Massachusetts Governor Signs Pharmacy Legislation Creating a Pathway for Biosimilars

June 24, 2014

Arlington, VA – Today, Governor Deval Patrick enacted biosimilars legislation updating Massachusetts’s pharmacy law and paving the way for the substitution of biosimilars deemed ‘interchangeable’ by the Food and Drug Administration (FDA).  The Governor took such action after swift passage of HB 3724 in both chambers of the General Court of the Commonwealth of Massachusetts.

As a physician, I applaud the Governor and the legislature for taking action to maintain the careful checks and balances needed in administering biologics,” stated Richard Dolinar, M.D., chairman of the Alliance for Safe Biologic Medicines (ASBM).  Unlike chemical drugs, biologics are complex medicines treating complicated conditions.  For that reason, regulations are needed to ensure doctors have a complete knowledge of what medicines are administered to their patients.  I feel confident that this new law strikes the right balance in maintaining the safety and efficacy of biologic products, while advancing more treatment options to patients.”

Biosimilars, or copies that are similar to but not exact versions of the original biologic, are expected to be approved by the FDA as early as 2015.  While the FDA will deem whether a biologic drug is approved and ‘interchangeable’, it is up to the states to decide whether one product may be substituted at the pharmacy level in place of the original biologic prescribed.

This new law allows pharmacists to substitute a biosimilar for a brand biologic once the biosimilar is deemed to be ‘interchangeable’.  The pharmacists would be required to communicate that a substitution has occurred both to the patient, as well as the prescribing physician.  Importantly, physicians would also maintain the right to prohibit substitutions from occurring if the prescriber instructs otherwise in writing.  The pharmacy will be required to maintain a record of each substitution for a period of at least a year.

Massachusetts is the third state this year to pass biosimilars legislation and pave the way for the substitution of biosimilars.  This creates a model for other states to follow in order to  address the necessary level of pharmacovigilance, while also promoting the use of these life-enhancing medicines.

“By ensuring that communication between physicians, pharmacists and patients remains a priority, we can monitor these complex therapies while providing the best quality and care,” concluded Dolinar.  We commend Governor Patrick for taking the necessary steps to protect this balance for patients in Massachusetts.”

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Massachusetts Governor Signs Pharmacy Legislation Creating a Pathway for Biosimilars

June 24, 2014

Arlington, VA – Today, Governor Deval Patrick enacted biosimilars legislation updating Massachusetts’s pharmacy law and paving the way for the substitution of biosimilars deemed ‘interchangeable’ by the Food and Drug Administration (FDA).  The Governor took such action after swift passage of HB 3724 in both chambers of the General Court of the Commonwealth of Massachusetts.

As a physician, I applaud the Governor and the legislature for taking action to maintain the careful checks and balances needed in administering biologics,” stated Richard Dolinar, M.D., chairman of the Alliance for Safe Biologic Medicines (ASBM).  Unlike chemical drugs, biologics are complex medicines treating complicated conditions.  For that reason, regulations are needed to ensure doctors have a complete knowledge of what medicines are administered to their patients.  I feel confident that this new law strikes the right balance in maintaining the safety and efficacy of biologic products, while advancing more treatment options to patients.”

Biosimilars, or copies that are similar to but not exact versions of the original biologic, are expected to be approved by the FDA as early as 2015.  While the FDA will deem whether a biologic drug is approved and ‘interchangeable’, it is up to the states to decide whether one product may be substituted at the pharmacy level in place of the original biologic prescribed.

This new law allows pharmacists to substitute a biosimilar for a brand biologic once the biosimilar is deemed to be ‘interchangeable’.  The pharmacists would be required to communicate that a substitution has occurred both to the patient, as well as the prescribing physician.  Importantly, physicians would also maintain the right to prohibit substitutions from occurring if the prescriber instructs otherwise in writing.  The pharmacy will be required to maintain a record of each substitution for a period of at least a year.

