Andrew Spiegel Op-Ed Featured in Pittsburgh Post-Gazette

October 28, 2013

Allow ‘biosimilars’ in Pennsylvania
These medications will improve health and cut costs

The Pennsylvania Legislature is considering a measure to make sure patients have safe access to an important new class of drugs called “biosimilars.” If the bill passes, Pennsylvania will follow North Dakota, Oregon, Utah and Virginia in taking this critical legislative action.

“Biosimilars” are copycat versions of biological drugs, and the Food and Drug Administration is slated to begin approving these highly effective treatments next year. They’re expected to hit pharmacy shelves costing about 30 percent less than the brand-name medicines they’re based on. The benefits for patients, especially those suffering from cancer and other debilitating illnesses, could be enormous.

However, biosimilars do present some unique health risks. The immense chemical complexity that makes them so powerful can also, on occasion, generate adverse auto-immune responses. The Pennsylvania bill accounts for that medical reality and requires a simple, commonsense safeguard: Physicians and their patients should be notified in the event a pharmacist swaps out a prescribed biologic for its biosimilar alternative.

Unfortunately, critics have successfully framed this legislative push as nothing more than brand-name drug manufacturers using the power of law to block generic competition. They say notification would arouse patients’ suspicions and make them nervous to take low-cost biosimilars, causing many to opt for the more expensive brand-name treatments.

Not true. The bill is based in good science. It wouldn’t dictate the treatment protocols of doctors. It wouldn’t constrain the availability of biosimilars. And it wouldn’t dissuade patients from choosing viable low-cost options. All this legislation would do is provide people with the information they need to make good health care decisions.

Unlike chemical pharmaceuticals, biological medicines are constructed from living material. They typically replace or modify the natural activity of substances native to the human body, such as enzymes, hormones or antibodies. As a result, biologics can be considerably more effective than the pills in your medicine cabinet.

These advanced medicines are particularly important in the fight against cancer. By selectively targeting specific aspects of cancer cells, biologics kill fewer healthy cells and minimize toxic side effects. Some even help develop the red and white blood cells critical to a healthy immune system.

At the Global Colon Cancer Alliance, we assist more than 600,000 patients each year through awareness and support programs. So we’re eager to see copycat biologics hit the market.

In the United States, cancer is the cause of nearly a quarter of all deaths. Colon cancer is the second most deadly form. More than 150,000 Americans are diagnosed with the disease annually and more than 50,000 will die from it. Cutting-edge biologics offer those suffering from this and other forms of cancer new treatment options and improved hope for survival – but only if they are administered safely and accurately.

Biologics are so powerful because they are so much more complicated than traditional treatments. The average biologic molecule is about 1,000 times larger than a molecule from a typical chemical drug. Biologics are so profoundly complex that it’s effectively impossible to make an exact duplicate.

A traditional pharmaceutical is produced via a straightforward manufacturing process with clear chemical reactions. Biological drugs, on the other hand, are synthesized under often indeterminate conditions and the precise mechanism of their therapeutic effects is often poorly understood. So, unlike traditional generics, biosimilars are not exact copies of the brand-name drugs they’re based on. There will always be some slight differences.

For most patients, those differences don’t impact the drug’s therapeutic effect. However, for some these structural variations could cause adverse health consequences. The same rules that govern dispensing generic drugs won’t provide sufficient patient safeguards for biosimilars.

This is why the commonsense substitution rules being considered by state leaders make sense. If doctors are promptly and properly informed, they can evolve treatment regimens accordingly if any adverse outcomes arise. It’s all about patient safety.

Biosimilars have enormous potential to improve health and cut costs. The bill now before the Pennsylvania Legislature would establish a basic level of consumer protection without hindering the ability of patients to freely and widely access these drugs. Pennsylvania must pass this critical legislation.

Andrew Spiegel is a co-founder and co-chair of the Global Colon Cancer Alliance (www.global
cca.org).

ASBM Presents at WHO Meeting on Naming in Geneva

October 22, 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

ASBM Presents at WHO Meeting on Naming in Geneva

October 22, 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

Global Colon Cancer Association testifies before the Indiana Health Finance Commission

October 22, 2013

On Oct 22, 2013, Andrew Spiegel, Executive Director of the Global Colon Cancer Association, testified in support of biosimilar legislation under consideration in IN.

Indiana Health Finance Commission-GCCA Testimony

Global Colon Cancer Association testifies before the Indiana Health Finance Commission

October 22, 2013

On Oct 22, 2013, Andrew Spiegel, Executive Director of the Global Colon Cancer Association, testified in support of biosimilar legislation under consideration in IN.

