Biosimilars: Three things you need to know

We’ve had the good fortune to work with a biosimilars client this year. Working in this space has given us an opportunity to read and listen to many experts in this enormous area. More recently, we also attended a panel discussion at BIO Europe 2012 on the subject.

Looking through our project notes, there are three key things we’ve learned this year:

It won’t be easy – It sounds obvious in hindsight, but biosimilars is and will continue to be extremely challenging to develop, manufacture, and market. I’m sure many of you will recall the earliest discussions surrounding biosimilars, where entry would be straightforward, regulatory paths would be clear, and prices for expensive biologics would plummet.

The reality, of course, has been quite different, especially in the US. Without a clear regulatory path, the US market is largely closed. In fact, we applaud European regulators for taking the lead on this issue (Brazil as well). At this point, we don’t see the US market opening any time soon, especially as the innovators of these expensive biologics continue to fight biosimilars regulation (and who can blame them?).

Limited Competition –  During the early days of biosimilars, too many analysts were suggesting that biosimilars are exactly like small molecule generics. Thus, there will be multiple competitors for each molecule, creating a robust competitive environment for multi-billion dollar NCE businesses.

Again, the reality has been quite different. Many companies have struggled just to create cell lines and manufacture biosimilars, let alone distribute them. Now we are hearing reports that physicians are reluctant to prescribe biosimilars off label:

Survey findings suggest that in order for gastroenterologists and rheumatologists to feel comfortable prescribing a biosimilar, a randomized, Phase III trial comparing the biosimilar to its reference brand would be required in all indications. This differs from regulatory guidance in the United States, Europe and Japan which states that indication extrapolation is permitted, as long as it is scientifically justified by the applicant.

This is extraordinary, considering that physicians have no problem prescribing off-label small molecules in the absence of Phase III data! Does this mean physicians will also hesitate to prescribe biosimilars for on-label indications without detailing?
The potential implication is that biosimilars will require significant sales and marketing effort to convince physicians to prescribe biosimilars, even for on-label indications. If so, then the marketing of biosimilars will be relegated to a) companies who already market biologics, and b) companies willing to make the marketing and sales investments necessary to establish the biosimilar.
How ironic that a sales and marketing effort may be needed for biosimilars. This will cost money, thereby reducing the cost savings that biosimilars were intended to provide!
Advanced Assets Required – Companies who want to play in this space will need advanced assets. By advanced we mean cell lines with demonstrated Preclinical/Analytical bioequivalence, supported by Phase I data using bioreactor-level clinical supply. This is actually analogous to the small molecule space, where formulations supported by a small Phase I study versus branded comparator stand the best chance of being licensed.
We believe that the biosimilars market will eventually take off and flourish, especially in the US. Some of these biologics are simply too expensive for governments to afford. So the demand for lower prices will likely spur biosimilar regulation and market evolution. But when will this happen? So far, at least from the US perspective, it will not be in the near term. But we hope we are wrong.  
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