Safe Biologics

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.

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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.”

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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.

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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.

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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.

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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.

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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.

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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

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.

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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.

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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.

Lawmaker Presses FDA for Guidance on Naming, Interchangeability Policies

In a letter to FDA Commissioner Margaret Hamburg dated April 24, U.S. Rep. Anna Eshoo (D-CA) requested an update on FDA’s timeline for releasing guidance on biosimilar naming and interchangeability.

“I believe clear and timely guidance on naming and interchangeability will allow both innovators and manufacturers of biosimilars a predictable, science-based pathway to what will be a robust and competitive market for biologics”, Eshoo said.

Since the 2010 passage of the Biologics and Price Competition and Innovation Act (BPCIA) authorized it to create a biosimilar approval pathway, FDA has released draft guidance on demonstrating biosimilarity and other topics. Rep. Eshoo also requested an estimate from FDA on when this guidance, issued in 2012, would ultimately be finalized.

While regulatory authorities around the world have developed differing policies on biosimilar naming, and the World Health Organization (WHO) has proposed developing an international standard to harmonize these, the FDA has yet to take a position. On the issue of interchangeability, state legislatures find themselves crafting laws allowing pharmacists to substitute interchangeable biosimilars in place of the biologics being prescribed without the benefit of the FDA guidance outlining how interchangeability will be determined.

ASBM remains engaged on these issues with policymakers at both the international and state level. (see WHO and State Update sections below)

View Eshoo letter to FDA here.

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ASBM Presents at WHO 58th Consultation on International Nonproprietary Names (INN)

On April 8, ASBM Chairman Richard Dolinar, MD and Executive Director Michael S. Reilly, attended the World Health Organization’s 58th Consultation on International Nonproprietary Names (INN). ASBM spoke in support of a WHO proposal to assign a unique Biological Qualifier (BQ) to biosimilars, which would allow them to be distinguishable from their reference biologic.

“The goal of the INN is to ensure that the medicine which is prescribed is the medicine the patient receives. With biologics, we have a patchwork of regulatory attempts from many countries to deal with this problem, rather than one global solution. The proposed system would create an international standard allowing physicians, patients, pharmacists and regulators anywhere in the world to clearly identify which biologic medicine they are prescribing, dispensing, receiving or monitoring”, Dolinar said.

ASBM had previously commended the WHO for its leadership on the issue of distinguishable naming for biosimilars in a letter from Dr. Dolinar to the editors of The Generics and Biosimilars Initiative Journal (GaBI) in September of 2013. Additionally, ASBM presented its case for distinguishable nonproprietary names at the 57th INN, held in October of 2013.

Following that meeting, ASBM conducted a survey of 470 physicians in five European countries. ASBM’s European Prescriber Survey, the first of its kind in Europe, underscored the importance of distinguishable nonproprietary names:

24% of physicians surveyed ONLY report a medicine’s INN in the patient record, which could result in the patient receiving the wrong medicine.

17% of physicians surveyed report only the INN when reporting adverse events, which could lead to pooling of adverse events, false attribution, and other difficulties.

The value of distinguishable names, Dolinar emphasized, would not be limited to Europe: “For countries with a strong pharmacovigilance system, the BQ system may serve as a redundant safeguard that helps avoid a single point of information failure. For countries without such a system, it creates a consistent global standard for clarity and safety.”

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ASBM Presents EU Survey Findings and Policy Updates at FDLI Annual Conference

ASBM Executive Director, Michael Reilly joined Kimberly Greco of Amgen and Christopher Mikson, MD of Jones Day for a biologics panel at the Food and Drug Law Institute’s (FDLI) 57th Annual Conference on April 23rd in Washington, DC. The panel was moderated by John Manthei, partner, Latham & Watkins, who also gave a brief overview of the FDA’s progress implementing the BPCIA (Biosimilars Price Competition and Innovation Act).

The panel discussed the differences between chemically-based drugs and biologics, and how these differences impact interchangeability and pharmacy substitution laws in the U.S. and E.U.

To view Mr. Reilly’s presentation for the FDLI conference, click here.

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Implementation of French Biosimilar Substitution Law Emphasizes Differences from Chemical Drugs

A French law passed in January allowing biosimilar substitution in certain cases, is being mischaracterized as employing a “generics approach” to substitution. The law contains several patient protections which highlight that biologics, unlike generics, are not exact copies of their reference product.

