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WHEN CHOICE ARRIVES: Competition & Consequences

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BIOSIMILAR APPROVALS

Articles

Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.

Boosting Health Care Sustainability: The Role of Biosimilars in Latin America

Although financial incentives introduced by Japan's 2022 health policy did not result in a reduction in overall drug costs, biosimilar use in oncology significantly increased.

Financial Incentives Boost Oncology Biosimilar Adoption, but Costs Remain Unchanged 

The European Commission grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars.

Eye on Pharma: EU Aflibercept Approvals; Biosimilars Canada Campaign; Celltrion Data 

Sarfaraz K. Niazi, PhD, is an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, and founder of biosimilars companies Karyo Biologics and Adello Biologics. He also founded the biosimilar advisory company PharmSci.

BioRationality: A Proposal to Create a New Association With Rational Scientific Agenda

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Closed-door sessions began last month on possible patent law reform in 2019 in the United States.

Stakeholders Thinking About US Patent System Reform in 2019

Eculizumab must be administered every 2 weeks, versus every 8 weeks for the newly approved ravulizumab. Another possible advantage for Alexion is that the newer drug also has the benefit of new patent exclusivities that could help Alexion stave off the impact of competition from oncoming eculizumab biosimilars. 

Alexion's Second C5 Complement Inhibitor Requires Less Frequent Dosing, Carries New Patents

Civica Rx, the nonprofit generic drug company formed last year by 5 health systems in order to combat drug shortages and high prices for generic drugs, added 12 additional health systems this week, bringing the total to 750 hospitals in the United States joining the venture so far.
 

Hospital Group Making Generic Drugs Adds 12 Additional Members 

Biosimilars offer critical savings and increased access to treatments, but they face substantial barriers before reaching patients. This series for Global Biosimilars Week, a worldwide online biosimilar advocacy event hosted by the International Generics and Biosimilars Association, focuses on 3 major areas where obstacles limit access in the US:

Payer and pharmacy benefit managers (PBMs) policies

 is a media partner for Global Biosimilars Week 2024. Each article in this series will shed light on these barriers and suggest steps to enhance biosimilar access, affordability, and equity.

Dancing With the Companies: The Patent Dance and Biosimilars

The "patent dance" is a structured legal process unique to the biosimilar landscape in the US, designed to help streamline patent disputes between biosimilar manufacturers and reference product sponsors.

 Created as part of the Biologics Price Competition and Innovation Act (BPCIA) in 2010, the patent dance aims to expedite biosimilar entry into the market while balancing the interests of innovators who initially developed these complex biologic therapies.

Currently, the patent dance is a required part of the biosimilar approval pathway and involves an exchange of information regarding patents, infringement, and validity positions 

. This early assessment, often initiated even before any litigation is filed, allows the involved parties to pinpoint and discuss specific patents that might be contested, facilitating earlier settlement discussions and minimizing the scope of costly litigation.

Patent litigation is often resource intensive on both sides. 

 with The Center for Biosimilars, Ha Kung Wong, JD, an intellectual property attorney and partner at Venable, noted that the patent dance has been instrumental in promoting settlements, reducing the need for many cases to proceed to trial.

“The patent dance allows for an early assessment of infringement and validity positions... If you don’t have a problem with the patents, then you can launch without any risk... It’s led to a great number of settlements, very few of them go to trial, which means we're not wasting resources on litigation,” he said.

Although this system has proven effective in fostering negotiation and settlement—ultimately helping to speed up biosimilar market entry—it is not without its criticisms. Some industry stakeholders argue that the BPCIA framework could be further streamlined to make the process less cumbersome and more predictable for biosimilar developers.

 As it stands, however, the patent dance remains a pivotal aspect of the biosimilar approval process, as it narrows down relevant patents and reduces potential legal roadblocks, benefiting both biosimilar manufacturers and original biologic developers.

