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ASBM Releases Pharmacist Survey; Findings Show Strong Support for Distinguishable Names for Biologics and Need for Transparency in Labeling

October 14th, 2015

For Immediate Release:
October 13, 2015

WASHINGTON, DC – The Alliance for Safe Biologic Medicines (ASBM) today released the results of a survey of 401 U.S. pharmacists showing strong support for distinguishable names for biologics and biosimilars and the need for more transparency in labeling.

“This survey reinforces what ASBM has been hearing from pharmacists through our Continuing Education programs and makes it clear that they prefer distinguishable names and more complete specific approval labeling for biologics than is currently called for by the FDA,” said Executive Director Michael Reilly.

When asked if the FDA should require distinct non-proprietary names for all biologics, including biosimilars, 68% of pharmacists replied “Yes”, 23% said “no”, and 8% had no opinion.

“These results are not surprising;” said Ronald P Jordan, Dean at Chapman University School of Pharmacy, Orange County, CA and former President of the American Pharmacists Association (APhA). “Pharmacists know that their ability to improve patient outcomes and safety is hampered, unless they can clearly distinguish similar biologic medicines from one another. Distinguishable names are essential for tracking, reporting and discussion of specific product indications, contraindications or any potential adverse responses. To protect the hope these new agents offer in terms of better care and lower costs, clearly associating use and results accurately with each source, requires precise product identification.”

 

Regarding the labeling of biosimilars, the ASBM survey reveals that pharmacists want greater transparency than the FDA currently requires. When asked to rate from 1-5 the importance of certain information being included on a biosimilar’s label, high percentages rated the following as a “4” or a “5”, indicating high importance for inclusion:

  • 81%: Identifying the product as a biosimilar
  • 88%: Whether or not the biosimilar is interchangeable with (safely substitutable for) its reference product
  • 76% In which approved indications the biosimilar was studied, and for which approval was based on extrapolation from studies in other indications
  • 69% Distinguishing the source of data provided (originator product or biosimilar)

None of this information is currently present on the label of the only approved U.S. biosimilar, Zarxio (filgrastim-sndz).

“Pharmacists depend on the product label to advise patients and others on safe use, said Jordan. We hope these survey results positively inform the FDA as it drafts its upcoming labeling guidance.” Dean Jordan, who has served as a member of the ASBM Advisory Board since 2012, presented some of the data at the WHO’s 61st Consultation on International Nonproprietary Names (INN) today in Geneva.

The full pharmacist survey may be viewed here.

About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.

For more information, please contact:

Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
Email: [email protected]

 

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ASBM Presents at 61st WHO Naming Consultation

October 13th, 2015

Geneva, Switzerland – On October 13th, the Alliance for Safe Biologic Medicines (ASBM) presented before the World Health Organization’s (WHO’s) 61st Consultation on International Nonproprietary Names (INN). ASBM Chairman Harry L Gewanter, MD presented physician perspectives on biosimilar naming gathered from prescribers in eleven countries. This included data from ASBM’s recent survey of Latin American physicians, 94% of whom supported the WHO’s Biological Qualifier (BQ) Proposal, which would assign a unique four-letter suffix to each biologic. A similar and potentially-compatible naming system was proposed by the U.S. Food and Drug Administration (FDA) in Draft Guidance released September 28th.

“Clear product identification is critical to physicians around the world, and it aids regulators in tracking the long-term safety and efficacy of these medicines. We are encouraged by the positive reception the BQ is receiving both from physicians and from other leading regulators like the FDA, and are honored to participate in its development”, said Gewanter.

Joining him to present the pharmacist perspective on biologic naming was Ronald P. Jordan, Dean of the Chapman University School of Pharmacy, former president of the American Pharmacists Association and current ASBM Advisory Board member.

Jordan shared data from ASBM’s survey of 401 U.S. pharmacists, which found 68% supported distinguishable naming for all biologics, including biosimilars.

“These results are not surprising;” said Jordan. “Pharmacists know that their ability to improve patient outcomes and safety is hampered, unless they can clearly distinguish similar biologic medicines from one another. Distinguishable names are essential for tracking, reporting and discussion of specific product indications, contraindications or any potential adverse responses. To protect the hope these new agents offer in terms of better care and lower costs, clearly associating use and results accurately with each source, requires precise product identification.”

ASBM has been very supportive of the WHO’s draft BQ proposal, providing data and testimony in the last several INN Open Sessions for Stakeholders, most recently the 60th Consultation held in April, and the INN’s Front Page Meeting held in June.

