March 26, 2015
March 26, 2015
March 23, 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 The survey was conducted prior to the first biosimilar approval and is more consistent with the draft guidance released in 2012 than the label of the first biosimilar product.”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:
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.
March 16, 2015
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.
Biologic and Biosimilar Medicines: Their Purpose, Development, Structure, and Impact
Biologics and Biosimilars: The Patient Perspective
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
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
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
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.
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.
|
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.
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.
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.
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
###
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
###
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.