Massachusetts is the third state this year to pass biosimilars legislation and pave the way for the substitution of biosimilars.  This creates a model for other states to follow in order to  address the necessary level of pharmacovigilance, while also promoting the use of these life-enhancing medicines.

“By ensuring that communication between physicians, pharmacists and patients remains a priority, we can monitor these complex therapies while providing the best quality and care,” concluded Dolinar.  We commend Governor Patrick for taking the necessary steps to protect this balance for patients in Massachusetts.”

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Dr. Dolinar Presents at DIA Annual Conference

June 19, 2014

On June 19th, ASBM Chairman Richard Dolinar, MD presented at the Drug Information Agency’s (DIA) 50th Annual Meeting in San Diego, California.

 “Trends in Biosimilars Regulation Within Developed and Emerging Markets” was an assessment of current debates within the regulatory landscape of biosimilars.  Dr. Dolinar participated on a panel moderated by Andrew Robertson, Director of U.S. Regulatory Policy at Merck and panelist Sonica Sachdeva, Director of Clinical Development at Dr. Reddy’s Laboratory, India.

Dr. Dolinar shared the results of the ASBM European Prescriber Survey while advocating for distinguishable non-proprietary names for biosimilars.  Dr. Sachdeva reviewed how biologics and biosimilars are regulated in Eastern Asia.

View presentation here.


Dr. Dolinar Presents at DIA Annual Conference

June 19, 2014

On June 19th, ASBM Chairman Richard Dolinar, MD presented at the Drug Information Agency’s (DIA) 50th Annual Meeting in San Diego, California.

 “Trends in Biosimilars Regulation Within Developed and Emerging Markets” was an assessment of current debates within the regulatory landscape of biosimilars.  Dr. Dolinar participated on a panel moderated by Andrew Robertson, Director of U.S. Regulatory Policy at Merck and panelist Sonica Sachdeva, Director of Clinical Development at Dr. Reddy’s Laboratory, India.

Dr. Dolinar shared the results of the ASBM European Prescriber Survey while advocating for distinguishable non-proprietary names for biosimilars.  Dr. Sachdeva reviewed how biologics and biosimilars are regulated in Eastern Asia.

View presentation here.


ASBM Shares EU Survey Results at Paris Media Briefing

June 10, 2014

Michael Reilly, Executive Director of the Alliance for Safe Biologic Medicines, (ASBM) was featured as an expert panelist at “Understanding Biologic Medicine: Science, Regulatory Policy and the Changing Dynamics of Biosimilars”, a media briefing hosted by AbbVie on June 10th in Paris, France.

ASBM Executive Director Michael Reilly and Steering Committee Member Andrew Speigel participate in a panel discussion on global biologics policy.
ASBM Executive Director Michael Reilly and Steering Committee Member Andrew Spiegel participate in a panel discussion on global biologics policy.

The two-part event was webcast worldwide and featured a discussion on the scientific and regulatory challenges presented by biologics and biosimilars. Mr. Reilly presented the results of the ASBM EU Physician Survey, and also participated in a panel discussion with ASBM Steering Committee member and Co-Chair of the Global Colon Cancer Association, Andrew Spiegel.

Mr. Reilly’s presentation can be viewed here.


May 2014 Newsletter

June 6, 2014

GaBI Publishes ASBM Whitepaper on European Prescriber Survey

On June 5, The Generics and Biosimilars Initiative Journal published a paper authored by ASBM’s Chairman Richard Dolinar, MD and its Executive Director Michael Reilly.

The paper is based on data collected by ASBM for its 2013 survey of 470 prescribing physicians with clinical experience using biologics and biosimilars. Respondents included specialists from five Western European countries: the United Kingdom, France, Germany, Italy, and Spain.

The responses demonstrated a need for further education about the nature of biosimilars, and underscored the need for biosimilars to have distinguishable nonproprietary names from their reference products.

