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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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Indiana Governor Signs Biosimilars Legislation Ensuring Patient Safety

March 25th, 2014

Arlington, VA – Today, the Alliance for Safe Biologic Medicines (ASBM) applauds Governor Mike Pence of Indiana in signing legislation to ensure the safe substitution of interchangeable biologic medicines, approved by the Food and Drug Administration (FDA).

“We commend Indiana in taking the lead to make patient safety the priority as life-altering biologics become more readily available to patients in the United States,” commented Richard Dolinar, M.D. Chairman of ASBM.

Senate Bill 262 amends Indiana pharmacy regulations for the treatment of biosimilars by maintaining the proper communication between pharmacists and prescribing physicians. Specifically, the new law provides that pharmacist must notify the treating physician within 10 days of the exact biologic product by manufacturer in order to attribute any adverse events that may occur. In addition, the pharmacist is required to retain a written record of the biosimilar substitution for a period of no less than two years. The pharmacists must also make sure the patient is aware of substitutions that occur.

“As a practicing endocrinologist, when it comes to treating patients, I need to know what medicines my patients are taking to properly manage disease,” continued Dolinar. “Without proper communication, I may not be able to address setbacks in treatment or accurately attribute adverse events and may lose valuable treatment time. This law ensures there are procedures in place to facilitate that exchange of information when biologic medicines are dispensed, while also expanding patient access to biologic medicines.”

Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Unlike drugs derived from chemicals, biologics are manufactured using a unique process with living cells and for this reason no two biologics made from different cell lines are ever identical. When attempting to replicate biologics, their “copies,” known as biosimilars, are similar to, but not exact versions of the biologic they aim to replicate and are often mistakenly referred to as “generics.” Even the smallest difference in the structure of a biologic medicine and its attempted copy can have a significant impact on a patient.

ASBM has supported the FDA in its mission to safely bring biosimilars to the U.S. and will continue to work with state legislatures in advocating for the necessary substitution guidelines needed to ensure patient safety remains the priority.

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ASBM Presents New European Survey Findings on Biosimilars and the Importance of Nonproprietary Naming

November 22nd, 2013

Dublin, Ireland – The Alliance for Safe Biologic Medicines (ASBM) today released the results of a new survey on European physicians’ views on biosimilar naming. ASBM Executive Director Michael Reilly presented the findings at the Drug Information Association (DIA) Biosimilars Workshop in Dublin, Ireland. The key findings showed that nonproprietary names matter to patient safety.

The survey examined responses from more than 470 prescribers located in the United Kingdom, France, Germany, Italy and Spain. The respondents included nephrologists, rheumatologists, dermatologists, neurologists, endocrinologists, and oncologists – all specialties that prescribe biologics.

Key findings from the survey include:

  • 53% of physicians surveyed felt that an identical nonproprietary name implies identical structure – which will not be the case for biosimilar medicines
  • 61% of surveyed physicians said that identical nonproprietary names imply that the medicines are approved for the same indications – which is not necessarily the case
  • 24% of reporting physicians record only the non-proprietary name of the biological product in the patient record

In September 2012, ASBM conducted a similar survey that examined practices and perspectives on biosimilar naming and substitution of over 350 physicians in the U.S. The survey was intended to provide data to help support the U.S. Food and Drug Administration (FDA) as they determine biosimilar policies that will have a fundamental impact on patient safety.

Unlike physicians in the U.S., where biosimilars are not yet available, the perspective of European physicians reflects hands-on clinical experience with biosimilars in a therapeutic setting.

The responses of the European physicians demonstrate the need for distinguishable nonproprietary names to be given for all biologics. Biosimilars, in contrast to generic drugs, may have different structure and therapeutic profile, and be approved for different indications than the reference product.

In his presentation, Reilly noted the commonality of physicians’ views across the ocean despite the significant difference in their respective experience with biosimilars since biosimilars have been on the market in Europe for several years but are not yet approved in the U.S.