Indiana Health Finance Commission-GCCA Testimony

September 2013 Newsletter

October 10, 2013

Dolinar Letter to the Editor Published by GaBI in Advance of WHO Naming Meeting

On September 27th, a Letter to the Editor by ASBM Chairman Richard Dolinar, M.D. was featured in the Generics and Biosimilars Initiative Journal (GaBI). The piece commends the World Health Organization (WHO) for its attention to an upcoming action on the issue of non-proprietary names for biologic medicines.

In the article, Dolinar writes, “WHO has shown thoughtful leadership in facilitating the further development of effective biological identification via a unique and universally available designated name for each pharmaceutical substance.  This action is very timely in light of the growing number of biosimilars and non-biocomparables arriving on the market.”

The letter also points to recent action by Australia’s Therapeutic Goods Administration (TGA) which has already moved forward on WHO’s version for biologicals and biosimilars naming conventions.

GaBI aims to raise the scientific status of generic and biosimilar medicines, and to provide comprehensive, high quality, scientifically sound, reliable, well-documented and up-to-date information about generic and biosimilar medicines both in print and electronically in an open access format.

To read Dolinar’s full Letter to the Editor, click here.

ASBM Set to Attend 57th WHO INN Consultation

Dr. Dolinar and ASBM Executive Director, Michael Reilly, are set to attend the World Health Organization’s 57th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances held October 22nd in Geneva.

There has been considerable interest recently on the importance of this meeting worldwide as the biologics debate moves forward and other countries seek to develop appropriate pathways. ASBM plans to further advocate at the WHO stakeholders meeting on the importance of using distinct non-proprietary names to ensure patient safety.

ASBM has issued two letters this year directly to the WHO in advance of the meeting.  Furthermore, both Dr. Dolinar and Mr. Reilly have met with Dr. Balocco, INN Program Director, at the HeathCanada/BiotechCanada Naming forum hosted this summer.

To read ASBM letters to the WHO, click here.

IAPO Mexico City Meeting Includes Discussion on Biosimilars

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.

Stateside: Biosimilars Legislative Updates

California

Senate Bill 598, legislation updating California’s pharmacy law, was sent to Governor Jerry Brown after passage of both chambers in the State Legislature by favorable margins. The legislation creates a safe process for the substitution of FDA approved interchangeable biologic medicines by ensuring the proper communication between pharmacist and physicians is taking place.  It requires physician notification of switches and gives doctors the ability to indicate ‘do not substitute’ on medications for their patients.  Appropriate record keeping is also required by the pharmacist for the ability to track and trace any potential adverse reactions in patients.

Patient groups are advocating for Governor Brown to sign SB 598 before the October 13th deadline. Without such legislation, patients in California would not have access to biosimilars or any potential benefits they may bring.

Pennsylvania

On September 11th, the Pennsylvania House of Representatives Health Committee hosted a hearing on HB 746, biosimilars legislation.

At the hearing, Chairman Matthew Baker and other committee members heard from a number of stakeholders who support HB 746.

Andrew Spiegel gave testimony in support of the bill and discussed why its passage will benefit patients with colon cancer. Other ASBM members, including the Global Healthy Living Foundation, were in attendance.

Read Andrew Spiegel’s testimony here.

Indiana

The Indiana Senate Health Finance Committee will hold a hearing on Tuesday, October 22nd in Indianapolis to discuss biosimilars substitution practices in their state.

On October 14th, in advance of the Senate hearing, Discovering Cures Indiana and the Indiana Health Industry Forum are hosting an educational event on biosimilars at the Indiana University Innovation Center.

Discovering Cures Indiana and the Indiana Health Industry Forum want to ensure leaders in their state are properly educated on the complexities of biologics and biosimilars and the need for changes to current practices to make sure patient safety is preserved. Their core concerns are to ensure transparency and maintain the primacy of the physician-patient relationship when developing public policy.

Forum panelist will include Dr. Richard Dolinar of ASBM, as well as the Biotechnology Industry Organization (BIO), policy makers and other patient advocates.

See the IN invite here.

NALEO to Welcome Dr. Dolinar as Key Speaker on Biosimilars

On October 26th in Las Vegas, Dr. Richard Dolinar will be the luncheon speaker at the National Association of Latino Elected and Appointed Officials (NALEO) Legislative Summit on Health.  Over forty state legislators from across the United States are planning on being in attendance.  While the NALEO summit will focus on the sum of the Patient Protection and Affordable Care Act, Dr. Dolinar will speak on the science and policy issues surrounding the FDA’s approval of biosimilars for patient use.