ASBM Statement on FDA Draft Guidance: “Nonproprietary Naming of Biological Products”

September 1st, 2015

The Alliance for Safe Biologic Medicines commends the FDA for its leadership on biosimilars by releasing guidance that recognizes the need for all biologic medicines, including biosimilars, to be clearly distinguishable from one another. This clarity will aid in accurate product identification during prescribing, dispensing, and pharmacovigilance. Distinguishable naming is particularly important with the arrival of biosimilars, so that any unexpected effects or adverse events can be attributed to the correct product and that non-interchangeable biosimilars are not inadvertently and/or inappropriately substituted.

It has long been ASBM’s view that distinguishable naming will allow physicians to maintain an accurate patient record, help pharmacists promote patient safety, improve adverse event reporting, and promote manufacturer accountability. Further, the four-letter differentiating suffix proposed by the FDA is potentially compatible with the four-letter Biological Qualifier (BQ) suffix proposed by the World Health Organization (WHO), which if adopted would extend the protections of distinguishable naming to patients throughout the world, regardless of in which country they receive treatment.

While the FDA’s proposed four-letter suffix will prevent unnecessary and potentially harmful ambiguities, there still remains room for improvement. In particular, the differentiating suffix deliberately designed to be “devoid of meaning” creates an unnecessary barrier to the use of distinguishable suffixes. It is ASBM’s position that a uniform and meaningful, intuitive suffix applied consistently to all products by a single manufacturer would be more memorable and thus easier for healthcare providers to use, limit proliferation of suffixes, and reduce the likelihood of juxtaposition or confusion. The four-digit code used in FDA’s approval of the first biosimilar, Zarxio (filgrastim-sndz), for example, is clearly based on the name of the biosimilar’s sponsor, Sandoz.  Unlike the proposed random and meaningless suffix,  “-sndz” is not only memorable and logical, but it promotes manufacturer accountability.

ASBM welcomes the chance to submit further comments on the draft guidance and once again thanks the FDA for their leadership in releasing biosimilar guidance that reflects its longstanding commitment to patient safety and transparency.

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Latin American Physicians Support Distinguishable Biosimilar Naming, Survey Finds.

June 18th, 2015

Brazil, Mexico lead with 97% support for WHO’s BQ Proposal

 

Washington, DC- The Alliance for Safe Biologic Medicines (ASBM) today presented at the 51st Annual Meeting of the Drug Information Association (DIA). The presentation, titled “Physician Perspectives on Biosimilars” was given by John Lewis, Senior Vice President of the Association of Clinical Research Organizations, an ASBM Steering Committee member. Physician data regarding biosimilars was shared from five surveys and eleven countries, including for the first time the results of ASBM’s recent survey of Latin American physicians.

The Latin American survey, conducted May 2015, examined the perspectives of 399 physicians distributed equally across four countries: Argentina, Brazil, Colombia, and Mexico. Respondents were selected almost exclusively from six specialties in which biologic medicines are routinely prescribed: Dermatology, Endocrinology, Nephrology, Neurology, Oncology, and Rheumatology.

Most notably, the survey revealed that Latin American physicians overwhelmingly support the World Health Organization’s Biological Qualifier (BQ) proposal, which would allow biosimilars to be clearly distinguishable from the reference products upon which they are based for purposes of clear prescribing, dispensing, and long-term tracking of safety and efficacy. Under the BQ proposal this would be accomplished by the addition of a 4-digit code appended to the product’s International Nonproprietary Name (INN).

Wh­en asked “Do you think [the WHO’s proposed] “biologic qualifier” would be useful to you to help you ensure that your patients receive the right medicine that you have prescribed for them?”, a full 94% responded “Yes”.

Physicians in Brazil and Mexico had the strongest support, with 97% supporting the WHO’s proposal, while th­e lowest level of support found was among Colombian physicians, 89% of whom were in favor of the BQ.

These results are not surprising, explained Lewis: “Physicians need to clearly identify which medicine their patient is receiving in order to give them proper care. Last year ASBM surveyed physicians in Canada, where biosimilars are available, and found 79% supported distinguishable names.”

Physician prescribing practices also highlight the value of distinguishable names. A full 57% of respondents refer to a medicine exclusively by its nonproprietary name in a patient record, which could result in a patient receiving the wrong medicine.

Similarly, 28% of physicians surveyed indicated that they use the nonproprietary name exclusively when reporting adverse events, which could result in attribution to the wrong medicine.

The full results of the Latin American survey may be viewed here.