In essence, the current state of the patent dance in the biosimilar landscape reflects an ongoing effort to balance innovation protection with the need to improve market access and affordability for biologic therapies. This system, while complex, is considered one of the primary drivers of efficient biosimilar development in the US, fostering a competitive landscape that promises greater access to these critical medicines for patients.

But, is the patent dance working? Is it helping biosimilars? What needs to be done to ensure innovation and competition aren’t hindered?

Patent Disputes Leading to Delayed Entries

The US patent system allows drug companies to obtain preliminary patents to obtain market exclusivity on a particular product, as well as patents on aspects like the manufacturing process, device design, development process, and others. This enables companies to create a wall of patents—in some cases, over 100 patents—that can be very difficult for biosimilar and generic manufacturers to comb through.

This creates an environment where originator companies are almost guaranteed to sue their future biosimilar competitors, resulting in launch delays.

Product launch delays leave the door open for companies to enact product hopping, when drug companies shift demand from an innovator drug facing or about to face generic or biosimilar competition to new, patented versions.

Although the first patents for the reference product Humira expired in 2018, biosimilar versions were not allowed to enter the market until 2023, with most not being able to launch until the second half of the year.

Humira’s maker, AbbVie was able to use patent legislation and pay-for-delay deals to get biosimilar companies to postpone launch dates.

 These lawsuits resulted in mass settlements with all adalimumab biosimilar manufacturers coupled with the promise not to launch until 2023, with Amgen’s Amjevita (adalimumab-atto) being the first to launch. Amjevita launched at the end of January 2023, followed by 7 products in July, 1 in October, and 1 in 2024.

The adalimumab biosimilar market has the highest number of products competing against a single originator, and most of the products launched in a 6-month span, the effects of which the US is still trying to observe. Already the delays have enabled AbbVie to convert a lot of its patients from Humira to Skyrizi (rizankizumab-rzaa), another one of its products.

 Although adoption of adalimumab biosimilars has grown significantly throughout 2024, the adalimumab market as a whole is shrinking due to patients switching to another AbbVie product instead of a biosimilar, leaving the sustainability of biosimilars in this space and others in limbo.

Similarly, this has happened with ustekinumab biosimilars, which, thanks to multiple settlements with reference manufacturer Johnson & Johnson, will not launch in the US until early 2025.

 This was pushed back from the initial launch prediction of late 2023 or early 2024.

Aflibercept biosimilars also have been postponed due to litigation. However, in September 2023, a federal judge in West Virginia ruled that originator manufacturer Regeneron cannot immediately restrict Amgen’s US sales of a biosimilar to Eylea (reference aflibercept).

 Aflibercept biosimilars were supposed launch in 2024 but are now expected to start launching in 2025.

The postponement of ustekinumab, aflibercept, and other molecules creates an opportunity for companies to stifle competition and savings for patients by preventing access to lower-cost medications.

Additionally, patent litigation is very expensive for biosimilar manufacturers. Negotiation for settlements coupled with delayed profits from postponing a market launch can make pursuing biosimilar development very unattractive. In fact, 47% of the originator molecules with the potential to have biosimilars in the future do not have biosimilars in development, raising the question of whether companies will continue to see revenue potential from the biosimilar space.

Without policy reform and action, how can biosimilar companies keep up? And how can industry leaders prevent companies from feeling so discouraged by patent hurdles and delayed returns that they consider leaving the biosimilar market for good?

Several policy initiatives aim to promote fair competition in the pharmaceutical market, which is a start. In 2022, Congress directed the Federal Trade Commission (FTC) to address product hopping, leading to an FTC report that highlighted antitrust concerns with brand name companies’ efforts to obstruct competition between original and reformulated drugs.

In January 2023, Senators John Cornyn (R, Texas) and Richard Blumenthal (D, Connecticut) introduced the Affordable Prescriptions for Patients Act of 2023 (S 150).

