ASBM Educates Pharmacists on Biosimilars as FDA Makes First Approval

March 16, 2015

babbitt-room

With the U.S. Food and Drug Administration’s (FDA) announcement of the first biosimilar approval, on March 15th, the Alliance for Safe Biologic Medicines (ASBM) held a five-hour class offered through the Long Island University (LIU 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 (LIU-Pharmacy), 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, “Biosimilar Substitution: 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.


View the March 15 Pharmacist Continuing Education Presentations Below: 

Biologic and Biosimilar Medicines: Their Purpose, Development, Structure, and Impact
Presented by 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

schneider101
In this presentation, Dr. Schneider outlines a brief history of biologic medicines, how they differ from traditional chemical medicines, identifies concerns about their sensitivity during manufacturing, handling and preparation. The concept of biosimilarity is explored and the issues of interchangeability and naming are introduced. View the presentation here.

 

Biologics and Biosimilars: The Patient Perspective
Presented by Andrew Spiegel, Esq.,
Executive Director, Global Colon Cancer Association; ASBM Steering Committee member

spiegel

In this presentation, patient advocate Andrew Spiegel examines the value of biologics and biosimilars in extending and improving the lives of patients around the world who suffer from serious conditions such as cancer. Mr. Spiegel explains the importance to patients of increased access to biosimilars, and of good communication and collaboration between their pharmacist and physician in regards to biosimilar substitutions, and use of distinguishable naming.  View this presentation here.

 

Clinical Perspectives on Biologic Medicines
Presented by Harry L. Gewanter, MD, FAAP, FACR,
Pediatric Rheumatologist; Chairman, Alliance for Safe Biologic Medicines

gewanter-ce

Drawing from three years of prescriber surveys conducted by ASBM in seven countries, Dr. Gewanter shares physician perspectives on biosimilar naming and substitution. Emerging issues in biosimilar naming are discussed, including FDA approval of the first U.S. biosimilar, and ASBM’s work with the World Health Organization to develop global naming standards.  Physician-pharmacist cooperation is emphasized as key to good pharmacovigilance. View this presentation here.

 

Biosimilars: Regulatory and Drug Development
Presented by Bruce Babbitt, PhD,
Principal Consultant, PAREXEL Consulting

babbitt-medium

Biologics regulatory expert Bruce Babbitt provides a detailed explanation of the development process for biologic medicines, with an emphasis on trial design and what type of data is required to demonstrate safety.  How biosimilarity is demonstrated in Europe and Canada is discussed, as is FDA’s current and upcoming guidance. FDA’s first biosimilar approval is discussed, and updates are given on several other biosimilars in the FDA approval pipeline. View this presentation here.

 

Biosimilar Substitution: A Collaborative Approach to Pharmacovigilance
Presented by 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

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Professor Schneider discusses how different U.S. states are approaching the question of determining under what circumstances a pharmacist can substitute an interchangeable biosimilar in place of a prescribed biologic, and what type of information must be recorded. An overview of recent legislation is provided and compared with approaches in Europe and Canada. The importance of pharmacist-physician collaboration in answering these policy questions is emphasized. View this presentation here.

 


Preparing for Biosimilars: The Evolving Role of Pharmacists in the Age of Biologic Therapies
Presented by Ronald P. Jordan, BPharm, RPh, FAPhA,
Dean, Chapman University School of Pharmacy

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Dean Ronald P. Jordan examines the changing roles and responsibilities of the pharmacist, and how biologic medicines offer increased opportunities for engagement and collaboration among patient, physician and pharmacist. The value of this cooperation is examined in terms of improving quality of care, reducing medication errors, and controlling costs. View Dean Jordan’s presentation here.

 

ASBM Educates Pharmacists on Biosimilars as FDA Makes First Approval

March 16, 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 Educates Pharmacists on Biosimilars as FDA Makes First Approval

March 16, 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.

Denver Business Journal: Biosimilars bill approved by Colorado Legislature

March 11, 2015

Colorado’s biosimilars bill letting pharmacists provide patients with generic drugs in place of name-brand biotech medicines now needs only a governor’s signature to become law.

