FDA / FTC Workshop On A Competitive Marketplace For .

FDA/FTC WORKSHOP ON A COMPETITIVEMARKETPLACE FOR BIOSIMILARSMarch 9, 2020Page 13Page 151 one, to discuss the FDA's and FTC's collaborative1 adoption of both biosimilar and interchangeable2 efforts concerning the biologics marketplace in2 products.3 biosimilars. For those of us who believe in the34 marketplace, it's really important that the free4 a scientific organization at FDA, we are working to5 market work well, and that includes making sure, as5 support innovation and advance the scientific6 my predecessor Dr. Gottlieb had said before, that6 development of these groundbreaking products.7 there are no shenanigans. It's a really important7 We're also engaged in very close participation, our8 concept, and work together trying to address that8 partnership with FTC, in activities designed to9 issue.9 help ensure that healthcare professionals and10We believe that getting more biosimilars,On the scientific end, and we are very much10 patients receive truthful and non-misleading11 and hopefully interchangeables, on the market will11 information about biological products and to deter12 offer great potential and have a positive effect on12 anticompetitive behaviors in the marketplace13 the American public, both from an availability13 related to them.14 point of view but also from a cost point of view.1415Last month, as you know, we signed a jointI came to this job as a provider of cancer15 care. I can't tell you how important it is that we16 statement on our collaboration, which outlined our16 communicate with patients and providers about this17 shared goals and objectives and discussed how our17 and give them the most accurate information. That18 agencies will work together to support competitive18 will go a long way to ensuring that these products19 markets for biological products. This truly is an19 are available to the American public and providers.20 example of the U.S. government in a transagency20 What these activities have in common is the goal of21 fashion working together. It also described key21 helping to reduce costs and enhance patient access22 steps we intend to take to address false or22 to these important and potentially life-savingPage 14Page 161 misleading communication by biological product1 products.2 manufacturers. This is not meant to be an us23 versus them situation, but just so that everyone is3 of the best examples we have today of the potential4 on the same level working field and moving forward4 offered by unprecedented advances in medical5 to provide as much transparent information as5 science. What we're seeing across the world, and6 possible to developers and the American public.6 particularly in the United States, is7We've also released a draft guidance forThe development of biologics offers us one7 unprecedented, and we are very much interested in8 industry called Promotional Labeling and8 bringing science innovation to the patient bedside9 Advertising Considerations for Prescription9 for providers and patients alike.10 Biological Reference and Biosimilar Products:1011 Questions and Answers. That's a mouthful but11 through biotechnology in a living system, are used12 really important information contained in that12 to diagnose, prevent, treat, and cure diseases and13 draft guidance. We're expecting to get comments on13 medical conditions. We've seen enormous progress14 that, and we'll work with our partners around that,14 in this field in a relatively short period of time.15 and today we're holding this workshop, the next15 We're all working to catch up with that amazing16 important step in our collaboration.16 acceleration of innovation, and these products are17What the partnership of our two agenciesThese products, which may be produced17 increasingly playing a central role in the18 means is that our combined extensive resources and18 treatment of the many serious and life-threatening19 efforts in this area can have a dual focus on both19 diseases. In fact, in some situations, these are20 the scientific and the legal fronts. This means we20 the only products available to treat patients with21 will do everything possible to support a robust21 life-threatening situations.22 market place for biological products, including the22Min-U-Script So there's an urgent unmet medical need forA Matter of Record(301) 890-4188(4) Pages 13 - 16

FDA/FTC WORKSHOP ON A COMPETITIVEMARKETPLACE FOR BIOSIMILARSMarch 9, 2020Page 17Page 191 us to do as much as we can in this sphere, and that1 for the American public, again, with choice and2 will likely continue to grow, and we certainly hope2 competition. We've taken Congress' goal to heart3 it does grow. Last year, we approved3 and are doing everything, particularly with our4 10 biosimilars. That makes a total since 2015 of4 great partners at FTC, to increase accessibility5 26 for 9 different related reference products; and5 and help Americans realize the promise of6 in the early months of 2020, we have continued to6 biosimilars.7 see strong momentum. Congress recognized this78 promise 10 years ago, and to support it, passed the8 strides, but we have more work to do, and we9 Biologics Competition and Innovation Act.9 realize that, and we're