I’m thrilled to sit down with Ivan Kairatov, a renowned biopharma expert whose extensive experience in research and development, coupled with a keen understanding of technology and innovation, makes him a leading voice in the industry. Today, we’re diving into the FDA’s recent push to accelerate biosimilar approvals, exploring how this could reshape drug development, impact costs, and expand patient access to vital treatments. Our conversation touches on the complexities of biosimilars compared to generics, the implications of streamlined regulations, and the broader potential for competition in the biologic drug market.
Can you break down what biosimilars are and why they’re often seen as more challenging to develop than generic drugs?
Absolutely. Biosimilars are essentially copycat versions of biologic drugs, which are complex medicines made from living organisms, like proteins or antibodies, used to treat conditions such as cancer or autoimmune diseases. Unlike generic drugs, which are exact chemical replicas of small-molecule drugs, biosimilars can’t be identical to their reference biologics due to the natural variability in biological systems. This means developers must go through extensive testing to prove they’re highly similar in terms of safety, efficacy, and quality. The process involves intricate manufacturing using living cells, which adds layers of complexity and cost compared to the relatively straightforward synthesis of generics.
How has the slower uptake of biosimilars affected their ability to reduce drug costs compared to generics?
Biosimilars were heralded as a way to slash costs for expensive biologics, much like generics did for small-molecule drugs. However, their market share remains below 20%, and prices haven’t dropped as dramatically as hoped. A big reason is the high barrier to entry—development can take seven to eight years and cost hundreds of millions, deterring many companies. Additionally, branded drugmakers often use tactics like patent thickets or exclusive contracts to delay competition. So, even when biosimilars hit the market, adoption by healthcare providers and payers can be slow due to skepticism or entrenched prescribing habits.
What’s the core purpose behind the FDA’s new guidance on biosimilars announced in late October 2025?
The FDA’s latest guidance is all about speeding up the approval process and cutting costs for biosimilar developers. By removing the requirement for human clinical efficacy trials in certain cases, the agency aims to eliminate redundant steps that slow things down. The goal is to get these drugs to market faster, ultimately fostering competition and making biologic treatments more affordable for patients who often face sky-high prices for these therapies.
How does eliminating the need for human trials change the landscape for biosimilar development?
It’s a game-changer in terms of time and resources. These trials often take one to three years and cost millions—sometimes up to $24 million per study. Skipping them, when the science supports it, can shave off significant delays and expenses, allowing developers to focus on robust analytical testing instead. This shift relies on advanced methods to compare a biosimilar to its reference drug, which the FDA believes can be more precise than human studies in detecting differences.
What kind of financial impact does the FDA anticipate for companies with this policy change?
The FDA estimates that companies could save around $100 million in development costs per biosimilar product. That’s a massive reduction, especially considering past estimates pegged total costs at $100 to $250 million. Lowering this financial hurdle could encourage more players to enter the market, which is critical for driving down prices through competition.
Commissioner Makary emphasized creating more competition and choices for patients. How might this policy help achieve that vision?
By making development faster and less expensive, the FDA is essentially lowering the gate for new biosimilars to enter the market. More products mean more options for patients and healthcare providers, which can pressure branded drug prices downward. It also gives payers—insurance companies and pharmacy benefit managers—more leverage to negotiate better deals, ultimately benefiting patients who need these life-changing treatments but often can’t afford them.
Why do you think biosimilars have struggled to gain a stronger foothold in the market, despite their potential?
There are several hurdles. Beyond the high development costs I mentioned earlier, there’s also a lack of awareness or trust among prescribers and patients about biosimilars being just as effective as branded biologics. Then you have systemic issues like rebate structures that favor branded drugs, or aggressive legal strategies by original manufacturers to block competition. All these factors combine to keep biosimilar adoption low, even when they’re approved as safe and effective.
Can you explain what specific conditions a biosimilar must meet under the new guidance to skip clinical efficacy studies?
Sure. The FDA has outlined that a biosimilar can bypass these studies if it’s produced using a clonal cell line with genetically uniform components, ensuring consistency in manufacturing. It also needs to be highly purified and thoroughly characterized through analytical methods, meaning developers must demonstrate a deep understanding of the drug’s structure and function. These criteria ensure that even without human trials, the biosimilar’s similarity to the reference drug is rock-solid from a scientific standpoint.
How does the FDA’s earlier 2024 proposal on ‘switching’ studies connect to this new policy?
The 2024 proposal was about easing the path to ‘interchangeability’ status by dropping studies on switching between a branded biologic and its biosimilar. Interchangeability means a pharmacist can substitute the biosimilar without a doctor’s approval, which boosts confidence in these drugs. The new 2025 guidance builds on that by further reducing unnecessary testing, aligning with the broader mission to make biosimilars more accessible and practical for everyday use in healthcare settings.
Looking ahead, what is your forecast for the future of biosimilars in light of these regulatory changes?
I’m cautiously optimistic. These FDA policies are a significant step toward breaking down barriers that have held biosimilars back for years. If implemented effectively, we could see a surge in approvals and market entrants over the next decade, which should drive costs down and improve access for patients. However, success also depends on addressing other challenges—like physician education and payer policies—to ensure biosimilars aren’t just approved but widely adopted. I think we’re on the cusp of a tipping point, but it’ll require sustained effort from all stakeholders to truly transform the landscape.
