Life Science Compliance Update

December 19, 2016

The Uncertain Future of Biosimilars in the United States


Friends of Cancer Research held an event, “The Future of the U.S. Biosimilars Market: Development, Education, and Utilization,” on Tuesday, October 18, 2016. The event was a half-day forum that brought together clinicians, originator and biosimilar drug sponsors, advocates, regulators, and payers in an attempt to tackle uncertainty surrounding the future of the United States biosimilars market.


As we have written about before, the 2009 Biologics Price Competition and Innovation Act (BPCIA) created an abbreviated licensure pathway, 351(k), for biological products that are shown to be biosimilar to, or interchangeable with, an FDA-licensed reference originator product. The regulatory requirements for biosimilars are significantly greater than those for generic drugs as biologics are far more complex than small molecule drugs. In 2012, the FDA issued the Guidance, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product in 2012, and in 2015, the FDA released additional Biosimilarity Guidances. In 2015, the FDA approved Zarxio, the first biosimilar product submitted via the 351(k) pathway. However, questions still remain for the implementation of the biosimilar pathway in the United States, particularly for the development of monoclonal antibody (mAb). Several important biosimilar mAb therapeutics for treatment of autoimmune disorders and cancer are already in development or approved in other regions.

The discussion sponsored by FORC was divided into two panels, one on the regulatory landscape for biosimilar development and the other on clinical decision-making, coverage and reimbursement. Panelists represented a wide range of stakeholder interests, including biosimilar developers, the Food and Drug Administration (FDA), the patient community, benefit managers and payers, and professional societies.

Panel Discussion

During the first panel discussion, Dr. Leah Christl, Associate Director for Therapeutic Biologics at the FDA, noted that an interchangeability designation did not necessarily signify a higher standard than a biosimilar designation. Biosimilars are approved when they are shown to be “highly similar” with “no clinically meaningful difference” from the reference product, whereas interchangeability means that a prescription written for a biologic could be substituted at the pharmacist’s discretion for a drug that was therapeutically equivalent.

Dr. Christl believes that interchangeability will have large implications for manufacturers because it allows pharmacists the discretion to substitute one branded product for another. Dr. Carlos Sattler, Vice President and Health of Clinical Development and Medical Affairs at Sandoz, Inc., noted that a manufacturer’s decision to seek the interchangeability designation is more of a strategic decision, as it depends on the content of the additional information package required to be submitted to the FDA.

Audience members pointed out that two products that have clinical similarity and being able to demonstrate the safety of switching patients from one product to another during an ongoing course of treatment are two very different things. They expressed concern about switching patients, patient access to drugs, and continued cost restrictions.

During the second panel, Jeff Eichholz, the Senior Director of Drug Trends Solutions at Express Scripts, stated that biosimilars do have the ability to introduce high savings to patients, but it is extraordinarily important for patients to be able to maintain access to their original product if switching is not appropriate for their course of treatment.  

The panel also discussed CMS’ decision to group biosimilars paid for by Medicare Part B under the same billing code. Dr. Eichholz finds that approach to be a step in the right direction, but that there are concerns when the average price for one drug in the group was much different than others.

All panelists emphasized the importance of keeping biosimilars distinct for data tracking purposes about their long-term impacts, as well as the importance of patient access, especially for patients who were started on a specific product. Even still, despite the challenges for the future of the biosimilar market, all panelists and stakeholders still remain optimistic about the ability of biosimilars to bring down costs, while maintaining access for patients.

June 30, 2016

Alliance for Health Reform Holds Biosimilar Panel

The Alliance for Health Reform recently held a briefing on biologic drugs and the emerging market for biosimilar products in the United States. The briefing allowed for a discussion of regulatory and policy questions that continue as the Food and Drug Administration (FDA) continues to review and approve applications for biosimilars. As of right now, the FDA has approved two biosimilars, but only one of those two approvals is available on the market.

The panel discussion included experts such as: Leah Christl, the associate director for therapeutic biologics at the FDA; Barbara Finck, the chief medical officer at Coherus Biosciences; Brian Lehman, the manager of pharmacy benefits and policy at the Ohio Public Employees Retirement System (OPERS); Leigh Purvis, director of health services research at AARP; and Angus Worthing, rheumatologist and member of ACR Government Affairs Committee, American College of Rheumatology.

Panelists represented a wide range of stakeholders and throughout the discussion, panelists talked about public acceptance of biosimilars, the costs of biosimilars (as well as potential for savings), and lingering regulatory issues such as standards for interchangeability and non-proprietary naming requirements.

Discussion Points

Interchangeability Standard

Leah Christl discussed what type of data will be necessary to demonstrate a biosimilar's interchangeability with its reference product. She noted that we are dealing with uncharted waters here, as the United States is the only country to actually differentiate between biosimilarity and interchangeability. She stated that interchangeability is a different standard, but not necessarily a higher standard. She, however, stopped short of giving specific data elements that will be required, noting that no guidance has yet been published.

She offered the suggestion to look to the statute, to see the types of information that might be necessary. She further noted that the information did not have to necessarily be clinical data, and can include elements from post-market analysis. The agency will consider the "totality" of the circumstances, avoiding a "one size fits all" approach.

