United States: FTC Workshop Seeks To Spark Biosimilars Competition

Demand for biologics is growing fast, but even after Congress passed authorizing legislation in 2010, the pace of generic entry appears to have stalled. Seeking to spur increased generic competition, the FTC held an all-day workshop earlier this week to discuss evolving FDA and state regulations, especially on the key issues of substitutability and naming rules for follow-on biologics. While the workshop participants did not reach consensus, the debate was lively and provided much for the FTC to consider as it continues to examine and weigh in on the topic.

FTC Returns to the Follow-on Biologics Debate

Nearly five years have passed since the FTC issued its 2009 report on the potential for increased competition in the "follow-on" biologics marketplace.1 Since that time, Congress has passed a key piece of enabling legislation, the 2010 Biologics Price Competition and Innovation Act (BPCIA), which incorporates many of the FTC's recommendations.2 The BPCIA is an attempt to create a viable marketplace for generic or "follow-on" biologic drugs, akin to the one created for traditional small-molecule generic drugs by the Hatch-Waxman Act of 1984.3 The BPCIA authorizes the FDA to create a "fast track" for approving follow-on biologics as either "interchangeable" (identical in effect to the reference drug) or "biosimilar" ("highly similar" to the reference drug, with "no clinically meaningful differences [in] safety, purity, and potency")4.

Despite the passage of the BPCIA, however, efforts to generate meaningful generic competition in the biologic drug space appear to have stalled. To try to address this issue, the FTC convened a workshop on February 4, 2014 to discuss how best to stimulate competition.5

The day-long event opened with remarks from Chairwoman Ramirez that highlighted the FTC's commitment to creating a viable and competitive follow-on biologics marketplace, and featured a diverse group of participants, including representatives from manufacturers of both pioneer and follow-on biologics, insurance, pharmacy and pharmacy benefit management companies, as well as consultants, consumer advocates, academics, and other industry experts.

A Fast-Growing Category of Drugs, But Slow Progress towards Generic Approval

Developed over the last thirty years, biologics are a fast-growing category of drugs that are protein-based and derived from living matter or manufactured in living cells. In contrast to so-called "small-molecule" drugs, which are manufactured using standardized chemical processes, biologics are extremely challenging to manufacture, and are almost impossible to replicate precisely without access to proprietary information from the pioneer manufacturer. These difficulties, combined with the lack of a clear regulatory pathway to market, have hindered the development of a follow-on biologic drug industry in the United States.

Although the United States approved a handful of follow-on biologics under the Food Drug & Cosmetic Act prior to the passage of the BPCIA,6 no new follow-on biologic drugs have been brought to market in the United States in years and the approval process and marketplace remain underdeveloped. Despite the FDA's issuance of limited draft guidance related to implementing the BPCIA in February 2012 and the filing of a number of follow-on biologic approval applications by drugmakers, multiple key elements of the pathway to follow-on biologic approval remain unresolved. Key open questions include bioequivalence standards, substitutability, and naming conventions.

The View from Abroad

A recurring theme at the workshop was the slow pace of progress in the US follow-on biologics marketplace, in contrast with other jurisdictions which have more vibrant follow-on biologics marketplaces. The EU in particular was cited by many experts as an example of a successful regulatory regime, with more than a dozen biosimilars having been granted approval since the enactment of enabling regulations in 2003.7 Japan and Australia were also noted as having developed successful regulatory regimes, with Japan having approved its first biosimilar in 2009 and Australia in 2010. But, the panelists drew contrasting lessons from the different experiences, particularly regarding the naming issues discussed below.

State Law, a Potential Obstacle to Biosimilar Substitution

While US federal regulation appears to be progressing, albeit slowly, state-level developments have emerged that threaten to block or severely delay the creation of a viable follow-on biologics marketplace. Urged on by the manufacturers of pioneer biologic medicines, multiple state legislatures have either considered or enacted bills that would limit the ability of pharmacies to substitute biosimilars for brand-name biologics.8 While this movement has not yet spread nationwide, consumer advocates have noted that it runs counter to the current practice of permitting automatic substitution of therapeutically equivalent generic medication at the pharmacy level, as is permitted by law in most states for small- molecule generics, and would tend to thwart the intent of the BPCIA, which explicitly provides for automatic substitution for follow-on products approved as interchangeable.

In 2013, 18 states introduced 28 separate bills purporting to regulate the substitution of follow-on biologics. Many of these bills included the requirement that pharmacists report the substitution of any biologic to the prescribing doctor and keep separate records detailing substitution choices for a fixed period of time. Panelists weighed in on these proposals, especially with regard to whether they are likely to restrict competition more than necessary to achieve consumer safety.