First, the law states a biosimilar (approved by French health authority ANSM) may be dispensed only as an initial treatment to a new, or “naive” patient, and only if the physician has not stated that the prescribed biologic is “non-substitutable”. Patients currently receiving biologic treatments will remain unaffected by the law. When a substitution occurs, the pharmacist must inform the physician, and maintain records of the substitution.

In the U.S., where no biosimilars have yet been approved, legislation permitting a pharmacist to substitute a biosimilar in place of the physician-prescribed biologic has been widely debated at the state level.

European countries, however, have typically left treatment decisions to physicians and patients, avoiding “automatic substitution”. The European Medicines Agency (EMA) stated in 2012 “the physician should be in charge of the decision to switch between the reference and biosimilar, or vice versa.”

In an April interview with BioTechWatch, ASBM Executive Director Michael S. Reilly said he was encouraged by the French law’s recognition of the scientific reality that biosimilars are not identical to their reference biologic, and that physicians remain able to prevent a substitution, saying “physician-pharmacist communication and good record-keeping are absolutely vital for good pharmacovigilance”. Reilly expressed concern, however, with the law’s apparent creation of a two-tier system: “Each and every patient should be able to receive the medicine that works best for them, regardless of whether it is a biologic or a biosimilar.”

Details of the substitution policy must still be formalized by the ANSM and enacted by the Administrative Supreme Court, and substitution of biosimilars for affected patients will only begin after these decisions have been made.

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State Policy Update: Biosimilars Substitution Legislation in the U.S.

Illinois
On April 2nd, ASBM met with Illinois legislators in Springfield to urge them to support a biosimilar substitution bill for Illinois.

ASBM Chairman Richard Dolinar, MD gave an educational presentation to legislators entitled “Biologics and Biosimilars: Building Informed Policy at State Level” as part of the Discovering Cures Forum. The presentation emphasized the unique nature of biologics including their differences from chemical drugs, and offered physician perspectives on biosimilar substitution.

Citing ASBM’s 2012 survey of 376 physicians who prescribe biologics, Dolinar noted that 88% of physicians felt it “very important or critical” to be notified of any biologic substitution.

Delaware
On April 9th, the Senate in Delaware unanimously passed Senate Substitute 1 to Senate Bill 118 which authorizes pharmacists to dispense FDA approved interchangeable biosimilars for their prescribed biological reference product.

The original bill has been amended in accordance with similar language seen recently in other states, such as Indiana, and includes the physician’s signature for “substitution permitted” as well as facilitates the communication between the pharmacy and the physician within 10 days. The language also requires the pharmacist indicate both on the prescription and on the label the name of the manufacturer of the interchangeable biologic and maintain records for at least three years.

This legislation has passed the House Health and Human Development Committee 8-3, and is now moving to the House floor for a final vote. ASBM and other stakeholders continue to urge passage of this legislation.

To view ASBM letters to the DE House of Representatives, click here.

To view legislation, click here.

Texas
On April 14th, the House Committee on Public Health also heard testimony on the issue of biosimilars. The hearing was a result of a charge by Texas House of Representatives Speaker Joe Straus to the House Committee on Public Health. The committee was asked to study the issue of biologic substitution and interchangeability in order to make recommendations on what biosimilars legislation should address for next year’s session. Texas biosimilars legislation, SB 190, died on a point of order in the current session.

ASBM will continue to monitor these developments.

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BIOTECanada Joins ASBM

ASBM is pleased to announce BIOTECanada has officially joined the Alliance for Safe Biologic Medicines. BIOTECanada is an industry association with nearly 250 members located nation-wide reflecting the diverse nature of Canada’s health, industry, and agricultural biotechnology sectors.

“With the partnership of BIOTECanada, the Alliance for Safe Biologic Medicines continues to expand its global reach on the issues of patient safety and public policy surrounding biologic medications,” stated ASBM Executive Director, Michael Reilly. “BIOTECanada is a well-respected stakeholder in Canada and we are pleased to add such an influential international partner who will lend their voice to important conversations around the world surrounding biologic use and safety for patients.”

BIOTECanada and ASBM have enjoyed a strong relationship working closely on biosimilar issues in Canada. ASBM has been a participant in activities through BIOTECanada, most notably the “Regulator Forum on Biologic Naming and Traceability” hosted by Health Canada and BIOTECanada held in Ottawa last June.