 

 

 

 

 

 

ASBM Presents at 60th WHO Naming Meeting

April 14th, 2015

Geneva, Switzerland – The Alliance for Safe Biologic Medicines (ASBM) Chairman Harry Gewanter, M.D. and International Advisory Board Chair and pharmacist, Philip J. Schneider, M.S., F.A.S.H.P., jointly presented at the World Health Organization’s (WHO) 60th International Nonproprietary Naming Stakeholders Session on Monday, April 13, 2015. The duo provided perspectives from both a physician and pharmacist viewpoint and offered support for the WHO’s Biological Qualifier (BQ) proposal.

This stakeholder session was the second time Dr. Gewanter was given the privilege to present and it was ASBM’s fourth time attending. ASBM was especially pleased that Dr. Schneider presented with Dr. Gewanter and was able to provide a pharmacist’s view on the topic of naming.

“We are so grateful for the opportunity to present at the WHO,” said Dr. Gewanter in his opening remarks. “Biosimilars’ high sensitivity to manufacturing differences, light, heat, denaturing; and their potential to stimulate unwanted immune reactions, means clear product identification is essential. ASBM believes that information, cooperation, communication and collaboration are vital to ensuring the best outcomes for patients across the globe. Implementing the WHO’s BQ proposal will make patient safety a priority.”
Dr. Schneider agreed that the BQ proposal would help ensure safety through clear product identification.

“All medicines, regardless of their similarity, should be easily identifiable,” said Dr. Schneider. “The pharmacy community has long advocated that drug names be clear to help avoid confusion and errors – and this could not be more true when it comes to highly complex biologic medicines. They must be easily distinguishable from each other and from other medicines. It is our hope that regulators around the world, including the FDA and EMA, adopt the BQ proposal by the WHO INN Programme, and its application within their jurisdictions.”

ASBM has been very supportive of the WHO’s draft BQ proposal that would assign a four-letter alphabetic code to all biologics. In September of last year, ASBM and 14 of its member groups submitted comments to the WHO supporting the BQ proposal because it ensures clear product identification and promotes manufacturer accountability.

About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.

For more information, please contact:

Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
Email: [email protected]

New ASBM Survey Provides Physicians’ Views on Biosimilar Labeling

March 23rd, 2015

Timely survey released as FDA approves first biosimilar

The Alliance for Safe Biologic Medicines today released the results from a survey on physicians’ priorities related to biosimilar labeling. ASBM first shared the key survey findings at the “The State of Autoimmune Disease: a National Summit” held at the National Press Club and hosted by the American Autoimmune Related Diseases Association. The survey reveals that physicians who prescribe biologics support transparent, clear labels with data that enables prescribers to learn about and evaluate the medicines available to their patients.

A strong consensus was apparent among the four hundred physicians surveyed, all of whom are board-certified, practice in the U.S. and prescribe biologic medicines. They include dermatologists, endocrinologists, oncologists, nephrologists, neurologists and rheumatologists. ASBM Executive Director Michael Reilly presented at the autoimmune summit and discussed the role biotech medicines play in treating autoimmune diseases. His presentation addressed the recent approval of the first biosimilar medicine in the U.S. and the timeliness of the new survey data as FDA considers the multiple biosimilar applications said to be pending before the agency.

“ASBM commends the FDA for their work to make biosimilars a reality for patients across the country,” said Reilly. “We believe this data provides FDA with clear guideposts for what is necessary to foster physician confidence in biosimilar medicines. The survey was conducted prior to the first biosimilar approval and is more consistent with the draft guidance released in 2012 than the label of the first biosimilar product.”

In the survey, participants were asked to rank the importance to the following questions on a five- point scale, with five being the highest:

  • How important is it that a product label for a biosimilar clearly indicates that it is a biosimilar? 90% of respondents rate the importance as a 4 or 5.
  • How important is it that the biosimilar label includes the analytical data developed by the biosimilar sponsor to demonstrate its analytical similarity to the reference product? 82% rate the importance as a 4 or a 5.
  • How important is it that the biosimilar label includes the clinical data, if any, submitted to FDA by the biosimilar sponsor to demonstrate that it is highly similar to the reference product? 83% rate the importance as a 4 or 5.
  • How important is it that the label explicitly states that specific indications or conditions of use that are approved for the originator product are NOT approved for the biosimilar product? 79% rate the importance as a 4 or 5.

ASBM has conducted surveys on physicians’ understanding of and views about biologics and biosimilars in the U.S., in Europe and in Canada, with the goal of providing to regulators the information needed to help advance the success and safe use of biologic medicines around the world.

View the survey here.

View the one pager here.

About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.

