VIDEO: Autoimmune Patient Discusses Concerns with Non-Medical Switching

July 8, 2016

In this video, patient advocate Kathleen Arntsen, President and CEO of the Lupus and Allied Diseases Association (LADA) and an autoimmune patient herself, discusses the power of advocacy and her concerns with Non-Medical Switching (NMS).

NMS is the switching of a patient from one treatment to another, typically by a third party such as a Pharmacy Benefit Manager (PBM) or insurance company, for reasons other than a patient’s health and safety.

Unlike generic versions of chemical drugs, biosimilars are not identical to their reference products, and these differences can produce unexpected effects in patients, including unwanted and harmful immune responses. In the case of biologic treatments such as those used to treat autoimmune disorders, switching a patient (who may have worked for years to find a treatment that effectively manages his or her condition) can cause the patient to lose that hard-won stability.


VIDEO: Autoimmune Patient Discusses Concerns with Non-Medical Switching

July 8, 2016

In this video, patient advocate Kathleen Arntsen, President and CEO of the Lupus and Allied Diseases Association (LADA) and an autoimmune patient herself, discusses the power of advocacy and her concerns with Non-Medical Switching (NMS).

NMS is the switching of a patient from one treatment to another, typically by a third party such as a Pharmacy Benefit Manager (PBM) or insurance company, for reasons other than a patient’s health and safety.

Unlike generic versions of chemical drugs, biosimilars are not identical to their reference products, and these differences can produce unexpected effects in patients, including unwanted and harmful immune responses. In the case of biologic treatments such as those used to treat autoimmune disorders, switching a patient (who may have worked for years to find a treatment that effectively manages his or her condition) can cause the patient to lose that hard-won stability.


ASBM Promotes High Approval Standards, Memorable Names at DIA 2016

July 6, 2016

ASBM was an exhibitor during the 52nd Annual meeting of the Drug Information Association (DIA) held June 26th-30th in Philadelphia.

ASBM members and staff discussed biosimilars policy with attendees, including the need for the FDA to maintain high standards for safety and efficacy when approving biosimilars.

More than 65 attendees, including clinical researchers, physicians, pharmacists, patients, and regulators, filled out “Names Matter” postcards urging the FDA to adopt meaningful, memorable suffixes in future biosimilar approvals (as it did in its first approval) rather than random suffixes (as it did in its second).

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ASBM’s booth at DIA 2016

 

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ASBM’s Executive Director, Michael Reilly was in attendance and discussed biosimilar policy with other conference attendees.

 

 

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DIA 2016 attendees filled out postcards urging the FDA to adopt meaningful, memorable suffixes for biosimilars.

 

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John Lewis, VP of Communications for the Association of Clinical Research Organizations (ACRO), fills out a postcard.

 

 

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ASBM also promoted the benefits of meaningful, memorable biologic naming through multiple table advertisements in the refreshment area.

 


ASBM Presents at Latin American Forum on Biosimilars

July 6, 2016

On June 29th, ASBM Chairman Harry L. Gewanter, MD and ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, gave presentations at the 6th Latin American Forum on Biosimilars, held in Brasília, Brazil. The event was also the 7th Brazilian Forum on Biosimilars. The event was attended by more than 500 healthcare stakeholders, including patients, physicians, regulators and manufacturers.

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Dr. Gewanter presented data from ASBM’s survey of 399 Latin American prescribers of biologic medicines, on matters including biosimilar naming, labeling, and substitution.

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The survey found a need for education about biosimilars among the physicians surveyed, all of whom prescribe biologics. Only 12% of respondents considered themselves “very familiar” with biosimilars, with more than a third (35%) having never heard of them or being unable to define the term.

 

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Dr. Gewanter discussed two distinguishable biologic naming proposals by the FDA and World Health Organization (WHO) that would ensure clear product identification between similar medicines, allow an accurate patient record to be kept, and promote accurate tracking of adverse events.
The survey showed that 94% of respondents considered the WHO’s proposal, a four-letter suffix called a “biological qualifier” or BQ, “helpful” in ensuring their patients receive the correct medicine.

 

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Mr. Spiegel presented the patient perspective on biosimilars, emphasizing the need for high and consistent approval standards, transparency in labeling and during substitution, and the importance of  control of treatment decisions remaining between a patient and his healthcare team from whom he or she receives direct care.

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Mr. Spiegel cautioned against the non-medical switching of a patient’s medicine, arguing that there is no reason for a physician to switch a medicine that is working effectively for a patient. The patient’s health and safety should always be the primary consideration.

Dr. Gewanter’s presentation may be viewed here.

Mr. Speigel’s presentation may be viewed here.