Of the physicians surveyed, 53 percent mistakenly believed an identical nonproprietary name implies identical structure; and 61 percent said that identical nonproprietary names imply that the medicines are approved for the same indications, which may not be the case.

Additionally, 24 percent of respondents said they recorded only the nonproprietary name of the biological product in the patient record. Without unique nonproprietary names to distinguish biosimilars from their reference products, this could result in pooling of adverse events, misattribution, and other difficulties.

The survey was conducted in November of 2013, and its results were presented by ASBM to the World Health Organization as part of its 58th Consultation on International Nonproprietary Names in April.

View GaBI paper here.


Delaware Governor Signs Biosimilars Substitution Bill

On May 28, Governor Jack Markell enacted legislation updating Delaware’s pharmacy law and paving the way for the safe substitution of biosimilars deemed ‘interchangeable’ by the Food and Drug Administration (FDA). The Governor took such action after overwhelming votes in both the State House and Senate and with much participation from ASBM members.

Senate Substitute 1 to Senate Bill 118, which authorizes pharmacists to dispense FDA approved interchangeable biosimilars for their prescribed biological reference product, contains the appropriate balance of safeguards by facilitating communication between physician and pharmacist, as well as outlines recordkeeping of transactions. Specifically, pharmacists are to communicate to the patient that a substitution has been made, and also notify the prescribing physician within a period of 10 days. The physician would maintain the right to prohibit substitutions from occurring if in the best interests of their patient. Pharmacists are also to record vital labeling and manufacturing information to ensure the proper track and trace procedures, and keep these records for a period of three years.

ASBM and its membership were extremely active in the legislative process in Delaware, by presenting compelling patient testimony, sending in statements of support and conducting one-on-one meetings with legislators. Andy Spiegel, Co-Chair of the Global Colon Cancer Association, also participated in a meeting with the Governor at which he was able to share important ASBM physician survey data.

“By ensuring communication between physicians, pharmacists and patients remains a priority, we can safely monitor these complex therapies while providing the best quality and care,” concluded Richard Dolinar, MD, Chair of the Alliance for Safe Biologic Medicines. “We commend Governor Markell and the General Assembly for taking the necessary steps to protect Delaware patients and advance more treatment options.”


New FDA Guidance Issued on Clinical Pharmacology Data

This month, the FDA released its fifth guidance document to continue to forge a pathway for biosimilars in the United States.

The guidance was published to assist companies in developing the appropriate databases, and utilization of modeling and simulations in the design of clinical trials for the approval of biosimilar medicines. While technical in nature, the document is said to be consistent with the advice FDA has been giving companies verbally on the clinical pharmacology data needed to demonstrate the biosimilarity of a biosimilar to its reference product. The guidance provides information about how to appropriately use data from products marketed outside the United States. Other countries, particularly the EU, have had biosimilars on the market for several years and may offer useful pharmacokinetic and pharmacodynamic data which could potentially be used to demonstrate biosimilarity.

The FDA continues to encourage companies looking to introduce biosimilars to engage in early conversations with the FDA in designing the appropriate studies to show that a proposed therapeutic biologic product is biosimilar to the original biologic.

View FDA Guidance Documents here.


SWHR Writes Letter to FDA on Naming, Gender Disparities

In a letter dated May 21 to FDA Commissioner, Margaret Hamburg, the Society for Women’s Health Research (SWHR) along with over 45 other organizations including some ASBM members, asked the FDA to consider gender disparities when it comes to biosimilars naming policies, as well as interchangeability and therapeutic substitution.

SWHR writes:

“As FDA finalizes critical policy issues relating to bringing the first biosimilars to market in the U.S. we ask that you give serious consideration to the impact of these policies on women’s health. Women are often underrepresented in clinical trials… Accordingly, the long-term effects and adverse reactions of biologics on female patients is not known. Distinguishable names will lead to better health outcomes for women by enabling the gathering of sufficient data to ultimately allow providers to fully understand how all biologics – including biosimilars – are performing for women.”