“The consistency of physician perspective in the U.S. and Europe with regard to nonproprietary naming of biologics is striking.  Identical nonproprietary names are generally understood to mean that the products are both identical and approved for the same indications – incorrect and potentially unsafe assumptions for biologics.

“More and more biologic medicines, both innovative and biosimilar, are being approved around the world.  How these products are named will clearly play an important role in facilitating global pharmacovigilance and the safe use of these medicines.”

Both surveys were conducted by Industry Standard Research. European Survey data will be shared in the participating countries following the upcoming holiday season.

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

E: Michael@safebiologics.org

ASBM Presents at WHO Meeting on Naming in Geneva

October 22nd, 2013

ASBM Presents at WHO Meeting on Naming in Geneva
Calls for Distinct Non-Proprietary Names to Ensure Patient Safety

Geneva, Switzerland - The Alliance for Safe Biologic Medicines (ASBM) today presented at the World Health Organization’s (WHO) 57th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. During his presentation, ASBM Chairman, Richard Dolinar, M.D., called for the use of distinct non-propriety names for biologic medicines so that it is clear which medicine or medicines a patient received.  Said Dolinar, “It is essential to patient safety that adverse events can be accurately traced back to the correct product.  Distinguishable non-proprietary names for biologic medicines make that more likely.”

For nearly three years, ASBM has been dedicated to ensuring that patient safety is at the forefront of biosimilar policy across the globe as regulatory bodies around the world approve biosimilars for use. ASBM has strongly advocated that all biologics be given distinct non-proprietary names to facilitate accurate attribution of adverse events. The non-proprietary name of a reference product and product/s biosimilar to it, should have a common, shared root but have distinct and differentiating suffixes.  This will enable regulators to hold manufacturers accountable for the quality of their medicines.

Because biologics are made using living cells, as opposed to traditional chemical drugs, they are highly sensitive to the manufacturing process, storage, handling, etc. and small changes in the medicine can have important implications for patients.  ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety.

In his presentation, Dr. Dolinar, a practicing endocrinologist, thanked the WHO for seeking input from the physician and patient communities and urged regulators worldwide to give biosimilars distinguishable names.

“We are grateful for the continued opportunities the WHO has given stakeholders like us to provide input as biosimilar policies are developed,” said Dr. Dolinar. “Product names are a foundational element of communication among health care providers and will have implications for the safe use of biologic medicines.  When we speak about drugs, we need to be very specific. If a patient has an adverse reaction, which can occur months after receiving a biologic medicine, we need to be able to properly identify that medication. Instituting a system of distinguishable names will achieve the common goal of enhancing access to these life-changing therapies, while also protecting the safety of the patients.”

In advance of the WHO meeting, ASBM wrote two letters to WHO regarding the need for instituting a system of distinguishable names.

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, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. Visit us at www.SafeBiologics.org.

For more information, please contact:

Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
E: Michael@safebiologics.org

IAPO Mexico City Meeting Includes Discussion on Biosimilars

September 23rd, 2013

On September 23rd, in Mexico City, the International Alliance of Patients’ Organizations (IAPO) hosted a discussion on biosimilars at their Latin American Multi-Stakeholder Seminar.  The meeting was attended by patient and interest groups from the region as well as ASBM Executive Director, Michael Reilly, and Global Colon Cancer Association (GCCA) Co-Executive Director, Andy Spiegel.

The discussion focused on how patient groups can influence biosimilar health policy in Latin American countries, especially Mexico and Columbia, and the need for stringent global regulatory standards that ensure patient safety when it comes to these complex medicines.

ASBM Steering Committee member, GCCA, has officially joined the International Alliance of Patients’ Organizations (IAPO) this year. The Mexico City event served as an opportunity to build on IAPO’s interest in the biosimilars issue following the successful Workshop on Biosimilars Medicines held in Geneva earlier in the year. IAPO is a global alliance of over 200 patients’ organizations representing 50 disease areas and over 60 countries worldwide.

The Alliance for Safe Biologic Medicines Statement on the Need for Unique Names for All Biologic Medicines

September 20th, 2013

WASHINGTON, DC – Alliance for Safe Biologic Medicines (ASBM) chairman, Richard Dolinar M.D., added a physician’s perspective to the ongoing discussion around the naming of biologic medicines, including biosimilars.