ASBM Presents at Latin American Forum on Biosimilars

July 6, 2016

On June 29th, ASBM Chairman Harry L. Gewanter, MD and ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, gave presentations at the 6th Latin American Forum on Biosimilars, held in Brasília, Brazil. The event was also the 7th Brazilian Forum on Biosimilars. The event was attended by more than 500 healthcare stakeholders, including patients, physicians, regulators and manufacturers.

image005

Dr. Gewanter presented data from ASBM’s survey of 399 Latin American prescribers of biologic medicines, on matters including biosimilar naming, labeling, and substitution.

image008

The survey found a need for education about biosimilars among the physicians surveyed, all of whom prescribe biologics. Only 12% of respondents considered themselves “very familiar” with biosimilars, with more than a third (35%) having never heard of them or being unable to define the term.

 

IMG_2604

Dr. Gewanter discussed two distinguishable biologic naming proposals by the FDA and World Health Organization (WHO) that would ensure clear product identification between similar medicines, allow an accurate patient record to be kept, and promote accurate tracking of adverse events.
The survey showed that 94% of respondents considered the WHO’s proposal, a four-letter suffix called a “biological qualifier” or BQ, “helpful” in ensuring their patients receive the correct medicine.

 

image018

Mr. Spiegel presented the patient perspective on biosimilars, emphasizing the need for high and consistent approval standards, transparency in labeling and during substitution, and the importance of  control of treatment decisions remaining between a patient and his healthcare team from whom he or she receives direct care.

image012

Mr. Spiegel cautioned against the non-medical switching of a patient’s medicine, arguing that there is no reason for a physician to switch a medicine that is working effectively for a patient. The patient’s health and safety should always be the primary consideration.

Dr. Gewanter’s presentation may be viewed here.

Mr. Speigel’s presentation may be viewed here.


Lupus and Allied Diseases Association: Affordable access critical for care

June 18, 2016

Biosimilar drugs hold advantages for people like me, just as biologic medicines have for millions living with life-threatening and life-diminishing diseases. Access to appropriate medication can dramatically improve disease outcome and quality of life. As more biosimilars become available, we want to ensure they are safe and affordable. I strongly support S6311 and A8648A, which will create a new pathway for biologic substitution where none exists in New York.

Our immune response to treatments is unique and at times adverse. Since biosimilars are not precise replicas of the originator biologic and autoimmune patients are so hypersensitive that even the slightest change in manufacturing, dose or method of delivery can provoke an immune response and disease complications, patient safeguards must be established.

This legislation ensures the treating physician is aware of the exact biologic product, indicated by manufacturer, given to a patient in order to facilitate care and accurately attribute any adverse events.

Pharmacist-prescriber communication is paramount in identifying exactly which medicine was received if an adverse event occurs because biosimilars will be administered to individuals suffering from serious, life-threatening diseases.

S6311 and A8648A will facilitate communication between pharmacists, prescribers and patients. This legislation is timely given the U.S. Food & Drug Administration’s approval of the first two biosimilars and additional products in the pipeline. More than 20 states and Puerto Rico have already passed biosimilars legislation. It is imperative that these safeguards are put in place in New York state to provide the best medical care possible and that patients have access to life-changing therapies. I urge state legislators to support these bills.

Kathleen A. Arntsen

President and CEO,

Lupus and Allied Diseases Association Inc.

Verona, NY

Affordable access critical for care

 


Lupus and Allied Diseases Association: Affordable access critical for care

June 18, 2016

Biosimilar drugs hold advantages for people like me, just as biologic medicines have for millions living with life-threatening and life-diminishing diseases. Access to appropriate medication can dramatically improve disease outcome and quality of life. As more biosimilars become available, we want to ensure they are safe and affordable. I strongly support S6311 and A8648A, which will create a new pathway for biologic substitution where none exists in New York.

Our immune response to treatments is unique and at times adverse. Since biosimilars are not precise replicas of the originator biologic and autoimmune patients are so hypersensitive that even the slightest change in manufacturing, dose or method of delivery can provoke an immune response and disease complications, patient safeguards must be established.

This legislation ensures the treating physician is aware of the exact biologic product, indicated by manufacturer, given to a patient in order to facilitate care and accurately attribute any adverse events.

Pharmacist-prescriber communication is paramount in identifying exactly which medicine was received if an adverse event occurs because biosimilars will be administered to individuals suffering from serious, life-threatening diseases.