Read letter to the FDA here.


ASBM Invited to Share EU Survey Findings in Paris,
Webcast Around the Globe

On June 10, ASBM Executive Director Michael Reilly will be traveling to Paris to present the results of the ASBM European Prescriber Survey. The event, hosted by Abbvie, will be webcast across the world giving ASBM a chance to share its findings on the issues of naming, interchangeability and substitution of biosimilars.

ASBM’s European Prescriber Survey data remains first-of-it’s-kind results on physicians’ knowledge and experiences with biosimilar medicines. ASBM originally released the survey results in Brussels in March, but has also presented findings before the World Health Organization (WHO).

“It is important that regulatory bodies and those following this global discussion understand the careful balance that we must strike to continue to ensure the safety and efficacy of these medicines,” stated Mr. Reilly.


ASBM Set to Present at DIA Annual Conference

On June 19, ASBM Chairman Richard Dolinar, MD will present at the Drug Information Agency’s (DIA) 50th Annual Meeting that will be held in San Diego, California.

The session entitled, “Trends in Biosimilars Regulation Within Developed and Emerging Markets” will be an assessment of current debates within the regulatory landscape of biosimilars. Since Dr. Dolinar has just returned from presenting ASBM’s case for distinguishable nonproprietary names at the WHO’s 58th International Nonproprietary Naming (INN) Open Session convention held in April, he will speak first-hand on the emerging consensus around the naming of biosimilars and the potential use of biological qualifiers (BQ). In addition, Dolinar will share the results of the ASBM European Prescriber Survey which reflects the current thinking of physicians in the EU and underscored the importance of distinguishable nonproprietary names, as well as highlights areas of concern amongst substitution policies.

To learn more about the DIA Conference, click here.


Annual BIO Convention Features ASBM Members

On June 23-26, the Biotechnology Industry Organization (BIO) will host its International Convention in San Diego, CA.

This year’s convention will feature a panel of ASBM members including:
ASBM Steering Committee member Marcia Horn, President and CEO of the International Cancer Advocacy Network (ICAN); ASBM International Advisory Board member and Associate Dean of the University of Arizona College of Pharmacy, Phillip Schneider; and also ASBM International Advisory Board member, Robert Yapundich, MD.

The session entitled, “Ensuring the Safety and Commercial Success of Biosimilars in the United States,” will discuss how the United States can move forward to ensure patients have access to high quality, safe and effective biosimilars. Panelist will focus on the impact of international naming conventions, state substitution policies and other such issues facing regulators. It will also examine lessons learned from the European experience with biosimilars.

The BIO International Convention regularly draws over 15,000 attendees, and offers key networking and partnering opportunities, as well as provides insights on major trends affecting the industry.

For more information or to attend the BIO convention, click here.


National Psoriasis Foundation Joins ASBM

This May, the National Psoriasis Foundation (NPF), which is the voice for the 7.5 million Americans who are affected by psoriasis and psoriatic arthritis, joined the Alliance for Safe Biologic Medicines. NPF is the second organization to be added as a new member in the last few months, contributing to the growth of ASBM and its influence.

“ASBM is pleased to welcome the National Psoriasis Foundation and their patients as we continue to pursue the best solutions on biologic policy to ensure patients safe access to life-enhancing treatments. NPF represents the increasing population of individuals who are affected by biosimilars policies and we are pleased to add such a strong advocacy group to the ASBM ranks,” stated ASBM Executive Director, Michael Reilly.

NPF’s mission is to find a cure for psoriasis and psoriatic arthritis and to eliminate their devastating effects through research, advocacy and education. Through advocacy, the Psoriasis Foundation works to increase government investments in finding a cure, influence decision-makers to strengthen their focus on psoriasis and psoriatic arthritis and improve access to care.

To learn more about the National Psoriasis Foundation, click here.


