United States: Biosimilars In The US: Hurdles To Progress

This client alert is the third of a three-part series that discusses hot topics to come out of the 2015 BIO International Convention.

During the BIO 2015 Convention in Philadelphia, there were several sessions directed to biosimilars. Biologic medicines now account for about one-third of annual drug approvals in the US (according to the Pharmaceutical Research and Manufacturers of America) and it is estimated that in the next year or two, 80 percent of the top-selling medicines will be biologics. One panelist, stated that, in the biosimilar world, structure determines everything. It is one of the reasons the quality of the structure determinations and the similarity of the structure of the biosimilar candidate to the innovator reference product is emphasized. The biosimilar must be highly similar in structure and must function the same way. According to another panelist, quality data on the structure and function of the biosimilar are needed to show similarity, and clinical trials confirm biosimilarity.

Many of the panelists stated that the lack of clarity in regulations is one of the major roadblocks to advancing biosimilars.  A concern is that existing statutes regulating "generic drugs" could be applied incorrectly to biosimilars.  This has led to a recent move to amend state laws to address biologics and biosimilars. More than 30 states have at least considered legislation establishing state standards for biosimilars.  Among the topics being addressed are labeling, dispensing and substituting a biosimilar to replace the innovator biologic product.  Issues regarding switching (done by the physician) versus substitution (done by a pharmacist), prescriber notification of any substitution, patient notification that a switch or substitute has been made, and whether a biosimilar must be approved as "interchangeable" by the FDA before it can be substituted for the innovator biologic medicine are among the hot topics being discussed in state legislatures.  No other global regulatory agency makes a distinction between biosimilarity and interchangeability.

In the US, a biosimilar would be considered interchangeable if, for the same clinical purpose as an innovator product, it can be switched back and forth without any significant change in efficacy and be expected to produce the same clinical result as the innovator reference product in any given patient.  Such interchangeability is similar to that  expected for generics of name-brand prescription medicines.  What stands in the way of this goal are difficulties in determining similarity, and the herculean task of developing state and federal regulations for this growing field of medicine.  So far, the FDA has not issued specific recommendations on interchangeability.  The FDA has said that interchangeability is considered a higher standard than biosimilarity, and indicated a preferred approach is for a company to first prove "biosimilarity" before requesting an "interchangeability" designation.

In international emerging markets, there are additional challenges.  In some international markets that have not adopted regulations for biosimilars, biosimilar products are inaccurately labelled as "generic" drugs.  As part of its mandate to establish and promote international standards with respect to pharmaceutical products, the World Health Organization (WHO) has published advisory guidelines for regulating and evaluating biosimilars by international regulatory authorities.  Unlike the FDA, the WHO is not a regulatory authority, and has no enforcement authority in member states.  One panelist, a medical doctor, stated that, to increase adoption of international standards by member states, the WHO collaborates with other agencies, including the Asia Pacific Economic Cooperation (APEC) and the International Pharmaceutical Regulators Forum, to promote and develop international standards.  The FDA is following some of the WHO guidelines regarding biosimilars.  The WHO also participates in regional workshops to support regulators and manufacturers in emerging markets.  The next workshop will occur in September 2015 in Ghana.

As the industry and state, federal and international governments strive to support this new field of medicine, a number of questions still need to be answered.  How similar must a biosimilar be in order to be highly similar?  Is automatic substitution appropriate for biological medicines, or should substitution occur only under the direct supervision and with the consent of the treating physician?  Should biologics be prescribed only by brand name to avoid automatic substitution?  How can we avoid any stigma or adverse message being sent to pharmacists and patients that substitutions are somehow not as good as the innovator biologic?  How fast will state legislatures be able to update their pharmacy practice acts to allow for substitution of interchangeable biologic products?  How can industry work with state, federal and international regulators to promote the growth of this new frontier in medicine?

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.

In association with
Related Topics
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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.


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.


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