 The bill, which passed the Senate in July 2024, would ban product hopping and cap the number of patents a brand company can assert against a generic or biosimilar manufacturer at 20, with specific rules for adding new patents. However, Wong questioned whether this would have a practical effect, noting that most lawsuits are based on fewer than 10 patents.

Alas, like most biosimilar reforms in Congress, these pieces of legislation have been stalled, often trapped in committee hearings or on desk holds. Wong commented on the prospect of policy reforms making it out of congressional limbo to address ongoing challenges with the patent system and biosimilars: "Predicting whether there will be statutory shifts or reform in patent law is like trying to predict what will happen in the next Fast & Furious movie—you have no idea what specifically is going to happen but it's probably going to have some explosions that ultimately, will not be applicable to the real world."

Wong recommends that policymakers and other industry leaders keep in mind how patent reforms will impact the entire system and ensure that new policies aren’t implemented haphazardly.

"Reforms, like limiting the number of patents that can be asserted in a patent litigation, might have some effect, but we haven't seen significant changes yet. The challenge is that patents are often filed early in the development process, so it's unclear whether reform would make a big difference for biosimilars unless there are substantial follow-through actions."

1. Menchaca A. The inner workings of the BPCIA patent dance. The Center for Biosimilars. July 24, 2021. Accessed November 7, 2024. 

https://www.centerforbiosimilars.com/view/the-inner-workings-of-the-bpcia-patent-dance

2. Jeremias S, Santoro C. Patent dance insights: a Q&A on reducing legal battles in the biosimilar landscape. The Center for Biosimilars. August 18, 2024. Accessed November 6, 2024. 

https://www.centerforbiosimilars.com/view/patent-dance-insights-a-q-a-on-reducing-legal-battles-in-the-biosimilar-landscape

3. Jeremias S. Biosimilars Council Position paper calls for end to clinical efficacy trials for biosimilars. The Center for Biosimilars. June 4, 2024. Accessed November 7, 2024. 

https://www.centerforbiosimilars.com/view/biosimilars-council-position-paper-calls-for-end-to-clinical-efficacy-trials-for-biosimilars

4. Hagen T. Biopharmaceutical industry representatives discuss product hopping legislation. The Center for Biosimilars. September 24, 2020. Accessed November 5, 2024. 

https://www.centerforbiosimilars.com/view/biopharmaceutical-industry-representatives-discuss-product-hopping-legislation

5. Vaidya M. AbbVie’s successful hard-ball with Humira legal strategy unlikely to spawn similar efforts; potential appeals outcome unclear. Pharmaceutical Technology. February 19, 2021. Accessed November 6, 2024. 

https://www.pharmaceutical-technology.com/comment/abbvies-successful-hard-ball-with-humira/?cf-view

6. Jeremias S. The age of adalimumab is upon us: how stakeholders can prepare. The Center for Biosimilars. June 28, 2023. Accessed November 6, 2024. 

https://www.centerforbiosimilars.com/view/the-age-of-adalimumab-is-upon-us-how-stakeholders-can-prepare

7. Jeremias S. Happy birthday adalimumab biosimilars: reflecting on the first year of US competition. The Center for Biosimilars. January 31, 2024. Accessed November 6, 2024. 

https://www.centerforbiosimilars.com/view/happy-birthday-adalimumab-biosimilars-reflecting-on-the-first-year-of-us-competition

8. Jeremias S. Skyrizi Overtakes Humira: “Product hopping” leaves biosimilar market in limbo. The Center for Biosimilars. November 7, 2024. Accessed November 7, 2024. 

https://www.centerforbiosimilars.com/view/skyrizi-overtakes-humira-product-hopping-leaves-biosimilar-market-in-limbo

9. Jeremias S. Amgen’s Stelara biosimilar delayed until 2025 after settling with J&J. The Center for Biosimilars. May 29, 2024. Accessed November 6, 2024. 

https://www.centerforbiosimilars.com/view/amgen-s-stelara-biosimilar-delayed-until-2025-after-settling-with-j-j