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.

September 2013 Newsletter

October 10, 2013

Dolinar Letter to the Editor Published by GaBI in Advance of WHO Naming Meeting

On September 27th, a Letter to the Editor by ASBM Chairman Richard Dolinar, M.D. was featured in the Generics and Biosimilars Initiative Journal (GaBI). The piece commends the World Health Organization (WHO) for its attention to an upcoming action on the issue of non-proprietary names for biologic medicines.

In the article, Dolinar writes, “WHO has shown thoughtful leadership in facilitating the further development of effective biological identification via a unique and universally available designated name for each pharmaceutical substance.  This action is very timely in light of the growing number of biosimilars and non-biocomparables arriving on the market.”

The letter also points to recent action by Australia’s Therapeutic Goods Administration (TGA) which has already moved forward on WHO’s version for biologicals and biosimilars naming conventions.

GaBI aims to raise the scientific status of generic and biosimilar medicines, and to provide comprehensive, high quality, scientifically sound, reliable, well-documented and up-to-date information about generic and biosimilar medicines both in print and electronically in an open access format.

To read Dolinar’s full Letter to the Editor, click here.

ASBM Set to Attend 57th WHO INN Consultation

Dr. Dolinar and ASBM Executive Director, Michael Reilly, are set to attend the World Health Organization’s 57th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances held October 22nd in Geneva.

There has been considerable interest recently on the importance of this meeting worldwide as the biologics debate moves forward and other countries seek to develop appropriate pathways. ASBM plans to further advocate at the WHO stakeholders meeting on the importance of using distinct non-proprietary names to ensure patient safety.

ASBM has issued two letters this year directly to the WHO in advance of the meeting.  Furthermore, both Dr. Dolinar and Mr. Reilly have met with Dr. Balocco, INN Program Director, at the HeathCanada/BiotechCanada Naming forum hosted this summer.

To read ASBM letters to the WHO, click here.

IAPO Mexico City Meeting Includes Discussion on Biosimilars

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.

Stateside: Biosimilars Legislative Updates

California

Senate Bill 598, legislation updating California’s pharmacy law, was sent to Governor Jerry Brown after passage of both chambers in the State Legislature by favorable margins. The legislation creates a safe process for the substitution of FDA approved interchangeable biologic medicines by ensuring the proper communication between pharmacist and physicians is taking place.  It requires physician notification of switches and gives doctors the ability to indicate ‘do not substitute’ on medications for their patients.  Appropriate record keeping is also required by the pharmacist for the ability to track and trace any potential adverse reactions in patients.

Patient groups are advocating for Governor Brown to sign SB 598 before the October 13th deadline. Without such legislation, patients in California would not have access to biosimilars or any potential benefits they may bring.

Pennsylvania

On September 11th, the Pennsylvania House of Representatives Health Committee hosted a hearing on HB 746, biosimilars legislation.

At the hearing, Chairman Matthew Baker and other committee members heard from a number of stakeholders who support HB 746.

Andrew Spiegel gave testimony in support of the bill and discussed why its passage will benefit patients with colon cancer. Other ASBM members, including the Global Healthy Living Foundation, were in attendance.

Read Andrew Spiegel’s testimony here.

Indiana

The Indiana Senate Health Finance Committee will hold a hearing on Tuesday, October 22nd in Indianapolis to discuss biosimilars substitution practices in their state.

On October 14th, in advance of the Senate hearing, Discovering Cures Indiana and the Indiana Health Industry Forum are hosting an educational event on biosimilars at the Indiana University Innovation Center.

Discovering Cures Indiana and the Indiana Health Industry Forum want to ensure leaders in their state are properly educated on the complexities of biologics and biosimilars and the need for changes to current practices to make sure patient safety is preserved. Their core concerns are to ensure transparency and maintain the primacy of the physician-patient relationship when developing public policy.

Forum panelist will include Dr. Richard Dolinar of ASBM, as well as the Biotechnology Industry Organization (BIO), policy makers and other patient advocates.

See the IN invite here.

NALEO to Welcome Dr. Dolinar as Key Speaker on Biosimilars

On October 26th in Las Vegas, Dr. Richard Dolinar will be the luncheon speaker at the National Association of Latino Elected and Appointed Officials (NALEO) Legislative Summit on Health.  Over forty state legislators from across the United States are planning on being in attendance.  While the NALEO summit will focus on the sum of the Patient Protection and Affordable Care Act, Dr. Dolinar will speak on the science and policy issues surrounding the FDA’s approval of biosimilars for patient use.

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.

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.

 

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.

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