“Biologics are highly sensitive to the manufacturing process and their environment; slight differences can have unexpected results,” stated Dolinar. “As a physician, patient safety is paramount. I need to know as quickly as possible when and which product is associated with an unexpected outcome in order to treat my patients effectively. Importantly, identical names imply identical products, which will not be the case when biologics are made using different manufacturing processes and/or cell lines. If distinct non-proprietary names are not given to products, we may waste valuable treatment time trying to identify which medicine was actually the root cause, and the patient will suffer.”

Dolinar stressed that unique distinguishable non-proprietary names play a central role in pharmacovigilance and traceability systems that enable clearer communication with patients, medical staff and pharmacists. A white paper authored by ASBM entitled, “It’s All About the Name: What is the Imperative of Adopting Unique Names For Biologic and Biosimilar Therapeutics?” explains how biologic medicines are different from traditional chemical drugs and present unique safety concerns.

“Our research in the United States clearly indicates that physicians familiar with biologics know minor changes can make a big difference for sick patients,” said Dolinar.  “Instituting a system of unique names for biologic medicines will achieve the common goal of enhancing access to life-changing therapies, while also protecting the safety of the patients,” Dolinar concluded.

ASBM called for the use of distinguishable names in a March 20th letter directly to Dr. Balocco Mattavelli, INN Program Manager at the WHO.  Dr. Dolinar has also presented at the “Regulator Forum on Biologic Naming and Traceability” hosted by Health Canada and BIOTECanada on June 26, 2013 that Dr. Balocco attended. ASBM’s most recent statement was sent to Dr. Margaret Chang, WHO Director-General, on July 31, 2013 in advance of their upcoming 57th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances. ASBM will also be present at that meeting to be held in Geneva on October 22, 2013.

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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, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.

For more information, please contact:

http://safebiologics.org/naming.php

Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
E: Michael@safebiologics.org

Dolinar Adds to the Emerging Consensus Among Stakeholders on the Need for Unique Names at an International Regulator Forum

July 1st, 2013

Ottawa, ONTARIO – Alliance for Safe Biologic Medicines (ASBM) chairman, Richard Dolinar M.D., was one of a small group of patient advocates invited to address international regulators at the “Regulator Forum on Biologic Naming and Traceability” hosted by Health Canada and BIOTECanada on June 26 and 27. Dolinar’s presentation added a physician’s perspective to the emerging consensus that unique product names are key to patient safety.

“Biologics are highly sensitive to the manufacturing process and their environment; slight differences can have unexpected results,” stated Dr. Dolinar at the event. “As a physician, patient safety is paramount. I need to know as quickly as possible when and which product is associated with an unexpected outcome in order to treat my patients effectively. Identical names imply identical products, which will not be the case when biologics are made using different manufacturing processes and/or cell lines. If distinct non-proprietary names are not given to products, we may waste valuable treatment time trying to identify the root cause, and the patient will suffer.”

Dolinar’s presentation stressed that unique distinguishable INN names play a central role in pharmacovigilance and traceability systems that enable clearer communication with patients, medical staff and pharmacists. His presentation reviewed findings in a white paper authored by ASBM entitled, “It’s All About the Name: What is the Imperative of Adopting Unique Names For Biologic and Biosimilar Therapeutics?” The paper explains how biologic medicines are different from traditional chemical drugs and present unique safety concerns. Dolinar’s presentation in Ottawa followed a presentation earlier in the week at the DIA conference in Boston and furthered the dialogue with the international community towards a consensus among stakeholders on the need for unique names for biosimilars.

“Our research in the United States clearly indicates that physicians familiar with biologics know minor changes can make a big difference for sick patients,” said Dolinar. “Cases have occurred wherein a prescribing physician has mistakenly omitted the distinguishing prefix, resulting in a patient receiving the wrong medication, at the wrong dose. Instituting a system of unique names for biologic medicines will achieve the common goal of enhancing access to life-changing therapies, while also protecting the safety of the patients,” Dolinar concluded.

