Andrew Spiegel Testimony in Support of HB 746

October 10, 2013

Re: Support of HB 746-Biosimilars

Thank you for providing this opportunity to speak about this important issue.

My name is Andrew Spiegel.  I am the Executive Director of the Global Colon Cancer Alliance. The Global Colon Cancer Alliance (GCCA) is the voice for colon cancer patients worldwide. Before running the GCCA, I was CEO and a founding member of the US based Colon Cancer Alliance, the oldest and largest national colorectal cancer patient advocacy organization.  The GCCA’s mission is to effectively address issues and provide information surrounding colorectal cancer to clinicians, patients and caregivers across the globe.  The Global Colon Cancer Alliance is uniting people from all corners of the world in the fight against colon cancer and is effectively increasing awareness, earlier diagnosis and access to treatment of a disease that kills more than 600,000 people worldwide annually.

I personally know the impact of cancer.  In 1999 I lost my mother to colon cancer two days after losing my father to pancreatic cancer.  I was only 35 years old. At the time, there were very few treatments for these cancers, and today, these diseases remain among the top killers of Americans from Cancer. In fact, many do not realize that Colon Cancer is the second leading cause of cancer death in the U.S. with 1.2 million Americans living with the disease and 1 out of 20 getting it in their lifetime. Pancreatic cancer is one of the fastest growing, and most deadly cancers in the US. Cancer is an epidemic in this country affecting 1 out of every 2 men and 1 out of every 3 women. These two diseases alone account for more than 20 billion dollars in treatment costs annually.

While we wish that preventative methods alone were sufficient to defeat colon cancer, this is currently not the case.  Biologic medicines offer such promise and enable patients to live longer, healthier lives.  Since the introduction of biologic medicines, the average life expectancy of the metastatic colon cancer patient has almost tripled. Because these medicines have been shown to significantly improve the survivorship rates, the Global Colon Cancer Alliance has a vested interest in seeing biosimilar medicines introduced to the U.S. market. Lower cost medications means more access and more lives saved.

Yet we recognize the inherent safety challenges associated with this class of medicines and therefore, the issue of substitution has been a new challenge for policy-makers, such as you.

As you know, biologics are highly complex, advanced prescription medicines.  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.

That is why the Global Colon Cancer Alliance appreciates the opportunity to contribute a patient-centered viewpoint to the discussion regarding the biosimilar regulatory pathway.  In October of 2012, the Alliance for Safe Biologic Medicines (ASBM) released key principles that should be included in any formal policy recommendation.  As a founding Member of ASBM and an active Steering Committee member, we support these principles and believe that building policy around these common sense recommendations will help ensure patient safety without delaying the introduction of biosimilars.  We support the measures in HB746 because they track the ASBM principles by endorsing substitution of biosimilars as long as:

(1) The biosimilar product has been determined by the United States Food and Drug Administration to be interchangeable with the prescribed product for the indicated use.

(2) The prescriber does not designate verbally or in writing on the prescription that substitution is prohibited.

(3) The person presenting the prescription provides written consent for such substitution.

(4) The pharmacist notifies the prescriber in writing and as soon as practicable but no later than 72 hours after dispensing.

(5) The pharmacy and the prescriber retain a written record of the biosimilar substitution for a period of no less than five years

This legislation enhances the communication between pharmacists and physicians ensuring that doctors and pharmacists share a awareness for the exact medicine being taken, a practice that is especially important when it involves biologics.  This is a best practice and not much different than the process pharmacist practice today to ensure that patients are receiving the medicines that will serve them most effectively when they fill their prescriptions. We’ve come a long way in providing access to lifesaving drugs to colon cancer patients.  We want to ensure that these efforts continue as biosimilars are introduced and above all else, we must ensure that patient safety and welfare is the priority.  The last thing a cancer patient should have to worry about is the quality and safety of drugs prescribed by their physician. It is the patient’s right to know, and the physician’s duty to know when a biosimilar has been substituted for a prescribed biologic.