FDA Regulatory Efforts

While it may seem like it is taking a long time for the FDA to do much of anything about biosimilars, it is important to remember that there are several pieces to the puzzle that need to be put together. According to Dr. Worthing, full transparency is key: it will allow patients to know what they are taking and will provide physicians with the information they need to know about what they're prescribing. He believes that "this can be accomplished by using distinct names for biosimilars, having clear information on FDA drug labels, and implementing consumer-oriented pharmacy dispensing practices."

Biosimilar Development

Barbara Finck spoke on biosimilar development, acknowledging that biosimilars have the same amino acid "backbone" as their reference drug, but as they are made of living cells, they have small differences as a result of manufacturing. Dr. Finck equated it to an expert forger making copies of the Mona Lisa, each copy would be very good, but there would still be small differences between the copy and the original; Dr. Christl equated it to brewing beer: the fermentation process can render each batch slightly different that the one before it, even though they always start with the same ingredients.

Public Acceptance of Biosimilars

The panelists generally discussed how important it is for the biosimilar market to be thriving: Leigh Purvis noted that it may be important for patients to fully understand that there is nothing to fear about biosimilars, and that they would (on average) save patients 25% to 30% as opposed to the reference product. Biosimilars, therefore, may be a solution to the contentious drug pricing topic frequently discussed these days.

Dr. Finck also agreed that biosimilars are safe and effective: she referenced stringent FDA statistical standards and the European experience. Biologics and biosimilars are expected to be covered under Part D.


In the end, Dr. Worthing noted, "It's easy to get lost in the weeds of regulatory issues, but biosimilars naming, labeling and interchangeability issues have real and profound safety and health consequences for patients."

June 08, 2016

FDA Announces Information Collection Regarding Biosimilar Suffixes

The Food and Drug Administration (FDA) has announced an information collection seeking sponsors of past and present biologic applications submit a proposed suffix composed of four lowercase letters for use as the distinguishing identifier included in the name designated by the FDA.

The information collection is pursuant to FDA biologics naming guidance issued in August 2015, "Guidance for Industry on Nonproprietary Naming of Biologic Products." The guidance outlines the FDA's intention for biologics to "designate a nonproprietary name that includes a core name and a distinguishing suffix," this information collection seeks proposed four letter suffixes from sponsors of biological product applications.

The guidance included information collection by requesting that applicants propose a suffix composed of four lowercase letters for use as the distinguishing identifier included in the proper name designated by the FDA at the time of licensure for biological products licensed under the Public Health Service Act. The guidance recommended that applicants submit up to 10 proposed suffixes, in the order of the applicant's preference, in addition to including supporting analyses demonstrating that the proposed suffixes met the factors described in the guidance.

The FDA estimated that they will receive a total of forty requests annually for the proposed proper name for biological products submitted under section 351(a) of the PHS Act, and 6 requests annually for the proposed proper name for biosimilar products and interchangeable products submitted under section 351(k) of the PHS Act.

Previous Response

There were a variety of responses submitted in response to an August 2015 Federal Register notice requesting public comment on the proposed collection of information. According to the FDA, most comments were supportive of the proposal to designate a suffix. Many suggested that a meaningful, distinguishable suffix may help to improve pharmacovigilance, enhance safety, and facilitate identification between biological products. Some comments supported the use of a random suffix to avoid creating an unfair advantage for specific manufacturers. One comment, however, noted that the FDA's estimate of six hours to submit proposed suffixes, which was supposedly based on the FDA's experience, is based only on the time needed to prepare the submission itself after multiple suffixes have been selected. The comment went on to note that because the FDA suggests that each respondent submit three suggested suffixes for consideration, the time needed to do an analysis of each suffix would exceed 720 hours per suffix or 2,160 hours total for the three suffixes, based on their own company experience.

The FDA believes those figures to be high and retain their original estimate of 6 hours, which is based on their familiarity with the average amount of time required by similar submissions to the FDA. The FDA does, however, revise their estimate upward to account for burdens associated with creating and submitting up to ten proposed suffixes for designation.

Industry Request and Opinion

This information collection follows a recent request by seventy different nonprofits and stakeholders, spearheaded by the Alliance for Safe Biologics, that the FDA use meaningful suffixes for biosimilar non-proprietary names, such as the one used with the first biosimilar approval for Zarxio. The group believes that meaningful suffixes are preferable to the random suffixes that are described in the aforementioned draft guidance, and what the agency used for its second approval for Inflectra.

The Alliance for Safe Biologics and other groups sent a letter to Leah Christi, Ph.D., associate director of therapeutic biologics and biosimilars at the FDA, saying, "Meaningful suffixes are easier for patients, providers and pharmacists to both recognize and remember, thus facilitating accurate association between adverse events and specific products." The group also noted that a survey of 400 biologic prescribers suggested they prefer meaningful suffixes over random by a six to one margin, while a survey of 401 United States pharmacists showed a preference for manufacturer-based suffixes over random.

The Biosimilars Forum, BIO and Pharmaceutical Research and Manufacturers of America (PhRMA) have also previously called for the FDA to use "meaningful" and "distinguishable" suffixes linked to the license holder's name.

Comment Submission

Comments on the information collection are due thirty days following publication and may be submitted via fax or email to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: (202) 395-7285, email: All comments should be identified with the OMB control number 0910-NEW and title, "Nonproprietary Naming of Biological Products." Docket No. FDA-2013-D-1543 should also be referenced.


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