May 2014 Newsletter

June 6, 2014

GaBI Publishes ASBM Whitepaper on European Prescriber Survey

On June 5, The Generics and Biosimilars Initiative Journal published a paper authored by ASBM’s Chairman Richard Dolinar, MD and its Executive Director Michael Reilly.

The paper is based on data collected by ASBM for its 2013 survey of 470 prescribing physicians with clinical experience using biologics and biosimilars. Respondents included specialists from five Western European countries: the United Kingdom, France, Germany, Italy, and Spain.

The responses demonstrated a need for further education about the nature of biosimilars, and underscored the need for biosimilars to have distinguishable nonproprietary names from their reference products.

Of the physicians surveyed, 53 percent mistakenly believed an identical nonproprietary name implies identical structure; and 61 percent said that identical nonproprietary names imply that the medicines are approved for the same indications, which may not be the case.

Additionally, 24 percent of respondents said they recorded only the nonproprietary name of the biological product in the patient record. Without unique nonproprietary names to distinguish biosimilars from their reference products, this could result in pooling of adverse events, misattribution, and other difficulties.

The survey was conducted in November of 2013, and its results were presented by ASBM to the World Health Organization as part of its 58th Consultation on International Nonproprietary Names in April.

View GaBI paper here.


Delaware Governor Signs Biosimilars Substitution Bill

On May 28, Governor Jack Markell enacted legislation updating Delaware’s pharmacy law and paving the way for the safe substitution of biosimilars deemed ‘interchangeable’ by the Food and Drug Administration (FDA). The Governor took such action after overwhelming votes in both the State House and Senate and with much participation from ASBM members.

Senate Substitute 1 to Senate Bill 118, which authorizes pharmacists to dispense FDA approved interchangeable biosimilars for their prescribed biological reference product, contains the appropriate balance of safeguards by facilitating communication between physician and pharmacist, as well as outlines recordkeeping of transactions. Specifically, pharmacists are to communicate to the patient that a substitution has been made, and also notify the prescribing physician within a period of 10 days. The physician would maintain the right to prohibit substitutions from occurring if in the best interests of their patient. Pharmacists are also to record vital labeling and manufacturing information to ensure the proper track and trace procedures, and keep these records for a period of three years.

ASBM and its membership were extremely active in the legislative process in Delaware, by presenting compelling patient testimony, sending in statements of support and conducting one-on-one meetings with legislators. Andy Spiegel, Co-Chair of the Global Colon Cancer Association, also participated in a meeting with the Governor at which he was able to share important ASBM physician survey data.

“By ensuring communication between physicians, pharmacists and patients remains a priority, we can safely monitor these complex therapies while providing the best quality and care,” concluded Richard Dolinar, MD, Chair of the Alliance for Safe Biologic Medicines. “We commend Governor Markell and the General Assembly for taking the necessary steps to protect Delaware patients and advance more treatment options.”


New FDA Guidance Issued on Clinical Pharmacology Data

This month, the FDA released its fifth guidance document to continue to forge a pathway for biosimilars in the United States.

The guidance was published to assist companies in developing the appropriate databases, and utilization of modeling and simulations in the design of clinical trials for the approval of biosimilar medicines. While technical in nature, the document is said to be consistent with the advice FDA has been giving companies verbally on the clinical pharmacology data needed to demonstrate the biosimilarity of a biosimilar to its reference product. The guidance provides information about how to appropriately use data from products marketed outside the United States. Other countries, particularly the EU, have had biosimilars on the market for several years and may offer useful pharmacokinetic and pharmacodynamic data which could potentially be used to demonstrate biosimilarity.

The FDA continues to encourage companies looking to introduce biosimilars to engage in early conversations with the FDA in designing the appropriate studies to show that a proposed therapeutic biologic product is biosimilar to the original biologic.

View FDA Guidance Documents here.


SWHR Writes Letter to FDA on Naming, Gender Disparities

In a letter dated May 21 to FDA Commissioner, Margaret Hamburg, the Society for Women’s Health Research (SWHR) along with over 45 other organizations including some ASBM members, asked the FDA to consider gender disparities when it comes to biosimilars naming policies, as well as interchangeability and therapeutic substitution.