always looking for ways to10Just as a brief moment here, we know fromWe're already making some significant10 improve. We've improved the efficiency of the11 the generic space, the prescription side, the drug11 biosimilar and interchangeable product development12 side, that the more generics we have12 approval process.13 available -- and I'm making a relationship between1314 generics and biosimilars, and I realize the14 How do we make it more efficient? How do we make15 translation isn't a hundred percent correct. But15 it easier for developers to provide the information16 we know when we introduce generics on the drug side16 to us? How do we on our end make it easier for our17 that we significantly reduce costs, so let me give17 reviewers so that the number of review cycles goes18 you a few facts about this.18 down and the process and the timeline for approval19If one generic is introduced to a referenceAcross the agency we're looking at this.19 goes down as well?20 product, on average, that reduces the price of that2021 product by about 35-36 percent. If we introduce up21 safety and efficacy, but we definitely want toWe are maintaining our gold standard of22 to 6 generics in a product space, that can reduce22 maximize efficiency and want to provide as muchPage 18Page 201 the price of those products by as much as1 regulatory clarity for developers as possible.2 95 percent. We're hoping to get the same sort of2 We're also doing our best to try to strengthen3 scale and approach in the biosimilar and certainly3 effective communications with the American public,4 in the interchangeable space. The more we can do4 providers, and with innovators.5 in this area, the better it's going to be for56 competition and choice for the American people.6 partnership with FTC, and I want to focus on that7We think, and our estimates are, that overThe last point has special relevance for our7 for a moment. We know that a free market, as I8 the last decade, competition in the generic space8 mentioned before, and enhanced competition supports9 has saved Americans in the healthcare system more9 increased innovation, so it has the virtuous effect10 than a trillion dollars, and we need to get working10 of not only helping in terms of decreasing prices11 to have this occur in the biosimilar space and11 as we've seen on the generic side, but also12 interchangeable space as well.12 stimulating further innovation. But for it to be a13Biologics account for a disproportionate13 free market and a fair market, it has to absolutely14 amount of the overall spending of prescription14 be free.15 drugs. They're 2 percent of the total of1516 prescription drugs but account for, by our16 the development of the biologics market, there have17 estimates, 40 percent of the cost of prescription17 been obstacles to increase competition. That's not18 drugs.18 okay. We've seen efforts by manufacturers to delay19Where we are right now is where we wereUnfortunately, since the earliest stages of19 competition for biosimilar products and we've seen20 before in the prescription drug side of the house20 the publication of materials that seem designed to21 and, again, the more we do work on the biosimilar21 create uncertainty about biosimilars and discourage22 interchangeable side, the better it's going to be22 patients and healthcare providers from using them.Min-U-Script A Matter of Record(301) 890-4188(5) Pages 17 - 20

FDA/FTC WORKSHOP ON A COMPETITIVEMARKETPLACE FOR BIOSIMILARSMarch 9, 2020Page 211These behaviors have the potential to putPage 231Thank you for your service to the American2 innovation at risk, erode public confidence in the2 people, including on biologics and biosimilars.3 product, weaken efforts to lower healthcare costs3 Just in our brief conversation, I know you feel so4 through competition, and ultimately undermine4 passionate about this subject. Prior to her5 advances in healthcare, as potential treatments and5 position as chief of staff, Ms. Koslov was acting6 cures are unavailable or go unrealized. At FDA, as6 director of the Office of Policy Planning. She is7 at FTC, we are very committed to empowering the7 a graduate of Harvard Law and Brown University.8 American consumer and the American provider, and we89 must do more in that area.9 you.10To counter these activities, we've taken a10Ladies and gentlemen, Tara Koslov. Thank(Applause.)11 number of actions from the creation of the1112 biosimilar product development program to a public1213 education campaign that you all know about.13 delighted to join Commissioner Hahn in welcoming14Our collaboration with the FTC is the nextOpening Remarks - Tara KoslovMS. KOSLOV: Good morning, everyone. I'm14 you all here today, and on behalf of FTC, Chairman15 step in our efforts to end these types of15 Simon, he truly regrets not being able to be here16 counter-productive activities; and, Tara, I want to16 with us today, which is why you get me instead.17 thank you and Commissioner Simons for the terrific17 But as Commissioner Hahn mentioned, I have long18 work that you've done in partnership with us. It18 worked on these issues, and I am indeed passionate19 will help and support and ensure an environment in19 about them. So I'm pleased to