To learn more about BIOTECanada, click here.

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Upcoming Conferences

June 15th-19th: DIA 50th Annual Meeting, San Diego Convention Center, CA
June 23rd-26th: BIO International Convention, San Diego, CA

Lawmaker Presses FDA for Guidance on Naming, Interchangeability Policies

In a letter to FDA Commissioner Margaret Hamburg dated April 24, U.S. Rep. Anna Eshoo (D-CA) requested an update on FDA’s timeline for releasing guidance on biosimilar naming and interchangeability.

“I believe clear and timely guidance on naming and interchangeability will allow both innovators and manufacturers of biosimilars a predictable, science-based pathway to what will be a robust and competitive market for biologics”, Eshoo said.

Since the 2010 passage of the Biologics and Price Competition and Innovation Act (BPCIA) authorized it to create a biosimilar approval pathway, FDA has released draft guidance on demonstrating biosimilarity and other topics. Rep. Eshoo also requested an estimate from FDA on when this guidance, issued in 2012, would ultimately be finalized.

While regulatory authorities around the world have developed differing policies on biosimilar naming, and the World Health Organization (WHO) has proposed developing an international standard to harmonize these, the FDA has yet to take a position. On the issue of interchangeability, state legislatures find themselves crafting laws allowing pharmacists to substitute interchangeable biosimilars in place of the biologics being prescribed without the benefit of the FDA guidance outlining how interchangeability will be determined.

ASBM remains engaged on these issues with policymakers at both the international and state level. (see WHO and State Update sections below)

View Eshoo letter to FDA here.

---

ASBM Presents at WHO 58th Consultation on International Nonproprietary Names (INN)

On April 8, ASBM Chairman Richard Dolinar, MD and Executive Director Michael S. Reilly, attended the World Health Organization’s 58th Consultation on International Nonproprietary Names (INN). ASBM spoke in support of a WHO proposal to assign a unique Biological Qualifier (BQ) to biosimilars, which would allow them to be distinguishable from their reference biologic.

“The goal of the INN is to ensure that the medicine which is prescribed is the medicine the patient receives. With biologics, we have a patchwork of regulatory attempts from many countries to deal with this problem, rather than one global solution. The proposed system would create an international standard allowing physicians, patients, pharmacists and regulators anywhere in the world to clearly identify which biologic medicine they are prescribing, dispensing, receiving or monitoring”, Dolinar said.

ASBM had previously commended the WHO for its leadership on the issue of distinguishable naming for biosimilars in a letter from Dr. Dolinar to the editors of The Generics and Biosimilars Initiative Journal (GaBI) in September of 2013. Additionally, ASBM presented its case for distinguishable nonproprietary names at the 57th INN, held in October of 2013.

Following that meeting, ASBM conducted a survey of 470 physicians in five European countries. ASBM’s European Prescriber Survey, the first of its kind in Europe, underscored the importance of distinguishable nonproprietary names:

24% of physicians surveyed ONLY report a medicine’s INN in the patient record, which could result in the patient receiving the wrong medicine.

17% of physicians surveyed report only the INN when reporting adverse events, which could lead to pooling of adverse events, false attribution, and other difficulties.

The value of distinguishable names, Dolinar emphasized, would not be limited to Europe: “For countries with a strong pharmacovigilance system, the BQ system may serve as a redundant safeguard that helps avoid a single point of information failure. For countries without such a system, it creates a consistent global standard for clarity and safety.”

---

ASBM Presents EU Survey Findings and Policy Updates at FDLI Annual Conference

ASBM Executive Director, Michael Reilly joined Kimberly Greco of Amgen and Christopher Mikson, MD of Jones Day for a biologics panel at the Food and Drug Law Institute’s (FDLI) 57th Annual Conference on April 23rd in Washington, DC. The panel was moderated by John Manthei, partner, Latham & Watkins, who also gave a brief overview of the FDA’s progress implementing the BPCIA (Biosimilars Price Competition and Innovation Act).

The panel discussed the differences between chemically-based drugs and biologics, and how these differences impact interchangeability and pharmacy substitution laws in the U.S. and E.U.

To view Mr. Reilly’s presentation for the FDLI conference, click here.

