PRx Blog

Biotech Entrepreneurs Must Be Heard in Biosimilars/FDA Regulatory Pathway Debate

Have we at last reached the point where U.S. lawmakers finally establish an FDA regulatory pathway for follow-on biologics? The Zeitgeist says it is so. You can feel it, see it, hear it and know it. There is just way too much hurting in this economy and far too much of a mandate for healthcare reform for political gridlock or inertia to win out.

And now, as they say, the Devil is in the Details, because we have a plethora of competing bills to debate. If the stars are aligned, H.R. 1548, the Pathway for Biosimilars Act and a forward-thinking piece of bipartisan legislation co-authored by Representatives Anna G. Eshoo (D-CA), Jay Inslee (D-WA) and Joe Barton (R-TX) will be the result. H.R. 1548 is a win-win-win for patients and families who desperately need more affordable access to safe and properly-manufactured life-saving biologics, for payers and employers seeking to cut costs, and for an industry whose innovation and high-wire risk-taking can’t even exist if investor incentive is squelched.

With some kind of regulatory pathway seemingly inevitable for follow-on biologics, the stakes are higher than ever to make sure that H.R. 1548 or some reasonable facsimile emerges. Industry would be wise to more prominently feature the voice of clinical stage biotechnology companies and entrepreneurs in this debate. Early evidence suggests this may not be happening enough. Too many of the press releases and op/ed’s on this issue are being churned out by the global giants, cultivating an impression that the biotechnology industry and Big Pharma are one and the same. While consolidation, M&A and licensing agreements have brought about de facto convergence, we should know by now that Big Pharma’s voice doesn’t evoke much sympathy in the Court of Public Opinion.

But winning this battle isn’t just a matter of clever scripting and casting for a lobbying campaign. Entrepreneurial biotechnology companies will always be the most bountiful source of innovation in this industry. The potential for significant therapeutic advances depend on them. Big Pharma needs them for aging pipelines. It’s a daunting landscape right now for these companies. About one-third of them only have six months of operating cash left. Seed and venture capital are drying up. Investors and partners are increasingly opting out of deals and walking away from projects both early and late. The Public Markets are a non-starter. The wrong kind of FDA regulatory pathway could make this group even more of an endangered species by discouraging early stage investment in these most highly speculative ventures. The regulatory pathway debate must be as much about preserving innovation as it is making biologics more affordable, and industry is certainly “on message” in this regard but Big Pharma just isn’t the best messenger.

If industry doesn’t want the regulatory pathway debate to succumb to the political grandstanding tactics that are always aimed at the drug industry, then it must galvanize the voices of innovators, not just big marketers. Biotech entrepreneurs have the most authentic and sympathetic voices to define what separates biotechnology from pharmaceuticals in terms of innovation, the complexities of safely replicating therapies, the cost of discovery, R&D and materials, the uncertainty of survival and why there’s a need for a Pathway that provides longer-term protection of IP for biologics in the first place.

For their sake – for everybody’s sake – it’s time for industry to help these voices be more forcefully heard.

Schwartz will be at the International BIO Conference in Atlanta so please stop by our booth #4715 to chat if you'd like to.