be here representing20 which biosimilars can fulfill their promise and20 my agency.21 reach the patients who need them because the market2122 is a competitive and fair one.22 workshop is part of the decades-long collaborationLet me begin with a few thank yous. ThisPage 221The FDA, as I mentioned, is a science-basedPage 241 between the Federal Trade Commission and the FDA to2 organization and data-driven, and our work is2 promote competitive markets for pharmaceuticals.3 premised on the understanding that decisions must3 Today, our focus is on biologics markets and what4 be based on good data and sound science. In this4 can be done to spark competition for these5 way, we can promote innovation and support the5 innovative new treatments.6 development of new treatments and cures. But this67 activity must be conducted on a fair playing field7 Commissioner Scott Gottlieb for initiating this8 that the patients and our public and our providers8 joint agency effort and Commissioner Hahn for9 depend upon.9 continuing it. I would also like to thank the FDAI would like to thank former FDAOur collaboration with FTC, as I've10 for hosting this workshop and the many FDA and FTC11 mentioned, is designed to help ensure this, and I11 staff who made this workshop happen. An incredible12 very much want to congratulate FTC in all they've12 amount of work went into planning and executing13 done. Today's meeting, as I mentioned, is that13 this event. As someone who has done plenty of14 next step and, again, really appreciate the14 events at the FTC, I know exactly what goes into15 partnership with FTC.15 putting together something like this, and I'm very1016So on that note, it's my great pleasure to16 grateful for everyone's efforts.17 introduce the chief of staff of FTC, Tara Koslov.1718 Ms. Koslov has served as Chairman Simon's chief of18 treatments for serious and life-threatening19 staff since he was sworn in as chairman of FTC on19 diseases like cancer, diabetes, and Crohn's20 May 1, 2018. She has worked on healthcare20 disease. Often biologics are the only effective21 competition matters throughout her 23-year career21 treatments for these diseases, but biologics can be22 at FTC. That's really impressive staying power.22 very expensive, some costing tens of thousands andMin-U-Script Biologics, as we all know, our innovativeA Matter of Record(301) 890-4188(6) Pages 21 - 24

FDA/FTC WORKSHOP ON A COMPETITIVEMARKETPLACE FOR BIOSIMILARSMarch 9, 2020Page 25Page 271 others costing millions of dollars. Total U.S.1 against brand and generic drug manufacturers2 spending on biologics is growing rapidly and2 seeking to gain the Hatch-Waxman process by3 reached 125.5 billion in 2018.3 entering into anticompetitive reverse payment4I'm going to provide the FTC's perspective4 agreements.5 as a competition and consumer protection56 enforcement agency. As many in this room already6 decision by the Supreme Court in FTC v. Actavis,7 know, the FTC has a broad mission to protect7 holding that such agreements can create antitrust8 consumers and promote competition by preventing8 liability. We've also seen favorable9 anticompetitive, deceptive, and unfair business9 interpretations of activists in other federal10 practices.11The agency's victories include a landmark10 courts and sweeping settlements that prevent majorBecause of the critical role competition11 manufacturers from entering into anticompetitive12 plays in reducing prices and fostering innovation,12 reverse payment agreements.13 the FTC has long been interested in promoting1314 competition in pharmaceutical markets.14 number of potentially anticompetitive reverse15One way the FTC does this is by conductingPerhaps as a result of these successes, the15 payment agreements has dropped precipitously.16 industry studies. More than 40 years ago, for1617 example, the FTC published a report on state laws17 also extends to the biologics industry. In fact,18 that prevented pharmacists from substituting18 the FTC brought its first enforcement action19 generics for branded drugs.19 involving a biologic almost 30 years ago. More20The FTC concluded that these laws imposedThe FTC's experience with pharmaceuticals20 recently, the FTC provided technical assistance as21 substantial unwarranted costs on consumers by21 Congress developed the abbreviated pathway for22 unduly restricting price competition between22 approval of biosimilars.Page 26Page 281 generic and branded drugs. These findings helped12 pave the way for now familiar state laws that allow2 for an abbreviated pathway, the House Committee on3 automatic substitution of a generic for the brand.3 Energy and Commerce requested, and the FTC4Similarly, a 2002 commission study onIn 2008 when Congress was weighing options4 provided, lessons learned from Hatch-Waxman to help5 generic drug entry recommended the brand name5 structure the new pathway, and in 2009, the FTC6 companies and generic applicants, settling patent6 testified before Congress about a follow-on7 litigation under the provisions of the Hatch-Waxman7 biologic drug competition to inform the debate on8 Act, should be required to submit those settlements8 the legislation that became the abbreviated9 to the FTC.9 pathway.10This