SWHR writes:

“As FDA finalizes critical policy issues relating to bringing the first biosimilars to market in the U.S. we ask that you give serious consideration to the impact of these policies on women’s health. Women are often underrepresented in clinical trials… Accordingly, the long-term effects and adverse reactions of biologics on female patients is not known. Distinguishable names will lead to better health outcomes for women by enabling the gathering of sufficient data to ultimately allow providers to fully understand how all biologics – including biosimilars – are performing for women.”

Read letter to the FDA here.


ASBM Invited to Share EU Survey Findings in Paris,
Webcast Around the Globe

On June 10, ASBM Executive Director Michael Reilly will be traveling to Paris to present the results of the ASBM European Prescriber Survey. The event, hosted by Abbvie, will be webcast across the world giving ASBM a chance to share its findings on the issues of naming, interchangeability and substitution of biosimilars.

ASBM’s European Prescriber Survey data remains first-of-it’s-kind results on physicians’ knowledge and experiences with biosimilar medicines. ASBM originally released the survey results in Brussels in March, but has also presented findings before the World Health Organization (WHO).

“It is important that regulatory bodies and those following this global discussion understand the careful balance that we must strike to continue to ensure the safety and efficacy of these medicines,” stated Mr. Reilly.


ASBM Set to Present at DIA Annual Conference

On June 19, ASBM Chairman Richard Dolinar, MD will present at the Drug Information Agency’s (DIA) 50th Annual Meeting that will be held in San Diego, California.

The session entitled, “Trends in Biosimilars Regulation Within Developed and Emerging Markets” will be an assessment of current debates within the regulatory landscape of biosimilars. Since Dr. Dolinar has just returned from presenting ASBM’s case for distinguishable nonproprietary names at the WHO’s 58th International Nonproprietary Naming (INN) Open Session convention held in April, he will speak first-hand on the emerging consensus around the naming of biosimilars and the potential use of biological qualifiers (BQ). In addition, Dolinar will share the results of the ASBM European Prescriber Survey which reflects the current thinking of physicians in the EU and underscored the importance of distinguishable nonproprietary names, as well as highlights areas of concern amongst substitution policies.

To learn more about the DIA Conference, click here.


Annual BIO Convention Features ASBM Members

On June 23-26, the Biotechnology Industry Organization (BIO) will host its International Convention in San Diego, CA.

This year’s convention will feature a panel of ASBM members including:
ASBM Steering Committee member Marcia Horn, President and CEO of the International Cancer Advocacy Network (ICAN); ASBM International Advisory Board member and Associate Dean of the University of Arizona College of Pharmacy, Phillip Schneider; and also ASBM International Advisory Board member, Robert Yapundich, MD.

The session entitled, “Ensuring the Safety and Commercial Success of Biosimilars in the United States,” will discuss how the United States can move forward to ensure patients have access to high quality, safe and effective biosimilars. Panelist will focus on the impact of international naming conventions, state substitution policies and other such issues facing regulators. It will also examine lessons learned from the European experience with biosimilars.

The BIO International Convention regularly draws over 15,000 attendees, and offers key networking and partnering opportunities, as well as provides insights on major trends affecting the industry.

For more information or to attend the BIO convention, click here.


National Psoriasis Foundation Joins ASBM

This May, the National Psoriasis Foundation (NPF), which is the voice for the 7.5 million Americans who are affected by psoriasis and psoriatic arthritis, joined the Alliance for Safe Biologic Medicines. NPF is the second organization to be added as a new member in the last few months, contributing to the growth of ASBM and its influence.

“ASBM is pleased to welcome the National Psoriasis Foundation and their patients as we continue to pursue the best solutions on biologic policy to ensure patients safe access to life-enhancing treatments. NPF represents the increasing population of individuals who are affected by biosimilars policies and we are pleased to add such a strong advocacy group to the ASBM ranks,” stated ASBM Executive Director, Michael Reilly.