10. Jeremias S. Eye on Pharma: aflibercept legal drama; PBM, Humira biosimilars; denosumab regulatory review. The Center for Biosimilars. October 15, 2024. Accessed November 7, 2024. 

https://www.centerforbiosimilars.com/view/eye-on-pharma-aflibercept-legal-drama-pbm-humira-biosimilars-denosumab-regulatory-review

11. Biosimilars in the United States 2023–2027. IQVIA. January 31, 2023. Accessed November 7, 2024. 

https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/biosimilars-in-the-united-states-2023-2027

Federal Trade Commission Report on Pharmaceutical Product Hopping

. Federal Trade Commission. October 2022. Accessed November 7, 2024. 

https://www.ftc.gov/system/files/ftc_gov/pdf/p223900reportpharmaceuticalproducthoppingoct2022.pdf

13. Affordable Prescriptions for Patients Act of 2023, S 150, 118th Cong (2023). Accessed November 7, 2024. 

https://www.congress.gov/bill/118th-congress/senate-bill/150

Part 1 of this 3-part series for Global Biosimilars Week focuses on legal barriers to biosimilar access in the US, including the patent system, and discusses ongoing legislative efforts to address these challenges.

Business & Practice

Breaking Down Biosimilar Barriers: The Patent System

The prevalence of inflammatory bowel disease (IBD; Crohn disease and ulcerative colitis) is rising, approaching 1% in Europe and North America. According to a recent 

, alongside this increase in prevalence, health care costs associated with IBD are also rising. The authors said that increase in prevalence combined with shifts in IBD care and higher hospitalization costs is increasing the burden on health care systems. They discussed the challenges to making IBD costs sustainable and strategies toward achieving personalized, cost-effective care for IBD.

Direct and Indirect Costs Associated With IBD

Direct costs associated with IBD include ambulatory visits to gastroenterologists, emergency department visits, admissions for hospitalization or surgery, diagnostics, and medications. Although hospitalization rates have decreased, direct costs have not because of a trend toward more complex disease with greater severity, and rising costs of inpatient care. The authors cited The Lancet Gastroenterology & Hepatology Commission which estimated direct health care expenses associated with IBD are $9,000 to $12,000 per person per year in high income regions. However, they noted “these estimates do not fully account for factors such as disease severity, accessibility, and variability in health care infrastructure among regions.”

They also described the US as an “outlier” in direct health care costs. In the US, drug prices on average exceed international prices by several-fold due to a lack of nationwide price regulation, the fragmentation of the health care system, prolonged market exclusivity periods, and confidential rebates negotiated between private insurers and pharmaceutical manufacturers. “Patients seldom benefit” from these rebates, the authors added.

Indirect costs include lost wages from missing work, reduced capacity at work, early retirement, premature death, delayed workforce entry, and not achieving educational or professional potential. Despite studies attempting to quantify indirect costs, the authors wrote, “many aspects remain poorly understood, leading to an underestimation of their actual impact.”

Challenges to Achieving Cost Sustainability

Challenges the authors cited to reducing IBD costs and achieving sustainability include disparities in access, treatment affordability, underinsurance, and a lack of standardized cost-effective care guidelines. Unplanned health care utilization, for example emergency department visits, “drives much of the cost in IBD care,” they wrote, and cited research suggesting that low-income status leads to less access to timely and effective care, leading to unplanned health care utilization, which has detrimental effects on both long-term health and costs. Also, lower income patients may delay or skip treatments or diagnostics with high out-of-pocket costs.

Strategies the authors recommended to reduce costs included early implementation of biologics, a focus on cost-effectiveness in settings with limited resources, and promoting the use of 

. They also recommended several patient monitoring strategies, such as using telemedicine and noninvasive biomarkers of disease activity. In addition to treatment strategies, such as 

 when appropriate, they recommended support strategies, such as using multidisciplinary care models that provide holistic care, promoting healthy lifestyle behaviors, and recognizing barriers to care faced by vulnerable populations. Regarding settings with limited resources, they commented that there are no guidelines for de-escalating or withdrawing biologics, which could help to reduce costs if developed.