The findings shared were also expressed in a March 20th letter directly to Dr. Balocco Mattavelli, INN Program Manager at the WHO in Geneva. Dr. Balocco joined Dr. Dolinar and ASBM Executive Director Michael Reilly, along with a hospital pharmacist, and the Chair of the International Alliance for Patient Organizations (IAPO) at the Ottawa forum.

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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, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. Visit us at www.SafeBiologics.org.

For more information, please contact:
Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
E: Michael@safebiologics.org

EuropaBio joins the Alliance for Safe Biologic Medicines

June 27th, 2013

WASHINGTON, DC- The Alliance for Safe Biologic Medicines (ASBM) is pleased to announce the addition of EuropaBio to its membership.

EuropaBio is the European Association for Bioindustries, bringing together bioscience companies from all fields of research and development, testing, manufacturing and distribution of biotechnology products. It has 56 corporate members, 14 associate members and Bio Regions and 19 National Biotechnology Associations- representing some 1800 small and medium sized enterprises across Europe. Its members are involved in research, development, testing, manufacturing and commercialisation of biotechnology products and processes, and have a wide range of activities: human and animal health care, diagnostics, bio-informatics, chemicals, crop protection, agriculture, food and environmental products and services.

“With the partnership of EuropaBio, the Alliance for Safe Biologic Medicines can continue to ensure the affordability and accessibility of biologic medications while never compromising on patient safety, here in the US and across the globe.” stated Dr. Richard Dolinar, Chairman of the Alliance for Safe Biologic Medicines. “We are pleased to have such an authoritative international partner who brings an experience with biosimilars that does not currently exist in the U.S. We will lean heavily on EuropaBio and its members to better understand the approach taken in the E.U. that has led to the successful introduction of biosimilars.”

In April 2013, the Process on Corporate Responsibility in the field of Pharmaceuticals, spearheaded by Commission Vice-President Antonio Tajani, published its long-awaited report on biosimilars. As members of the initiative, EuropaBio worked alongside the Commission and other stakeholders on the consensus document, which discusses the specifics around biosimilar medicinal products, the requirements for their marketing authorization in the EU, their market performance, and the necessary conditions within the EU pharmaceutical market to ensure informed and adequate use of these medicines.

The Alliance for Safe Biologic Medicines has had an established International Advisory Board for the purpose of providing ASBM’s Chairman, member organizations, and the general public guidance and expertise as the FDA moves forward to implement a pathway for biosimilar medications. However, the partnership with EuropaBio furthers that mission by serving as an important resource as they evaluate the future of biologics and biosimilars in the United States, Canada, and the EU.

“Countries across the globe have gathered much data which can, at a minimum, help inform our own policy makers,” Executive Director of ASBM, Michael Reilly, stated. “The ASBM will take advantage of the opportunity to learn from their experiences, both positive and negative.”

Miriam Gargesi, Director of Healthcare at EuropaBio added: “We look forward to working with ASBM to continue educating the public on the opportunities and challenges associated with biotechnology, including biologic and biosimilar medicines. The development and manufacturing process for all biologic medicines, including biosimilars, is more complex compared to the processes associated with generics and other chemical, small molecule products. It is therefore necessary that a robust regulatory system and adequate label transparency are in place for all biological medicines, to ensure that physicians have access to and a good understanding of the most appropriate treatments for their patients.”

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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, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. Visit us at www.SafeBiologics.org.

For more information, please contact:

Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
E: Michael@safebiologics.org

Rosalind Travers
Communications Manager, EuropaBio
Phone: +32 2 739 1173
GSM: +32 (0) 478 680 301
E: r.travers@europabio.org

Quality, Manufacturing Transparency Key to Avoiding Biologic Drug Shortages: Dolinar Addresses 49th Annual DIA Conference

June 25th, 2013

BOSTON, Mass. – Speaking at the 49th Annual Drug Information Association (DIA) Conference, Dr. Richard Dolinar, chairman of The Alliance for Safe Biologic Medicines (ASBM), presented an analysis of past drug shortages and discussed how policies toward biologic drugs can be developed to guard against short supply. Dr. Dolinar’s presentation, entitled “Characterizing Drug Shortages and Their Causes: Anticipated Future Trends,” stresses that quality and consistency are vital for ensuring a steady and safe supply of biologic medicines for patients.