Thank you for taking the necessary steps to make patient safety a priority in Pennsylvania. We have supported the FDA in its mission to safely bring biosimilars to the U.S. and we support your efforts in my home state of Pennsylvania with HB 746.

 


IAPO Mexico City Meeting Includes Discussion on Biosimilars

September 23, 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.


IAPO Mexico City Meeting Includes Discussion on Biosimilars

September 23, 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 20, 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.

# # #

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


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

September 20, 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.

# # #

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


July – August / Summer 2013 Newsletter

August 27, 2013

Dolinar Authors Second Letter to WHO on Naming

ASBM Chairman Richard Dolinar, M.D., submitted a letter on July 31, 2013, to Dr. Margaret Chan, World Health Organization Director-General to reiterate ASBM’s position on the importance of using distinct non-proprietary names to ensure patient safety. The letter was sent to Dr. Chan and to the INN Expert Group, Department of Essential Medicines & Health Products, and the Health Systems & Innovation Division at the WHO in advance of their upcoming 57th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances to be held in Geneva on October 22, 2013.

Read letter here.

In addition to the letter to Dr. Chan, ASBM also formally requested to participate in the October 22nd meeting in Geneva.


Biosimilars Legislative Update – California

While most U.S. state legislative sessions have died down for the summer, California is nearing the finish line to pass vital patient safety legislation concerning biosimilars.

Senate Bill 598 has received a favorable position in the California Assembly, passing the Health Committee; the Business, Professions and Consumer Protection Committee; and the Appropriations Committee by favorable margins. The bill was considered by the full Assembly Monday, August 26th and passed with an overwhelming vote of 58-4. It now returns to the Senate for hopeful completion before the CA session ends on September 13th.


Global Colon Cancer Alliance Joins IAPO

ASBM Steering Committee member, Global Colon Cancer Alliance (GCCA) has officially joined the International Alliance of Patients’ Organizations (IAPO). IAPO is a global alliance of over 200 patients’ organizations representing 50 disease areas and over 60 countries worldwide. IAPO works in a creative and innovative way towards its vision of patient-centered healthcare and has a network that connects over 4,000 organizations and an estimated 365 million patients worldwide. GCCA will now officially be part of a larger, international network providing new opportunities to speak on colon cancer issues and well as share their thoughts on biosimilars.


IAPO to Discuss Biosimilars at Mexico City Regional Meeting

IAPO’s Governing Board Member, Eva Maria Ruiz de Castilla, will feature a discussion on biosimilars during IAPO’s upcoming Latin American Multi-Stakeholder Seminar, September 23rd in Mexico City. The seminar will continue to advance IAPO’s primary mission which is to inform and engage patient groups so that they can better advocate for patient-centered policies worldwide. The Mexico City event serves 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. The Geneva workshop brought together 19 patients’ organizations and other healthcare stakeholders from around the world to discuss what biosimilars are and what they mean to patients. ASBM Executive Director Michael Reilly and GCCA Co-Executive Director Andy Spiegel presented at the Geneva Workshop and are planning to attend the Mexico City seminar as well.


NALEO to Focus on Biosimilars at Legislative Summit

The National Association of Latino Elected and Appointed Officials (NALEO) is hosting their Legislative Summit on Health, October 25-27 in Las Vegas, NV. The October summit will focus on The Patient Protection and Affordable Care Act and will include a session focused on biosimilars.

NALEO is the nation’s leading non-profit organization that facilitates the full participation of Latinos in the American political process. Currently, NALEO represents more than 6,000 Latino elected and appointed officials and conducts advocacy on issues important to their community.


Australia Releases Guidance on Biosimilars

Building on similar European documents, Australia’s Therapeutic Goods Administration (TGA) recently released guidance to help drugmakers identify the data necessary to support the registration of biosimilars, in-Pharma Technologist reports. The TGA clarifies the scientific and regulatory requirements needed to bring biosimilars to the Australian market, which includes that manufacturers have to provide evidence that they have established in-house reference standards comparable to the reference biologic.