S6311 and A8648A will facilitate communication between pharmacists, prescribers and patients. This legislation is timely given the U.S. Food & Drug Administration’s approval of the first two biosimilars and additional products in the pipeline. More than 20 states and Puerto Rico have already passed biosimilars legislation. It is imperative that these safeguards are put in place in New York state to provide the best medical care possible and that patients have access to life-changing therapies. I urge state legislators to support these bills.

Kathleen A. Arntsen

President and CEO,

Lupus and Allied Diseases Association Inc.

Verona, NY

Affordable access critical for care

 


NY pharmacist: Help ensure access to life-changing treatments

June 8, 2016

Biologic medicines currently help millions of patients suffering from serious conditions like cancer, multiple sclerosis and rheumatoid arthritis. New medicines called biosimilars, which attempt to mimic the therapeutic properties of the original biologics, are becoming available. These will create new treatment options — and cost savings — for patients. But unlike generic versions of chemical drugs, biosimilars are not exact duplicates of their innovator drugs. Biologics are complex molecules grown within living cells, and an attempted copy can only be, as the term suggests – similar to its innovator drug, but never exactly the same.

This distinction is important, as doctors and pharmacists know, because even seemingly minor differences between two similar biologics can be the difference between helping a patient, or hurting them – sometimes severely – through unintended side effects such as unwanted immune responses.

Many states have prepared for biosimilars by passing legislation meant to ensure their safe prescribing and dispensing. More need to catch up, including New York, which has yet to adopt legislation addressing substitution of biologics at the pharmacy. Substitution is expected to bring cost savings for patients and the health care system, but policy must reflect that biosimilars are different from generics.

First, we need to ensure that only “interchangeable” biosimilars — those that the FDA has determined produce the same effects as the original product, without additional risks if a patient is switched between them — are ever substituted. While only one non-interchangeable biosimilar has been approved, FDA’a Dr. Janet Woodcock has predicted the approval of an interchangeable biosimilar by the end of 2016.

Even more important, we need to ensure clear and timely communication between pharmacists and physicians about the specific product received. Keeping accurate patient records and knowing what medicine patients actually receive is vital to accurately attributing adverse drug reactions, and tracking the long-term safety and efficacy of biologic medicines. This is especially important with biosimilars, which benefit from an abbreviated approval process. It also promotes manufacturer accountability for their products.

While communication between prescribers and pharmacists around substitution might seem intuitive, many states – including New York – don’t require it. Thus, legislatures across the country are passing laws reflecting the importance of this communication, and of recording substitutions, when dispensing biologics. In November of last year, our neighbors in New Jersey enacted such a law.

Legislators in Albany are now working extend these protections to New York’s patients by passing legislation that promotes transparency and communication between pharmacists, doctors and patients, so everyone knows which biologic is actually dispensed after one is prescribed.

The burden of educating legislators and urging them to act on this issue falls on the entire medical community, including pharmacists like me. I will continue educating my colleagues, doctors and the patients we serve about the importance of this issue. I hope New York legislators and my fellow pharmacists agree, and advocate accordingly.

Joe Bova, M.S., R.Ph, Director

Department of Continuing Education

Long Island University College of Pharmacy

 

http://liherald.com/stories/Help-ensure-access-to-life-changing-treatments,80535?


ASBM Presents to New York State Pharmacy Society

June 4, 2016

ASBM Presents to New York State Pharmacy Society 

On June 3rd, ASBM’s Advisory Board Chair Dr. Philip Schneider, Associate Dean at the University of Arizona’s College of Pharmacy, presented to the Pharmacy Society of the State of New York (PSSNY) at a forum held at the Albany College of Pharmacy.

Dr. Schneider discussed how biologics and chemical drugs differ in terms of size, complexity, and sensitivity and how biosimilars differ from generic versions of chemical drugs.

He also explained how policymakers are addressing these differences in regards to biosimilar naming, labeling and substitution policy and presented the perspectives of healthcare providers on these issues, with data drawn from ASBM’s surveys of US physicians and pharmacists and Continuing Education courses


ASBM Presents to New York State Pharmacy Society

June 4, 2016

ASBM Presents to New York State Pharmacy Society 

On June 3rd, ASBM’s Advisory Board Chair Dr. Philip Schneider, Associate Dean at the University of Arizona’s College of Pharmacy, presented to the Pharmacy Society of the State of New York (PSSNY) at a forum held at the Albany College of Pharmacy.

Dr. Schneider discussed how biologics and chemical drugs differ in terms of size, complexity, and sensitivity and how biosimilars differ from generic versions of chemical drugs.

He also explained how policymakers are addressing these differences in regards to biosimilar naming, labeling and substitution policy and presented the perspectives of healthcare providers on these issues, with data drawn from ASBM’s surveys of US physicians and pharmacists and Continuing Education courses


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