“It is important for prescribers to understand how policies toward biologic drugs are taking shape and why manufacturing quality remains key to supply,” said Dr. Dolinar, a practicing endocrinologist. “Biologics are incredibly complex and as such not yet well understood, but we can avoid the pitfalls of the past by developing sound policy that centers on patient safety and efficacy.”

“Prescribers have an important role to play in terms of offering a clinical, evidence-based perspective on the safe use of biologics,” said Dr. Dolinar. “As a prescriber, I will pay attention to a manufacturer’s track record on quality and constancy of supply to ensure the best outcomes for my patients.”

In his presentation, Dr. Dolinar discussed the findings of a 2011 Food and Drug Administration (FDA) analysis that attributed a majority of drug shortages to manufacturing problems and quality concerns. Of those shortages, 89 percent occurred among sterile injectables, which share a delivery mechanism with biologics.

He also referenced a 2013 study by University of Pennsylvania researchers, which found that 83 percent of oncologists had experienced drug shortages in the past six months. Of those physicians, 79 percent had to switch patients to different medicines, and 43 percent had to delay treatments.

“Shortages that force physicians to postpone treatment or switch patients to less effective medication are a serious risk to patient health,” said Dr. Dolinar.

Dr. Dolinar also stressed that giving biosimilars distinct non-proprietary names different from their reference biologic is essential for holding manufacturers responsible for their products, accurately attributing adverse events, and maintaining a safe biotech drug supply.

“Manufacturing transparency is vital. We cannot confuse problems with one biosimilar product with complications from another,” Dr. Dolinar concluded. “We must be able to distinctly identify products in order to partner effectively with patients, manufacturers, and FDA to keep the biotech drug supply safe and effectively treat disease.”

The DIA 2013 49th Annual Meeting is the largest global multidisciplinary event for professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related products. The DIA Annual Meeting covers all aspects of the life sciences industries offering more than 250 sessions on hot topics and is key for individuals in the industry.

See Dolinar’s presentation.

See DIA conference highlights here.

 

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ASBM Chairman: Patient Safety Key to Creating Global Biosimilar Standards

March 7th, 2013

WASHINGTON – Dr. Richard Dolinar, chairman of the Alliance for Safe Biologic Medicines (ASBM) presented on March 5, 2013 at the Center for Business Intelligence 8th Annual Biosimilars Summit in Washington, D.C. Dr. Dolinar’s presentation, “Assessing Global Standards for Biologic Medicines” stressed the need for a global regulatory environment for biosimilars that places patient safety above all else and delivers high quality standards regardless of where the biosimilar is manufactured.

“Creating global standards for biosimilars has to boil down to one thing – patient safety – no matter where in the world the biosimilars are approved,” said Dr. Dolinar. “To safely bring biosimilars to patients, we should build on the science-based approach taken by the European Union (EU) and establish quality standards regarding the approval process, approach to naming, and substitution policies.”

“There is much to be learned from the great progress that has already begun in the EU, Canada and other countries. ASBM is committed to supporting the efforts of the U.S. Food and Drug Administration in their mission to safely bring biosimilars to the U.S., and helping develop and endorse standards that will bring effective biologic and biosimilar treatments to patients across the world.”

View Dr. Dolinar’s full presentation here.

Biologics are used to treat cancer, diabetes, MS, rheumatoid arthritis and other debilitating diseases. On February 9, 2012, the FDA announced the publication of draft guidance documents relating to the developments of biosimilars, which are similar to, but not exact copies of biologics. The guidance documents were a significant step in establishing a biosimilars pathway and as the FDA moves forward, ASBM will continue to work to ensure patient safety remains the priority.

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. Visit us at www.SafeBiologics.org.