There is a “clear benefit” for achieving remission to a top-down approach of starting biologic therapy early, the authors said. However, less than 20% of private insurance companies in the US permit biologics as a first-line therapy for IBD. They added that based on data from Canada and the Netherlands, whether cost savings from avoided hospitalizations and surgeries outweigh the costs of biologic drugs is unclear.

Biosimilars Limited by Patent Thickets and Market Dynamics

Biosimilar uptake in the US has been “relatively modest,” the authors said. One reason is patent thickets created by originator manufacturers to extend market exclusivity, which have limited market entry of biosimilars. Additionally, after market entry, reimbursement dynamics have limited biosimilar uptake, as manufacturers of originators often offer confidential discounts to payers to outcompete biosimilars.

Addressing the increasing direct and indirect costs of IBD “demands a comprehensive strategy, tackling disparities, access barriers, and cost-effectiveness of therapeutics,” the authors wrote. They added that policy reforms to improve access to IBD care will also be required: for example, reforming prior authorization processes, enhancing drug price transparency, and introducing value-based reimbursement structures.

Burisch J, Claytor J, Hernandez I, Hou JK, Kaplan GG. The cost of inflammatory bowel disease care - how to make it sustainable. 

. 2024:S1542-3565(24)00729-8. doi:10.1016/j.cgh.2024.06.049

Clinical

Making the Cost of IBD Care Sustainable

The future of a sustainable biosimilars market in the US depends on strategic legislative reforms, improved education for stakeholders, and a robust reimbursement framework that together enhance accessibility, build confidence, and ensure long-term cost savings in health care, according to a panel of industry leaders.

With $36 billion saved in 2023 and nearly 3 billion days of patient therapy delivered without any clinically significant differences from originator biologics, biosimilars are proving their value in the health care space. The panel discussion took place at the 

 and included representatives from 3 biosimilar manufacturers (Sandoz, Teva Pharmaceuticals, Biocon Biologics).

During the discussion, Sonia Oskouei, PharmD, vice president and US head of biosimilars and specialty at Sandoz, emphasized that true accessibility and sustainability in the US market will require a strategic focus on education and policy that supports patients and providers.

Oskouei, who has a decade of experience working with biosimilars, discussed the critical need for expanding biosimilars across various therapeutic areas, referencing the recent approvals for the first denosumab and aflibercept biosimilars.

 She pointed to the journey from biosimilars being in niche oncology markets to mainstream use, adding that more can be done to sustain this growth by streamlining approval processes and educating the public.

Meanwhile, Mary Pietryga, vice president of global marketing at Teva Pharmaceuticals who has 3 decades of experience working in biopharmaceuticals, described the challenges in expanding biosimilar uptake. Patient and provider education gaps, she noted, continue to limit the full realization of biosimilars’ benefits, and improved awareness could accelerate adoption and cost savings.

Joshua Salsi, head of North America commercial at Biocon Biologics, emphasized that the complexity of the US health care market demands a reimbursement model that balances affordability with high-quality standards. Although interchangeability is a legal designation for biosimilars, he explained, it has not become a deciding factor for providers, who are more focused on therapeutic similarity. The discussion emphasized that clearing up misconceptions about interchangeability is essential to driving confidence in biosimilars.

The conversation also touched on legislative factors, with moderator Craig Burton, senior vice president of policy and strategic alliances for the Association for Accessible Medicines and executive director of the Biosimilars Council, discussing the impact of recent policies. Legislative reforms, the panel agreed, are key to supporting the biosimilars market, as streamlined processes can help reduce economic pressures and improve biosimilar accessibility. Oskouei highlighted that by bolstering FDA resources, legislation could enable faster evaluations and approvals, fostering a more competitive and sustainable market.