recommendation was incorporated into10As an aside, the commissioner who provided11 the Medicare Modernization Act of 2003 and is now11 that testimony at the time was actually the12 the primary means by which the FTC learns about12 commissioner I was working for at the time as her13 potentially anticompetitive patent settlements13 attorney advisor, which shows you how far back my14 between brand and generic drug manufacturers.14 involvement goes in these issues. So it's kind of15 Following the 2018 amendments to the Medicare15 nice to come full circle.16 Modernization Act, the FTC now also obtains and1617 reviews patent settlement agreements involving17 biosimilars is just as important as competition18 biologics and biosimilars.18 between brand and generic small molecule drugs.19Another way the FTC promotes competition inCompetition between reference biologics and19 Biosimilars, which are as safe and effective as20 pharmaceutical markets is by vigorously combating20 their reference biologics, hold the promise of21 anticompetitive conduct. Notably, the commission21 reducing price, and therefore increasing access to22 has a long record of successful enforcement actions22 these treatments. This is because when given aMin-U-Script A Matter of Record(301) 890-4188(7) Pages 25 - 28

FDA/FTC WORKSHOP ON A COMPETITIVEMARKETPLACE FOR BIOSIMILARSMarch 9, 2020Page 29Page 311 choice between two highly similar products,12 well-informed consumers typically choose the less2 importance of the more than 65-year history of3 expensive option.3 collaboration between the FTC and the FDA. I4This competition in turn drives prices down,In closing, I want to reiterate the4 believe this collaboration has benefited American5 but competition only works when consumers have5 consumers in untold ways, but most concretely by6 reliable and truthful information. In some6 making safe and effective treatments more widely7 instances, statements from reference biologic7 available and at a lower price.8 manufacturers and the groups they fund may mislead89 patients and physicians into believing the9 thank the FDA for its critical support of the FTC'sOn behalf of Chairman Simon and the FTC, I10 biosimilar is not as safe or as effective as the10 investigations and industry studies, and we look11 reference biologic. Such deception might violate11 forward to continuing this legacy of collaboration.12 both consumer protection laws and antitrust laws.12 Thank you all for your time this morning. I'm sure13On the consumer protection front, while the13 you will all have a very productive and engaging14 FTC generally supports comparative advertising,14 day. Thanks.15 that advertising must be truthful and not15(Applause.)16 misleading. Advertising that creates an impression16MS. ANDRUS: Good morning. My name is17 of clinically meaningful differences between a17 Meredyth Andrus. I'm an attorney in the healthcare18 reference biologic and its biosimilar is likely18 division of the Bureau of Competition at the19 false or misleading, and therefore would constitute19 Federal Trade Commission. This first panel we put20 an unfair or deceptive practice.20 together are some experts in the field to discuss21Similarly from an antitrust perspective,21 the development and licensure of biologics and22 maintaining or growing share by deceiving patients22 biosimilars and the post-approval uptake process.Page 30Page 321 and physicians about competitors offerings is not12 competition on the merits. It also erects2 introduce themselves. The way we will conduct this3 artificial barriers to entry and creates costs for3 panel is there will be two brief presentations by4 biosimilar manufacturers who have to counter the4 Christine and by Eva, and then we will go through a5 deception. Such deception, therefore, likely would5 series of questions and answers that we have6 constitute an unfair method of competition.6 prepared. So without further ado, let's jump in7The FTC is committed to taking appropriateI'm going to let all of the panelists7 and let's do some introductions first.8 enforcement action against false or misleading8Surya?9 communications involving biologics and biosimilars,9DR. SINGH: Hi. Thank you for having me.10 but the FTC's enforcement priorities in this10 I'm Surya Singh. I'm an independent consultant, an11 industry extend beyond deceptive conduct. The FTC11 internist by training, and former chief medical12 will also seek to deter behavior that impedes12 officer of the Specialty Pharmacy at CVS/Aetna.13 access to samples needed to develop generics and13 I've been interested in these issues for a long14 biosimilars.14 time, so thanks again.15For example, just this past January, the FTC15MS. BURICH: Hi. Molly Burich, director of16 brought its first case alleging a restrictive16 public policy at Boehringer Ingelheim.17 distribution scheme that anticompetitively blocked1718 competition for a small molecule drug. The FTC18 executive director of the Biosimilars

Mar 09, 2020 · 10 FDA, Dr. Hahn has helped bring the FDA and FTC ; 11 This workshop is subject to FDA policy and : 11 joint statement to life, reinforcing the agency's ; 12 procedures for electronic media coverage. 12 commitments to taking key steps to reduce g