NPF’s mission is to find a cure for psoriasis and psoriatic arthritis and to eliminate their devastating effects through research, advocacy and education. Through advocacy, the Psoriasis Foundation works to increase government investments in finding a cure, influence decision-makers to strengthen their focus on psoriasis and psoriatic arthritis and improve access to care.

To learn more about the National Psoriasis Foundation, click here.


GaBI Publishes ASBM Whitepaper on European Prescriber Survey

June 5, 2014

On June 5, The Generics and Biosimilars Initiative Journal published a paper authored by ASBM’s Chairman Richard Dolinar, MD and its Executive Director Michael Reilly.

The paper is based on data collected by ASBM for its 2013 survey of 470 prescribing physicians with clinical experience using biologics and biosimilars. Respondents included specialists from five Western European countries: the United Kingdom, France, Germany, Italy, and Spain.

The responses demonstrated a need for further education about the nature of biosimilars, and underscored the need for biosimilars to have distinguishable nonproprietary names from their reference products.

Of the physicians surveyed, 53 percent mistakenly believed an identical nonproprietary name implies identical structure; and 61 percent said that identical nonproprietary names imply that the medicines are approved for the same indications, which may not be the case.

Additionally, 24 percent of respondents said they recorded only the nonproprietary name of the biological product in the patient record. Without unique nonproprietary names to distinguish biosimilars from their reference products, this could result in pooling of adverse events, misattribution, and other difficulties.

The survey was conducted in November of 2013, and its results were presented by ASBM to the World Health Organization as part of its 58th Consultation on International Nonproprietary Names in April.

View GaBI paper here.

 


GaBI Publishes ASBM Whitepaper on European Prescriber Survey

June 5, 2014

On June 5, The Generics and Biosimilars Initiative Journal published a paper authored by ASBM’s Chairman Richard Dolinar, MD and its Executive Director Michael Reilly.

The paper is based on data collected by ASBM for its 2013 survey of 470 prescribing physicians with clinical experience using biologics and biosimilars. Respondents included specialists from five Western European countries: the United Kingdom, France, Germany, Italy, and Spain.

The responses demonstrated a need for further education about the nature of biosimilars, and underscored the need for biosimilars to have distinguishable nonproprietary names from their reference products.

Of the physicians surveyed, 53 percent mistakenly believed an identical nonproprietary name implies identical structure; and 61 percent said that identical nonproprietary names imply that the medicines are approved for the same indications, which may not be the case.

Additionally, 24 percent of respondents said they recorded only the nonproprietary name of the biological product in the patient record. Without unique nonproprietary names to distinguish biosimilars from their reference products, this could result in pooling of adverse events, misattribution, and other difficulties.

The survey was conducted in November of 2013, and its results were presented by ASBM to the World Health Organization as part of its 58th Consultation on International Nonproprietary Names in April.

View GaBI paper here.

 


Society for Women’s Research Writes FDA on Gender Disparities Regarding Biosimilars Policies

May 21, 2014

In a letter dated May 21 to FDA Commissioner, Margaret Hamburg, the Society for Women’s Health Research (SWRA) along with over 40 other organizations, asked the FDA to consider gender disparities when it comes to biosimilars policies.

SWHR states:

“As FDA finalizes critical policy issues relating to bringing the first biosimilars to market in the U.S. we ask that you give serious consideration to the impact of these policies on women’s health.  Women are often underrepresented in clinical trials, and even when they are included clinical results are not routinely analyzed by sex. Accordingly, the long-term effects and adverse reactions of biologics on female patients is not known.

Distinguishable names will lead to better health outcomes for women by enabling the gathering of sufficient data to ultimately allow providers to fully understand how all biologics – including biosimilars – are performing for women.” 

To view letter to the FDA click here.


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