The role of pharmacy benefit managers (PBMs) emerged as a critical topic. Pietryga and Salsi outlined the challenges biosimilar companies face in navigating PBM contracts, which often favor established biologics. They noted that if the market could encourage more competition among PBMs, biosimilars would have a better chance to compete fairly. Oskouei reiterated that increasing understanding about PBMs’ role and impact could benefit all stakeholders and improve patient access.

"The reality is, especially over the last 5 years, as more [innovator] biologics and the biosimilars to those biologics are being introduced into the marketplace, the US specifically is performing as a high grip market…. Decreasing the cost and time of your resource allocation to get these molecules to market is critical. Ensuring the marketplace to launch these assets into is also critical. I think that we truly are this inflection point to ensure that the success and the adoption of biosimilars continues to have the utmost sustainability moving forward,” commented Salsi.

Lastly, the panel discussed the implications of the Inflation Reduction Act (IRA). Pietryga detailed that while the IRA’s cost-saving intentions are commendable, its effects might limit biosimilar competitiveness unless paired with sustainable reimbursement.

“You have really beneficial payers, and they're aligned to PBMs and specialty pharmacies, and they each take 1 manufacturer. So, you end up with a winner-takes-all scenario…. Ultimately, over time, you could see some players exiting the market, or starting to see some of the big players exit. The hope [in the beginning] was to have an array of manufacturers be able to create this competitive market but now it’s like we’ve gone to the other extreme,” Pietryga explained.

Salsi echoed this, stressing that policy makers should carefully consider the economic environment biosimilars require to thrive. Oskouei added that an education strategy is vital to ensuring all stakeholders—patients, providers, and policy makers—understand the value biosimilars bring.

The session concluded with a call for collaborative action. Pietryga emphasized a united industry approach to overcome market challenges. Salsi reiterated the need for a robust reimbursement model and ongoing education, while Oskouei advocated for innovation and comprehensive educational efforts to bridge gaps in understanding. With continued dedication to these goals, biosimilars are positioned to make high-quality, affordable therapies more accessible, ultimately contributing to a sustainable health care future.

Oskouei concluded with a look toward the future: “It's a ‘circle of biological life’ that biosimilars enable, so you bring healthy competition, lower costs, and ensure the accessibility of critical biologics. But equally important and equally exciting to me is reusing savings realized from biosimilars to invest in the next generation of innovation. So, we can move away from supportive care to disease-modifying treatments to more curative treatments that are better than everything we have available to us today.”

1. Burton C, Oskouei S, Pietryga M, Salsi J. Biosimilars market leaders discussion. Presented at: GRx+Biosims; October 21-23, 2024; Rockville, MD.

2. Jeremias S. FDA approves first denosumab biosimilars. The Center for Biosimilars

. March 5, 2024. Accessed October 31, 2024. 

https://www.centerforbiosimilars.com/view/fda-approves-first-denosumab-biosimilar

3. Jeremias S. FDA approves first Eylea biosimilars. The Center for Biosimilars. May 20, 2024. Accessed October 31, 2024. 

https://www.centerforbiosimilars.com/view/fda-approves-first-eylea-biosimilars

By expanding educational initiatives to clarify biosimilar safety, efficacy, and interchangeability, stakeholders can foster trust, improve access, and ensure that biosimilars are widely accepted as high-quality, cost-effective alternatives to originator biologics.

Conference

Panelists Stress Stakeholder Education to Build Confidence in Biosimilars

During a fireside chat at GRx+Biosims, FDA Commissioner Robert Califf, MD, shared his perspective on key challenges and sustainability concerns in the generic drug industry, touching on pressing issues within the US health care system and broader global supply chain vulnerabilities.

“We need to have a much more robust system to continue to learn and employ, in the complex bioscience space, the supportive elements from the clinical, real-world ethics studies. It’s been very important in helping the clinical world see that [generics and biosimilars] are okay,” Califf said.