During a heated discussion, some representatives pointed to the persistent differences between pioneer biologic drugs and their biosimilar counterparts as evidence that biosimilars should be separately tracked, while others, particularly follow-on biologic manufacturers and consumer advocates, argued that requiring separate tracking and reporting would unnecessarily burden doctors and pharmacists and would stoke unfounded public fears about the perceived safety and quality of follow-on biologics. Panelists from consumer groups also emphasized that such laws are premature, since the FDA process for certifying interchangeable biologics has not yet been established, and that they appear to be a back-door attempt to undermine the creation of a true interchangeable marketplace. Given that the BPCIA explicitly authorizes the designation of interchangeable drugs – which the Hatch-Waxman Act does not – consumer advocates argued forcefully that such attempts to place obstacles in the way of interchangeability run directly counter to the purpose of the law.

Naming Issues, an Additional Complicating Factor for Biosimilars

Finally, the FTC workshop addressed the impact of naming conventions for biosimilar pharmaceuticals. Pioneer drugmakers long have argued that for reasons of consumer safety and drug origin traceability, follow-on biologics should not be marketed under the same non-proprietary name (equivalent to the active pharmaceutical ingredient for non- biologics) as their pioneer biologic counterparts. Others, including consumer advocates and follow-on biologics manufacturers, have countered that using multiple names likely would hinder substitutability and discourage customer adoption of cheaper, therapeutically equivalent generic products. Several participants noted that there is inherent variability with biologics — e.g., detectable variations may exist even among batches produced by the pioneer manufacturer — raising concerns that follow-on biologics may not be sufficiently identical to the reference drug to warrant using the same non-proprietary name.

The FTC staff posed two key questions to the panelists: whether unique names for follow-on biologics would meaningfully improve patient safety, and whether any such advantages would be outweighed by the tendency of multiple names for similar drugs to hinder substitution and therefore competition. Participants from companies that manufacture pioneer biologics argued that requiring follow-on biologics (both biosimilar and interchangeable) to carry a unique non- proprietary name would avoid confusion over which drug was actually dispensed, improve adverse event reporting efforts and prevent issues with one drug manufacturer from being misattributed to another, while still allowing drugs to compete fairly based on their individual reputations. As further support, some pointed to the European Medicines Agency's recent mandate that all biosimilars be marketed under distinct brand names because of concerns over misattribution of adverse event reports concerns. Follow-on biologic manufacturers and consumer and payor groups countered that drugs that are certified as clinically substitutable by the FDA should share a common non-proprietary name, as is currently done with small-molecule drugs, and that to do otherwise would breed confusion at the provider level and inappropriately diminish adoption of qualified generic substitutes. Some of these participants pointed to evidence from Australia and Japan, which have required the use of unique non-proprietary names for biosimilars, to support their position that such requirements drive down biosimilar adoption and reduce competition to the detriment of consumers.

Conclusion: FTC Likely to be Active in the Biosimilar Marketplace

In her opening remarks, Chairwoman Ramirez lauded the FTC's key role in fighting against state anti-substitution laws in the 1970s and in favor of the development of a true follow-on biologic marketplace in the lead-up to the passage of the BPCIA. Citing generic competition as a crucial resource for reducing costs to consumers, the Chairwoman expressed optimism about the ability of the Commission to continue to work with stakeholders to deliver the benefits of biologics at affordable prices. While consensus on the appropriate next steps remained elusive at the workshop, the high level of discussion and clear commitment of Commission staff to the issues leaves little doubt that the FTC will continue to advocate for greater transparency and competition in this fast-growing and challenging field.

Footnotes

1 See Federal Trade Commission, Emerging Health Care Issues: Follow-on Biologic Drug Competition (Jun. 11, 2009) ("2009 Report").

2 42 U.S.C. §262 et seq.

3 21 U.S.C. §301 et seq.

4 42 U.S.C. §262(i)(2).

5 The FTC will accept written public comments through March 1, 2014.

6 See 2009 Report at pg. 4 n. 5.

7 See Press Release, European Medicines Agency, European Medicines Agency Recommends Approval of First Two Monocolonal Antibody Biosimilars (Jun. 28, 2013), available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/06/news_detail_001837.jsp&mid=WC0b01ac058004d5c1.

8 See Andrew Pollack, Biotech Firms, Billions at Risk, Lobby States to Limit Generics, New York Times, Jan. 28, 2013, available at http://www.nytimes.com/2013/01/29/business/battle-in-states-on-generic-copies-of-biotech-drugs.html?hpw&_r=1&.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Similar Articles
Relevancy Powered by MondaqAI
Hunton Andrews Kurth LLP
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Hunton Andrews Kurth LLP
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions