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ASBM Statement on FDA Draft Guidance: “Nonproprietary Naming of Biological Products”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ASBM welcomes the chance to submit further comments on the draft guidance and once again thanks the FDA for their leadership in releasing biosimilar guidance that reflects its longstanding commitment to patient safety and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]

ASBM Names Harry L. Gewanter, MD as Incoming Chairman; Dean Philip Schneider as International Advisory Board Chair

August 7th, 2014

ARLINGTON, VA – Michael Reilly, executive director of the Alliance for Safe Biologic Medicines (ASBM) today announced pediatric rheumatologist and current ASBM International Advisory Board (IAB) member, Harry L. Gewanter, MD, FAAP, FACR as ASBM’s incoming chairman. In addition, Philip Schneider, MS, FASHP, Professor and Associate Dean at the University of Arizona, College of Pharmacy will serve as the International Advisory Board Chair. Dr. Schneider has served on the ASBM advisory board since September 2012.

“As a member of our International Advisory Board for three years, Dr. Gewanter has been instrumental in helping to craft ASBM’s policy recommendations and has taken an active role in its policy development and education efforts,” said Reilly. “We are excited for Dr. Gewanter to take a more prominent role within the organization and utilize his expertise to forward ASBM’s mission.”

Dr. Gewanter succeeds outgoing chairman Richard Dolinar, MD, who served as ASBM’s initial chairman since 2011. Dolinar has testified before the U.S. Food and Drug Administration (FDA) and the World Health Organization’s (WHO) International Nonproprietary Naming Consultation, as well as appeared as a global keynote speaker.

“Dr. Dolinar oversaw the creation, growth and maturation of ASBM — from an organization focused on shaping the biosimilar approval pathway in the United States to an internationally recognized voice that speaks for patient’s with serious chronic illnesses and the physicians who care for them,” said Dr. Gewanter. “During his tenure, Dr. Dolinar has assisted regulatory bodies as they craft international standards for biosimilars. I look forward to continuing his work as chairman and elevating the voice of patients and physicians in global regulatory decisions to provide patients and physicians additional safe and effective treatment options and greater transparency as biosimilars enter the marketplace.”

“Dr. Dolinar has been an outstanding leader in the education of physicians, patients and policymakers alike in the relatively new arena of biologics and biosimilars,” stated Reilly. “Under his leadership, our membership and impact has grown and we are grateful for his guidance of ASBM.”

Philip Schneider, will also serve ASBM in a new capacity as IAB Chair. During his tenure on ASBM’s Advisory Board, Dr. Schneider has helped educate policymakers on the importance of developing biosimilar policies that encourage collaboration between pharmacists and physicians.

“Pharmacists have an important role to play in the discussion of how biosimilars are treated and we are also the linchpin between patients and the medicines they take, ” stated Schneider. “I look forward to ensuring the pharmacy setting is equipped with the regulations needed to both ensure the safe administration of biosimilars, as well as provide access to potentially lower-cost alternatives to patients.”

Dr. Gewanter and Dr. Schneider will continue ASBM’s global advocacy for policies aimed at ensuring that patients worldwide receive the biologic they were prescribed, that biosimilars are held to high standards of safety and efficacy, and that these medicines can be reliably tracked for adverse events. Gewanter and Schneider will assume their positions on September 1.

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Massachusetts Governor Signs Pharmacy Legislation Creating a Pathway for Biosimilars

June 24th, 2014

Arlington, VA – Today, Governor Deval Patrick enacted biosimilars legislation updating Massachusetts’s pharmacy law and paving the way for the substitution of biosimilars deemed ‘interchangeable’ by the Food and Drug Administration (FDA).  The Governor took such action after swift passage of HB 3724 in both chambers of the General Court of the Commonwealth of Massachusetts.

As a physician, I applaud the Governor and the legislature for taking action to maintain the careful checks and balances needed in administering biologics,” stated Richard Dolinar, M.D., chairman of the Alliance for Safe Biologic Medicines (ASBM).  Unlike chemical drugs, biologics are complex medicines treating complicated conditions.  For that reason, regulations are needed to ensure doctors have a complete knowledge of what medicines are administered to their patients.  I feel confident that this new law strikes the right balance in maintaining the safety and efficacy of biologic products, while advancing more treatment options to patients.”

Biosimilars, or copies that are similar to but not exact versions of the original biologic, are expected to be approved by the FDA as early as 2015.  While the FDA will deem whether a biologic drug is approved and ‘interchangeable’, it is up to the states to decide whether one product may be substituted at the pharmacy level in place of the original biologic prescribed.

This new law allows pharmacists to substitute a biosimilar for a brand biologic once the biosimilar is deemed to be ‘interchangeable’.  The pharmacists would be required to communicate that a substitution has occurred both to the patient, as well as the prescribing physician.  Importantly, physicians would also maintain the right to prohibit substitutions from occurring if the prescriber instructs otherwise in writing.  The pharmacy will be required to maintain a record of each substitution for a period of at least a year.

Massachusetts is the third state this year to pass biosimilars legislation and pave the way for the substitution of biosimilars.  This creates a model for other states to follow in order to  address the necessary level of pharmacovigilance, while also promoting the use of these life-enhancing medicines.

“By ensuring that communication between physicians, pharmacists and patients remains a priority, we can monitor these complex therapies while providing the best quality and care,” concluded Dolinar.  We commend Governor Patrick for taking the necessary steps to protect this balance for patients in Massachusetts.”

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