As the pharmacological treatment landscape continues to evolve, biologics are becoming increasingly incorporated into therapeutic regimens across a broad range of disease areas.

When these branded drugs lose their patent exclusivity, some companies develop biosimilars, which can offer a cheaper and equally effective alternative to the original medicine, while boosting global accessibility and reinforcing global supply chains.

Despite their benefits, a 2025 analysis from the IQVIA Institute revealed that 90% of biologic drugs facing loss of patent exclusivity over the next decade have no biosimilar competition in the pipeline.

To turn this figure around, Gillian Woollett, VP and Head of Regulatory Strategy and Policy at biosimilars giant Samsung Bioepis, notes that the commercial landscape needs to change.

This interview has been edited for length and clarity.

Annabel Kartal-Allen (AKA): What are the commercial challenges the biosimilar industry is currently facing?

Gillian Woollett (GW): The real issue is the sustainability of viable prices, as we can’t have biosimilars accruing development costs similar to branded drugs with the pricing that comes with developing generics.

Recognising that averages can be very wide, biosimilars are, on average, about 100 times more expensive to develop than generics, meaning developers of the former will need to put in a significantly larger investment up front.

Data from the IQVIA report is telling. If the sector cannot get a suitable level of regulatory and commercial predictability, then there will be problems.

However, even if we do achieve that, the commercial market basing a biosimilar’s value only on price will also make the market unsustainable – even if we now know it’s feasible to make a biosimilar to pretty much any biologic.

Feasibility is established, but the sustainability of the commercial market, in my opinion, is the big uncertainty. For the US, that’s super important, as currently branded medicine manufacturers take 50% of the list price, while biosimilar producers take home less than 10%. The economics have got to change.

AKA: How can the industry close the gap between branded drugs and biosimilar development?

GW: Well, the US has arguably gone the other way, with the IRA and Trump’s Most Favored Nation (MFN) policy. You could say that when there are price controls, you don’t need biosimilars anyway, but that’s not ideal because of the issues around supply chain security.

However, greater transparency around pricing would be a start, as well as more clarity on what intermediaries are doing that takes a large chunk of the revenue. There have been efforts in that direction, but the question is, are they going to be fast enough to close the void when the void is 90%?

While efforts are being made, ultimately, if the patient doesn’t benefit from seeing the cost reduction of using biosimilars, there is no incentive for them to want to use them. These misaligned incentives, whereby the most expensive drug is most likely to be selected and biosimilars aren’t preferred on the formularies, is a big problem.

Sorting out the commercial environment is particularly important, as we see biosimilars as crucial to free up the healthcare dollar.

AKA: How does the global biosimilar regulatory landscape look at the moment?

GW: We’ve had significant progress, as we’re working towards an international guideline to reduce the reliance on comparative clinical efficacy studies. I would say it took 30 years, because it’s bringing in comparability, and what has already been established by the International Council for Harmonisation (ICH), which sets the global standards for the pharmaceutical industry.

The industry has worked on certain goals that have made it into the ICH’s first guideline focused on biosimilars, led by the US Food and Drug Administration (FDA) and Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), with very active involvement from the European, UK, Korean and other leading regulators. This is very important because it allows for harmonised global developmentof both the reference product and the biosimilar. This is probably the single biggest progress the sector has made, and hopefully, we can continue on this path.

AKA: Do you think Makary’s recent resignation as commissioner will have any impact on how biosimilars are regulated in the US within the near-to-mid-term?

GW: No, as the guidance debuted last October and in January this year didn’t change the standards of how the FDA reviews biosimilars, it just changed the data burden associated with regulatory submission.

As I mentioned, these initiatives have been in the works for 30 years and have mainly been driven by technical experts in the FDA. It’s good that then-FDA Commissioner Makary and the Trump administration have supported a more efficient approach by reducing the amount of unnecessary clinical efficacy studies, which is very important in the broader economic and political environment. But Makary himself was not the one writing the rules.

So, the good news is that there’s relative stability at the FDA, and in the Centers for Drugs Evaluation and Research (CDER), where the Office of Therapeutic Biologics and Biosimilars (OTBB) resides.

AKA: Has Trump’s recent manufacturing onshoring push had any impact on where biosimilars are produced, and which countries are currently leading the biosimilar charge?

GW: For Samsung Bioepis, moving biosimilar production to the US is not currently a key focus, per se.

It’s easy to say the US was the first to adopt a US-first approach, but I think everybody is pushing for this at the moment – we’re seeing the same thing in European legislation. Onshoring biosimilar manufacturing to the US is a consideration alongside tariffs, though biosimilars are currently exempt from these.

While onshoring efforts are ongoing in the US, they require time, serious investments and careful supply chain consideration. Regardless of location, setting up the capacity to make medicines is not something that can be done overnight. In Europe, there are considerations that need to be made around the green movement, as well as drugs in water supplies and governance.

AKA: On a global scale, are there any emerging biosimilar markets that stand out to you?

GW: One of the emerging markets that really matters at the moment is South America, with Brazil leading. In Asia, it’s Korea, India and China. However, the issue for some countries is locally manufactured products, and whether they can meet current good manufacturing practice (cGMP) requirements; that’s the case for all medicines.

AKA: What are key legislations currently influencing the biosimilar industry, and how are the impacting the segment?

GW: In the US, there are a couple of things at play. One is the proposed Red Tape Elimination Act, which would make all biosimilars automatically interchangeable upon approval. This act is important, and the FDA has supported it to the extent they can as an agency.

However, the Biologics Price Competition and Innovation Act of 2009 (BPCIA) needs to be tidied up, as drugs developed as the first interchangeable for a reference product currently hold market exclusivity for at least one year, meaning there will be a year-long delay in competition for subsequent interchangeable biosimilars.

The other big one that’s currently being negotiated is the proposed biosimilar user fees, which fund a considerable amount of the FDA’s activities. That’s an absolutely must-pass legislation, because it represents a notable chunk of the agency’s funding.

There are other things that matter to biosimilar developers too, including the Inflation Reduction Act (IRA), the MFN policy and anything introduced by the Centers for Medicare and Medicaid.