The state House of Representatives passed the bill with only one ‘no’ vote on Tuesday, and it heads on to John Hickenlooper desk.

Read full story here.

ASBM Commends FDA for Approval, Clear Naming of First Biosimilar

March 9, 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: Michael@safebiologics.org

###

ASBM Commends FDA for Approval, Clear Naming of First Biosimilar

March 9, 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: Michael@safebiologics.org

###

The Jersey Journal: Making sure new medicines are safe

March 9, 2015

Most of the pills and injectable medications you take today are made from inert materials in a lab somewhere, but the stuff you may take next year could be made from body cells or plants.  They work really well. Perhaps they’ll even cure your problem, but currently they are very expensive.

You’ve heard about them –  new kinds of medicine used to treat cancer, arthritis, multiple sclerosis, AIDS and other debilitating diseases – but you may not know that something very like them will be widely available soon and more affordable.  They’re called biologics and the oldest of them are coming off patent very soon.  So pharmaceutical companies all over the world have developed less expensive versions and want to hit the U.S. market as quickly as possible.

Government at both the federal and state level is grappling with the issue of how to substitute the expensive drugs with the newer versions while ensuring the substitutes work without causing harm.  The first issue was what to call them.  Cheaper versions of original drugs with inert ingredients are called generics, which means they are virtually identical to the original and work in exactly the same way.

But since no two living organisms are precisely alike, cells grown in one lab won’t be identical to cells grown in another.  So they can’t be accurately described as generic.  New versions are called bio-similars, or briefly bio-sims.  They’ll be considerably less expensive than the original meds because their manufacturers didn’t have to cover the costs of research.

Predictions are that patients could save as much as 30 percent of current costs. That’s a huge savings to insurers, including the State Health Plan, Medicaid, and Medicare. But since the bio-sims won’t be exactly like the original drugs, the results they produce may not be exactly alike either.  Even the most subtle differences in molecules can be important.

Assemblywoman Pamela Lampitt, D-Camden, believes both doctors and patients should be aware of exactly what they’re taking, so she’s introduced bill A2477 to spell out rules for dispensing and reporting. As with today’s generics, a physician could write “Do not substitute” on the prescription and the pharmacist must follow that instruction.

Otherwise, a pharmacist, using a list prepared by FDA, may substitute a bio-sim for the original medication but would have to print on the label the name of the dispensed product noting it is an interchangeable bio-sim, and within five days notify the prescribing physician the substitution was made. Pharmacy representatives don’t like the notification requirements.  Some say they would be too costly and time-consuming, while others believe they might lead patients to feel they’re getting an inferior product.

The bill’s co-sponsor, Assemblyman Herb Conaway, D- Burlington, who is a medical doctor and chair of the Assembly Health Committee, has held one hearing on the bill but no action was taken.  Sen. Joseph Vitale, D-Union, the Senate sponsor, is waiting for the Assembly to act before he jumps into the fray. Eight states have enacted similar laws recently.

The Washington-based Alliance for Safe Biologic Medicines strongly supports the bill’s requirement to notify physicians because they believe tracking and monitoring the use of bio-sims is essential to lessen risks and foster continuing improvements.  Lampitt says the FDA is likely to have bio-sims approved before the end of the year, so her goal is to have this legislation passed by June, allowing time for physicians and pharmacists to get ready.  Patients are ready now.

EDITOR’S NOTE: A former state assemblywoman from Jersey City, Joan Quigley is the president and CEO of the North Hudson Community Action Corp. in Union City. Her column appears in The Jersey Journal every Tuesday.

The Jersey Journal: Making sure new medicines are safe

March 9, 2015

Most of the pills and injectable medications you take today are made from inert materials in a lab somewhere, but the stuff you may take next year could be made from body cells or plants.  They work really well. Perhaps they’ll even cure your problem, but currently they are very expensive.

You’ve heard about them –  new kinds of medicine used to treat cancer, arthritis, multiple sclerosis, AIDS and other debilitating diseases – but you may not know that something very like them will be widely available soon and more affordable.  They’re called biologics and the oldest of them are coming off patent very soon.  So pharmaceutical companies all over the world have developed less expensive versions and want to hit the U.S. market as quickly as possible.

