On April 6th, ASBM submitted comments on the FDA’s recently published draft guidance outlining its current thinking on presenting data and information in a truthful and non-misleading way about biosimilars and reference products in FDA-regulated promotional materials.

It addresses questions companies may have when developing these kinds of materials and provides examples that can help with specific situations biosimilar and reference product companies may encounter.

The Draft Guidance is among the deliverables in the FDA’s Biosimilars Action Plan (BAP) that outlines four key strategies to accelerate biosimilar competition, including supporting market competition and providing clearer direction to industry on the development of promotional materials for medical products.

ASBM’s comments reflected observations from ASBM Chair Madelaine Feldman, MD; Advisory Board Chair Philip Schneider MS, FASHP, FFIP; and Steering Committee Member Andrew Spiegel, executive director of the Global Colon Cancer Association. From the comments:

One thing we’ve seen across Europe is that as more and more biosimilars are launched in a given product class, competition drives prices downward, discounts increase substantially, and biosimilar market share goes up. So we know what to expect, and what things to look for.

Thankfully we are seeing this happening in the US. Here we have a biosimilar filgrastim that launched with a relatively low 15% discount over its reference product. Today, with increased competition, that product has attained a majority share of the US market in its class with 55%. Late last year we saw the first rituximab biosimilar launch at a 10% discount over the reference product, and only a few months later the second launched at a larger, 24% discount.

We have every reason to believe this pattern will continue as we see it becoming routine for 3, 4, or 5 biosimilars approved for a reference product, and as these come on the market, manufacturers will continue to compete on price- moving from low discounts, to higher discounts.

ASBM representatives participated in a joint FDA/FTC Public Workshop held on March 9th at the FDA’s headquarters to discuss the guidance; as well as a related half-day event sponsored by the Hatch Center, Pfizer, and the Biosimilars Forum the following day, entitiled “Biosimilars: Breaking through the Barriers’.


Read ASBM’s comments in full here.

View all submitted comments here.