Interview: Biosimilars, a Market Reaching an Inflection Point - A Conversation with Frederic Bouvier

Frédéric Bouvier is a senior biopharmaceutical executive with 25+ years of experience in biologics and biosimilars across Sanofi, Fresenius Kabi, biotech startups, and CDMO organizations. His expertise spans corporate strategy, business development, portfolio build-up, and commercialization, with a strong track record of bringing biosimilars to international markets.

Frederic, everyone talks about biosimilars as a maturing market. How do you see it? 

I actually think the word “maturing” misses the point. Biosimilars are not maturing, they’re just getting started.

If you rewind, the journey began almost 20 years ago. Europe led in the mid-2000s, the US followed a decade later. That phase was about building trust, science and regulatory foundations. What are the drivers of this trend? 

Several forces are converging.

First, confidence has finally caught up with the science. Prescribers now have years of real-world experience and the debate around efficacy and safety is largely behind us.

Second, economics are becoming unavoidable. Healthcare systems are under immense cost pressure and biosimilars offer one of the few proven levers to bend the biologics cost curve. As a result, their use is increasingly incentivized and, in some cases, actively steered.

Third, we’re approaching an unprecedented patent cliff. Over 100 biologics are set to lose exclusivity in the coming years, including multiple megabrands with annual sales exceeding EUR 10 billion.

And finally, regulation is catching up with reality. Clinical efficacy study (CES) waivers are becoming the norm, significantly lowering barriers to entry and accelerating timelines.
Let’s focus on the CES waiver. Why is this shift so transformative? 

Because it removes what was, in many cases, an artificial barrier to competition.

For years, developing a biosimilar meant running long and costly CES, long, expensive Phase 3 trials against the originator. In some therapeutic areas, like rare diseases, this requirement often made biosimilar development structurally impossible.

Yet the evidence tells a different story: when analytical and Phase 1 clinical data are robust, biosimilars consistently perform as expected. In fact, no biosimilar with positive analytical and Phase 1 results has ever failed a CES, and none has revealed meaningful safety or efficacy issues in real-world use.
That fundamentally changes who can compete, what can be developed and how quickly biosimilars can reach patients, right?

Exactly. The playing field is being reshuffled along two dimensions: who can enter and what gets developed.

Historically, biosimilars were the domain of large biopharma. They were the only players with the capital, scale and capabilities to absorb complexity and risk. It was, quite literally, a rich man’s sport. As you stressed, with lower barriers comes more competition. How to win in this new biosimilar paradigm?

That’s the right question.

As barriers fall and competition increases, prices will erode faster and product lifecycles will compress. Some players will exit because the economics no longer meet their expectations. Others will adapt. And new entrants will come in because the market now looks accessible.

There’s a lot of discussion about end-to-end vertical integration as the answer. It may work for a few companies, but I don’t believe it’s a universal solution. For many, it can actually become a distraction.
Looking at current trends, where is investment flowing? Who is stepping into the biosimilars space?

What’s changing isn’t the volume of investment, it’s the profile of the investors.

In the early days, biosimilars were only the territory of large innovator biopharma companies, who could absorb the time, cost and risk of developing a single asset. Then generics players entered the field. They had capital and commercial reach but often relied heavily on external support for biologics expertise.

Now, as barriers come down, a much broader range of companies is stepping in as discussed earlier. Players that historically wouldn’t have considered biosimilars are now actively investing.
Final question: What should senior executives like C-level, VPs of Strategy, Heads of CMC or Outsourcing be thinking about right now?

Two things.

First, the window of opportunity is wide open, but it won’t stay that way for long. As a new wave of entrants builds portfolios, competitive intensity will rise quickly and margins will compress. The advantage will go to those who move early and scale before the market crowds in.

Second, you need an operating model designed for speed and discipline. That means making deliberate choices: the right partners, the right portfolio and a clear focus on where you truly add value versus where external engines can outperform you.

The takeaway is simple. Winning in biosimilars is no longer about doing everything yourself. It’s about scaling efficiently, moving fast and being ruthlessly intentional about how and where you compete.