Read full article here.


AADA’s Board of Directors Updates Position on Biosimilars

ASBM Steering Committee member, American Academy of Dermatology, has formally updated their position statement on biosimilars. The Board of Directors approved changes on August 3rd. Those changes are based on a better understanding of legislation under consideration in many of the U.S. states, as well as the FDA’s possible approach in approving and regulating biosimilars. Specifically, the Board has included that “the pharmacist notifies the prescriber in writing or electronic communication by the time of dispensing.”

To view full statement click here.


IFPMA Launches New Publication on the Scientific & Regulatory Considerations of Biosimilars

The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) has recently published, “Similar Biotherapeutic Products – Scientific & Regulatory Considerations”. The piece includes a visual timeline of the development and manufacturing process of these products, as well as a unique illustration of how the biotech process works. Furthermore, the publication explains the science behind biotherapeutics and how they are not the same as chemically-synthesized molecules, which have a simpler chemical structure. This in-depth, yet easy to digest, publication helps to explain the concerns of the quality, safety, and efficacy issues faced in manufacturing biologics and in any biosimilar product.

Access publication here.


Upcoming DIA Conferences You Won’t Want to Miss

The Drug Information Association (DIA) will soon be hosting two forums on biologics in the Greater Washington, DC area.

The Development of Live Biotherapeutics: September 24, Hilton- Washington DC, Rockville, MD. This conference is set to provide a better understanding of the unique opportunities and challenges in the development of live biotherapeutics that will enable more translational research to move forward into therapeutics.

Click here for more information.

DIA Biosimilars 2013: November 13-14, Hyatt Regency, Bethesda, MD. This seminar is focused on supporting the growing sector of biosimilars. The meeting will focus on the challenges, innovations and technologies surrounding biosimilars.

Click here for more information.


ASBM Newsletter Now Available on the Web

ASBM newsletters are now on the web! All newsletters for the 2013 calendar year have been posted for easier reference and to share the exciting activities of ASBM. This one-stop update can be accessed on the bottom right-hand corner of the homepage or under the media toolbar. Join us in sharing this link with other allies in your community.

Click here to see the ASBM newsletter section.


ASBM Authors Second Letter to WHO on Naming

August 26, 2013

ASBM Chairman Richard Dolinar, MD recently submitted another letter on naming to the World Health Organization Director-General, Dr. Margaret Chan, as well as the INN Expert Group, Department of Essential Medicines & Health Products, and the Health Systems & Innovation division at WHO.  The second letter is a result of ASBM’s keen interst in the 56th Consultaion on International Nonproprietary Names (INN) for Pharmaceutical Substances, which was held in May,  as well as the positive feedback ASBM received from Dr. Raffaella Balocco, INN Program Manager.

Read letter here.

 


ASBM Authors Second Letter to WHO on Naming

August 26, 2013

ASBM Chairman Richard Dolinar, MD recently submitted another letter on naming to the World Health Organization Director-General, Dr. Margaret Chan, as well as the INN Expert Group, Department of Essential Medicines & Health Products, and the Health Systems & Innovation division at WHO.  The second letter is a result of ASBM’s keen interst in the 56th Consultaion on International Nonproprietary Names (INN) for Pharmaceutical Substances, which was held in May,  as well as the positive feedback ASBM received from Dr. Raffaella Balocco, INN Program Manager.

Read letter here.

 


American Academy of Dermatology Updates Biosimilar Statement

August 15, 2013

This month, the AADA’s Board of Directors approved an updated version of their position statement on biosimilars.  The AADA specifically adds new language to clarify physician notification by pharmacists. Read full statement here.


American Academy of Dermatology Updates Biosimilar Statement

August 15, 2013

This month, the AADA’s Board of Directors approved an updated version of their position statement on biosimilars.  The AADA specifically adds new language to clarify physician notification by pharmacists. Read full statement here.


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