ASBM Educates Pharmacists on Biosimilars as FDA Makes First Approval

March 16th, 2015

CE Class Focuses on Fundamentals of Biosimilars

For Immediate Release:
March 16, 2015

EAST ELMHURST, NY – With the U.S. Food and Drug Administration’s (FDA) announcement of the first biosimilar approval, the Alliance for Safe Biologic Medicines (ASBM) held a five-hour class offered through the Long Island School of Pharmacy, to educate pharmacists on the fundamentals of these breakthrough new medicines. The continuing education (CE) class, “The Fundamentals of Biosimilars: What Every Pharmacist Will Need to Know,” was held at the New York LaGuardia Airport Marriott and explained what biologics and biosimilars are, how they are manufactured and regulatory challenges associated with them.

The class discussed the basic science and manufacturing of biologic medicines; the clinical implications of the key features of biologics size, complexity, sensitivity/propensity for change that distinguish biologic medicines from chemical drugs; their difference from generic drugs for purposes of patient care, pharmacovigilance, and pharmacy practice; and the important regulatory and policy considerations – that many state capitals are currently legislating across the country.

Speakers throughout the day stressed the need to ensure patient safety and the importance of physicians and pharmacists working together to ensure that safety. ASBM Chairman and pediatric rheumatologist, Dr. Harry Gewanter and Global Colon Cancer Association Executive Director Andrew Spiegel provided a physician and patient perspective and Bruce Babbitt, PhD, Principal Consultant, PAREXEL Consulting gave a regulatory overview for the students taking the CE class. Ronald P. Jordan, BPharm, RPh, FAPhA, Dean, Chapman University School of Pharmacy spoke on the importance of the evolving role of pharmacists as biosimilars are approved.

“We are pleased to have ASBM come to New York and give a thorough overview of such an important class of medicines. This is especially timely, given that the FDA just approved the very first biosimilar for U.S. patients two weeks ago,” said Joseph J. Bova, M.S., R.PhI, Director of Continuing Professional Education, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, who gave opening remarks. “Biosimilars are highly advanced prescription medicines and it’s now more important than ever that we are educating the pharmacist community.”

In his presentation, Philip J. Schneider, M.S., F.A.S.H.P., Professor and Associate Dean for Academic and Professional Affairs, University of Arizona College of Pharmacy and ASBM International Advisory Board Chair, focused on the critical importance of communication and the need for physicians and pharmacists to work together. In his presentation, “Biosimilars: A Collaborative Approach to Pharmacovigilance,” he said that working in collaboration with physicians and notifying them if a patient receives a different medicine than what was prescribed, will create a stronger track and trace system where the medication’s efficacy can be assessed and proper attribution will be ensured in the case of an adverse event. He also stressed the importance of continued education for pharmacists, physicians and patients for these lifesaving medicines.

ASBM hopes this is the first of many forums to work with the pharmacist community to ensure patient safety.

ASBM Commends FDA for Approval, Clear Naming of First Biosimilar

March 9th, 2015

 

ASBM Commends FDA for Approval, Clear Naming of First Biosimilar

For Immediate Release:
March 6, 2015

WASHINGTON – The Alliance for Safe Biologic Medicines today commended the U.S. Food and Drug Administration (FDA) on its approval of the first biosimilar to be available for sale in the U.S. market. Approval of Novartis’ Zarxio (filgrastim-sndz), biosimilar to Amgen’s Neupogen (filgrastim), was widely expected following the January recommendation by an FDA advisory panel that it be approved for all five indications for which the reference product is approved.

“The approval of the first biosimilar is a milestone for the agency and a significant positive development as patients and their physicians will have more treatment options,” said ASBM chairman Harry L Gewanter, MD. “We are particularly encouraged by the FDA’s recognition that a biosimilar is a different medication, distinct from its reference product, and that the distinguishable name given to this first biosimilar (filgrastim-sndz) allows healthcare providers to clearly differentiate it from the innovator medicine. The FDA is known around the world as a leader in patient safety, and distinguishable names are an affirmation of its commitment to transparency and accountability, and will make a difference in the safety of biologic medicines around the world. ASBM strongly encourages FDA to continue to use distinguishable naming for all future biosimilars it approves”, Gewanter added.

ASBM joined with more than 70 patient and physician groups in authoring a letter to FDA in August 2014 encouraging distinguishable naming of biosimilars. The FDA has stated, however, that the distinguishable naming of filgrastim-sndz should not interpreted as reflecting the agency’s support for a comprehensive policy of distinguishable naming for all biologics, including biosimilars. Such guidance on biosimilar naming is expected to be forthcoming shortly.

While “substantially similar” to the innovator product filgrastim, filgrastim-sndz has not yet received a designation of “interchangeable” by the FDA. Such a designation would indicate that switching between it and its reference product should produce the same effects in patients while posing no additional risks. Under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which lays out the biosimilar approval process, only biosimilars designated “interchangeable” may be substituted by a pharmacist without physician involvement.