The conversation was moderated by David Gaugh, RPh, executive vice president of the Association for Accessible Medicines (AAM). The AAM’s 

 was held from October 21 to October 23, 2024, in Rockville, Maryland.

Emphasizing the influence of financialization on health care, Califf described how complex financial incentives, and the concentration of resources negatively affect the resilience of the system. He noted the vulnerability exposed by recent hurricanes, highlighting how such events disrupt critical supplies and underscore the need for a fair pricing structure that sustains the industry. Califf stressed that ensuring high quality in generic drugs requires the government to play an active role in enforcing purchasing criteria based on quality.

On the topic of global supply chain vulnerabilities, Califf addressed the risks associated with the concentrating production of a product to a single location, especially in light of the devastation seen in the Asheville, North Carolina, area after Hurricane Helene hit in September 2024.

 The storm led to the closing of a factory in nearby Marion, North Carolina that served as one of the largest suppliers of intravenous fluids in the country.

 Califf questioned the wisdom behind having a single factory be the main supplier of a particular medical device for the whole country in the first place, especially as unexpected weather events as a result of climate change become more commonplace.

He emphasized the need for government access to supply chain data to help prevent crises and improve coordination, drawing a comparison to the way financial data is managed. Califf also criticized the biopharmaceutical industry's resistance to sharing this vital data, advocating for a more collaborative approach to ensure better preparedness and resilience.

“There's too much at stake if something goes wrong, and it shouldn't have to be that we're scrambling around on the telephone to figure out who else is making certain quantities of supply. But the industry has opposed us getting the information we need with their [lobbying organizations]. And I think that's a really irresponsible approach,” he stated.

Califf also highlighted the potential of artificial intelligence (AI) in improving public health, particularly in supply chain management. He advocated for AI's role in monitoring supply chain integrity and identifying dishonest practices, highlighting efforts the FDA is doing to incorporate these tools into drug application reviews.

“You apply AI for a [drug] application, you’ll find out when people are cheating. And if you’ve cheated in the past, watch out, because it's going to be easy to apply AI…." Califf warned. "I don't like being a cop, I don’t have much insight in developing influence, but I also don't like people who cheat. The system is very dependent on the integrity of the industry, so if you're cheating now, we're going to be applying the AI to you."

Alongside AI, Califf discussed user fees' role in funding FDA activities, noting that they provide strategic insight into future demands while enabling more disciplined operations.

Addressing the future of the generic drug industry, Califf stressed the importance of its role in providing affordable, high-quality treatments for chronic diseases, with a growing global demand for these medicines. He underscored the need for expanded production capacity in diverse locations, adherence to stringent quality systems, and investment in scientific advancement to uphold drug integrity. Concluding with advice for industry stakeholders, Califf emphasized the importance of conducting clinical studies through reputable organizations, fostering honesty, integrity, and collaboration to strengthen the industry's impact on global health. He extended gratitude to the industry for its ongoing efforts and reaffirmed the value of transparency and partnership in advancing public health goals.

“Most of the highly effective drugs have a generic now. As you develop more biosimilars for more users at a lower price, that’ll be a big needle push. So, for the 340 million people in the US, the generic drug industry is robust, but the growth potential worldwide for high quality generics [and biosimilars] is profound, and I think it's one of the most important aspects of public health."

1. Califf R, Gaugh D. Fireside chat with FDA Commissioner. Presented at: GRx+Biosims; October 21-23, 2024; Rockville, Maryland.

2. Reback S. Hurricane Helene: a disaster no one saw coming. The Assembly. October 1, 2024. Accessed October 25, 2024. 

https://www.theassemblync.com/essays/hurricane-helene-disaster-asheville/

3. Lupkin S. Storm damage closes N.C. factory that makes vital hospital supplies. NPR. October 4, 2024. Accessed October 25, 2024. 

At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, stressed the urgent need for data transparency in the global supply chain and the role of collaboration and artificial intelligence in ensuring the resilience of biosimilar and generic drug production.

Allison Inserro

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