Government at both the federal and state level is grappling with the issue of how to substitute the expensive drugs with the newer versions while ensuring the substitutes work without causing harm.  The first issue was what to call them.  Cheaper versions of original drugs with inert ingredients are called generics, which means they are virtually identical to the original and work in exactly the same way.

But since no two living organisms are precisely alike, cells grown in one lab won’t be identical to cells grown in another.  So they can’t be accurately described as generic.  New versions are called bio-similars, or briefly bio-sims.  They’ll be considerably less expensive than the original meds because their manufacturers didn’t have to cover the costs of research.

Predictions are that patients could save as much as 30 percent of current costs. That’s a huge savings to insurers, including the State Health Plan, Medicaid, and Medicare. But since the bio-sims won’t be exactly like the original drugs, the results they produce may not be exactly alike either.  Even the most subtle differences in molecules can be important.

Assemblywoman Pamela Lampitt, D-Camden, believes both doctors and patients should be aware of exactly what they’re taking, so she’s introduced bill A2477 to spell out rules for dispensing and reporting. As with today’s generics, a physician could write “Do not substitute” on the prescription and the pharmacist must follow that instruction.

Otherwise, a pharmacist, using a list prepared by FDA, may substitute a bio-sim for the original medication but would have to print on the label the name of the dispensed product noting it is an interchangeable bio-sim, and within five days notify the prescribing physician the substitution was made. Pharmacy representatives don’t like the notification requirements.  Some say they would be too costly and time-consuming, while others believe they might lead patients to feel they’re getting an inferior product.

The bill’s co-sponsor, Assemblyman Herb Conaway, D- Burlington, who is a medical doctor and chair of the Assembly Health Committee, has held one hearing on the bill but no action was taken.  Sen. Joseph Vitale, D-Union, the Senate sponsor, is waiting for the Assembly to act before he jumps into the fray. Eight states have enacted similar laws recently.

The Washington-based Alliance for Safe Biologic Medicines strongly supports the bill’s requirement to notify physicians because they believe tracking and monitoring the use of bio-sims is essential to lessen risks and foster continuing improvements.  Lampitt says the FDA is likely to have bio-sims approved before the end of the year, so her goal is to have this legislation passed by June, allowing time for physicians and pharmacists to get ready.  Patients are ready now.

EDITOR’S NOTE: A former state assemblywoman from Jersey City, Joan Quigley is the president and CEO of the North Hudson Community Action Corp. in Union City. Her column appears in The Jersey Journal every Tuesday.

FDA approves first biosimilar product Zarxio

March 6, 2015

The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States.
Biological products are generally derived from a living organism. They can come from many sources, including humans, animals, microorganisms or yeast.

A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.

Sandoz, Inc.’s Zarxio is biosimilar to Amgen Inc.’s Neupogen (filgrastim), which was originally licensed in 1991. Zarxio is approved for the same indications as Neupogen, and can be prescribed by a health care professional for:

  • patients with cancer receiving myelosuppressive chemotherapy;
  • patients with acute myeloid leukemia receiving induction or consolidation chemotherapy;
  • patients with cancer undergoing bone marrow transplantation;
  • patients undergoing autologous peripheral blood progenitor cell collection and therapy; and
  • patients with severe chronic neutropenia.

“Biosimilars will provide access to important therapies for patients who need them,” said FDA Commissioner Margaret A. Hamburg, M.D. “Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.”
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was passed as part of the Affordable Care Act that President Obama signed into law in March 2010. The BPCI Act created an abbreviated licensure pathway for biological products shown to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product, called the “reference product.” This abbreviated licensure pathway under section 351(k) of the Public Health Service Act permits reliance on certain existing scientific knowledge about the safety and effectiveness of the reference product, and enables a biosimilar biological product to be licensed based on less than a full complement of product-specific preclinical and clinical data.