One area of concern, however, is in the labeling of Zarxio. “The labeling of Zarxio does not state that it is not interchangeable with its reference product, what data were supplied to earn approval is not specified, nor whether or not the product was studied in all the indications for which it was approved. If we are to ensure that biosimilars are to be accepted and successful, patients and physicians need clarity in both labeling and naming.” Gewanter said.

About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.

For more information, please contact:

Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
Email: [email protected]

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ASBM European Survey Presented to Italian Ministry of Health

October 23rd, 2014

Launches discussion about the future of biosimilars in Italy

Results from a survey of 470 European physicians conducted by the Alliance for Safe Biologic Medicines (ASBM) set the stage for a stakeholder meeting at the Italian Ministry of Health to discuss the future of biosimilars policy in Italy. The October 20th event, titled “Biosimilars in Clinical Practice: Does Italy Need to Act” included regulators from the Italian Medicines Agency (AIFA), physicians from that country’s nephrology and dermatology societies, representatives from a hospital pharmacist organization, patient activists, and the Italian biotechnology trade association.

ASBM Executive Director Michael Reilly for the first time revealed the Italian responses from the ASBM survey that had previously been the subject of a whitepaper in the Journal of the Generics and Biosimilars Initiative, available here.

“The perspectives of those most familiar with the clinical use of biologic and biosimilar medicines – Italy’s physicians – offer invaluable guidance to its regulators as they craft biosimilar policy for Italy’s physicians, pharmacists and patients,” said Reilly.

The data demonstrated that physicians in Italy have a better understanding of biologics and biosimilars than physicians from the other four European countries surveyed (i.e., France, Germany, Spain and the U.K.) but also makes it clear that there remains a strong need for additional education and information on biosimilars among Italian physicians. For example, only 26% of Italian physicians considered themselves “very familiar” with biosimilars while 17% could not define or had not heard about biosimilars before.

A major topic of discussion was clarity in the naming of biologic medicines. Due to the extreme complexity of biologics, even the smallest difference between the structure of an innovator biologic and an attempted copy can have a significant impact on a patient, including adverse events such as unwanted immune responses. Yet when reporting adverse events, 22% of physicians record only the INN, which may lead to false attribution. Additionally, 25% of physicians use only the international non-proprietary name, or INN, when prescribing biologics, which may lead to patients receiving the wrong medicine from a pharmacist.

“The prescribing practices of Europe’s physicians demonstrate biosimilars must have the additional safeguard of distinguishable names to ensure clear prescribing and monitoring,” Reilly explained. “Distinguishable naming promotes accurate identification by physicians and pharmacists, helps regulators accurately track and understand these medicines, and promotes manufacturer accountability.”

View Mr. Reilly’s presentation here.

About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.

For more information, please contact:

Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
Email: [email protected]

ASBM Presents at WHO Meeting on Naming

October 17th, 2014


Introduces Chairman Gewanter, shows support for BQ proposal

Geneva – The Alliance for Safe Biologic Medicines (ASBM) presented at the World Health Organization’s (WHO) 59th International Nonproprietary Naming Stakeholders Session on Tuesday, October 14, 2014. This was the third time ASBM presented to the WHO but the first appearance for ASBM’s new chairman Dr. Harry L. Gewanter.

As a practicing pediatric rheumatologist and ASBM International Advisory Board (IAB) member, Harry L. Gewanter, MD, FAAP, FACR has been integrally involved in developing policy recommendations involving biosimilars that are patient-focused and physician friendly.

During his presentation “Global Biosimilar Naming Standards: Physician (and Patient) Perspectives” Dr. Gewanter thanked the WHO for the opportunity to present and for its efforts to prioritize patient safety.

At the request of the WHO, the proceedings of the stakeholder session are to remain confidential until the esteemed body has an opportunity to hold a closed session to discuss the “Biological Qualifier” proposal that was released in August.

ASBM has been very supportive of the WHO’s draft BQ proposal that would assign a four-letter alphabetic code to all biologics. In September, ASBM and 14 of its member groups submitted comments to the WHO supporting the BQ proposal because it ensures clear product identification and promotes manufacturer accountability.

In the U.S., ASBM has encouraged the FDA to follow the WHO’s lead. In August, ASBM and over 70 patient organizations wrote a letter encouraging the FDA to adopt a policy of distinguishable nonproprietary names for biosimilars and to issue guidance reflecting distinguishable naming in a timely manner as the first application for a biosimilar has been accepted.

About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.

For more information, please contact:

Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
Email: [email protected]