their products can be approved, and the opportunity to market your product as a differentiated, improved molecule.

With so many biologics with patent expiries on the horizon, we should start to see these manufacturers choices before too long.