A biosimilar product can only be approved by the FDA if it has the same mechanism(s) of action, route(s) of administration, dosage form(s) and strength(s) as the reference product, and only for the indication(s) and condition(s) of use that have been approved for the reference product. The facilities where biosimilars are manufactured must also meet the FDA’s standards.

The FDA’s approval of Zarxio is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Zarxio is biosimilar to Neupogen. Zarxio has been approved as biosimilar, not as an interchangeable product. Under the BPCI Act, a biological product that that has been approved as an “interchangeable” may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.

The most common expected side effects of Zarxio are aching in the bones or muscles and redness, swelling or itching at injection site. Serious side effects may include spleen rupture; serious allergic reactions that may cause rash, shortness of breath, wheezing and/or swelling around the mouth and eyes; fast pulse and sweating; and acute respiratory distress syndrome, a lung disease that can cause shortness of breath, difficulty breathing or increase the rate of breathing.

For this approval, the FDA has designated a placeholder nonproprietary name for this product as “filgrastim-sndz.” The provision of a placeholder nonproprietary name for this product should not be viewed as reflective of the agency’s decision on a comprehensive naming policy for biosimilar and other biological products. While the FDA has not yet issued draft guidance on how current and future biological products marketed in the United States should be named, the agency intends to do so in the near future.

Sandoz, a Novartis company, is based in Princeton, New Jersey. Neupogen is marketed by Amgen, based in San Diego, California.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA approves first biosimilar product Zarxio

March 6, 2015

The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States.
Biological products are generally derived from a living organism. They can come from many sources, including humans, animals, microorganisms or yeast.

A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.

Sandoz, Inc.’s Zarxio is biosimilar to Amgen Inc.’s Neupogen (filgrastim), which was originally licensed in 1991. Zarxio is approved for the same indications as Neupogen, and can be prescribed by a health care professional for:

  • patients with cancer receiving myelosuppressive chemotherapy;
  • patients with acute myeloid leukemia receiving induction or consolidation chemotherapy;
  • patients with cancer undergoing bone marrow transplantation;
  • patients undergoing autologous peripheral blood progenitor cell collection and therapy; and
  • patients with severe chronic neutropenia.

“Biosimilars will provide access to important therapies for patients who need them,” said FDA Commissioner Margaret A. Hamburg, M.D. “Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.”
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was passed as part of the Affordable Care Act that President Obama signed into law in March 2010. The BPCI Act created an abbreviated licensure pathway for biological products shown to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product, called the “reference product.” This abbreviated licensure pathway under section 351(k) of the Public Health Service Act permits reliance on certain existing scientific knowledge about the safety and effectiveness of the reference product, and enables a biosimilar biological product to be licensed based on less than a full complement of product-specific preclinical and clinical data.

A biosimilar product can only be approved by the FDA if it has the same mechanism(s) of action, route(s) of administration, dosage form(s) and strength(s) as the reference product, and only for the indication(s) and condition(s) of use that have been approved for the reference product. The facilities where biosimilars are manufactured must also meet the FDA’s standards.

The FDA’s approval of Zarxio is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Zarxio is biosimilar to Neupogen. Zarxio has been approved as biosimilar, not as an interchangeable product. Under the BPCI Act, a biological product that that has been approved as an “interchangeable” may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.

The most common expected side effects of Zarxio are aching in the bones or muscles and redness, swelling or itching at injection site. Serious side effects may include spleen rupture; serious allergic reactions that may cause rash, shortness of breath, wheezing and/or swelling around the mouth and eyes; fast pulse and sweating; and acute respiratory distress syndrome, a lung disease that can cause shortness of breath, difficulty breathing or increase the rate of breathing.

For this approval, the FDA has designated a placeholder nonproprietary name for this product as “filgrastim-sndz.” The provision of a placeholder nonproprietary name for this product should not be viewed as reflective of the agency’s decision on a comprehensive naming policy for biosimilar and other biological products. While the FDA has not yet issued draft guidance on how current and future biological products marketed in the United States should be named, the agency intends to do so in the near future.

Sandoz, a Novartis company, is based in Princeton, New Jersey. Neupogen is marketed by Amgen, based in San Diego, California.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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