---

Implementation of French Biosimilar Substitution Law Emphasizes Differences from Chemical Drugs

A French law passed in January allowing biosimilar substitution in certain cases, is being mischaracterized as employing a “generics approach” to substitution. The law contains several patient protections which highlight that biologics, unlike generics, are not exact copies of their reference product.

First, the law states a biosimilar (approved by French health authority ANSM) may be dispensed only as an initial treatment to a new, or “naive” patient, and only if the physician has not stated that the prescribed biologic is “non-substitutable”. Patients currently receiving biologic treatments will remain unaffected by the law. When a substitution occurs, the pharmacist must inform the physician, and maintain records of the substitution.

In the U.S., where no biosimilars have yet been approved, legislation permitting a pharmacist to substitute a biosimilar in place of the physician-prescribed biologic has been widely debated at the state level.

European countries, however, have typically left treatment decisions to physicians and patients, avoiding “automatic substitution”. The European Medicines Agency (EMA) stated in 2012 “the physician should be in charge of the decision to switch between the reference and biosimilar, or vice versa.”

In an April interview with BioTechWatch, ASBM Executive Director Michael S. Reilly said he was encouraged by the French law’s recognition of the scientific reality that biosimilars are not identical to their reference biologic, and that physicians remain able to prevent a substitution, saying “physician-pharmacist communication and good record-keeping are absolutely vital for good pharmacovigilance”. Reilly expressed concern, however, with the law’s apparent creation of a two-tier system: “Each and every patient should be able to receive the medicine that works best for them, regardless of whether it is a biologic or a biosimilar.”

Details of the substitution policy must still be formalized by the ANSM and enacted by the Administrative Supreme Court, and substitution of biosimilars for affected patients will only begin after these decisions have been made.

---

State Policy Update: Biosimilars Substitution Legislation in the U.S.

Illinois
On April 2nd, ASBM met with Illinois legislators in Springfield to urge them to support a biosimilar substitution bill for Illinois.

ASBM Chairman Richard Dolinar, MD gave an educational presentation to legislators entitled “Biologics and Biosimilars: Building Informed Policy at State Level” as part of the Discovering Cures Forum. The presentation emphasized the unique nature of biologics including their differences from chemical drugs, and offered physician perspectives on biosimilar substitution.

Citing ASBM’s 2012 survey of 376 physicians who prescribe biologics, Dolinar noted that 88% of physicians felt it “very important or critical” to be notified of any biologic substitution.

Delaware
On April 9th, the Senate in Delaware unanimously passed Senate Substitute 1 to Senate Bill 118 which authorizes pharmacists to dispense FDA approved interchangeable biosimilars for their prescribed biological reference product.

The original bill has been amended in accordance with similar language seen recently in other states, such as Indiana, and includes the physician’s signature for “substitution permitted” as well as facilitates the communication between the pharmacy and the physician within 10 days. The language also requires the pharmacist indicate both on the prescription and on the label the name of the manufacturer of the interchangeable biologic and maintain records for at least three years.

This legislation has passed the House Health and Human Development Committee 8-3, and is now moving to the House floor for a final vote. ASBM and other stakeholders continue to urge passage of this legislation.

To view ASBM letters to the DE House of Representatives, click here.

To view legislation, click here.

Texas
On April 14th, the House Committee on Public Health also heard testimony on the issue of biosimilars. The hearing was a result of a charge by Texas House of Representatives Speaker Joe Straus to the House Committee on Public Health. The committee was asked to study the issue of biologic substitution and interchangeability in order to make recommendations on what biosimilars legislation should address for next year’s session. Texas biosimilars legislation, SB 190, died on a point of order in the current session.

ASBM will continue to monitor these developments.

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BIOTECanada Joins ASBM

ASBM is pleased to announce BIOTECanada has officially joined the Alliance for Safe Biologic Medicines. BIOTECanada is an industry association with nearly 250 members located nation-wide reflecting the diverse nature of Canada’s health, industry, and agricultural biotechnology sectors.

“With the partnership of BIOTECanada, the Alliance for Safe Biologic Medicines continues to expand its global reach on the issues of patient safety and public policy surrounding biologic medications,” stated ASBM Executive Director, Michael Reilly. “BIOTECanada is a well-respected stakeholder in Canada and we are pleased to add such an influential international partner who will lend their voice to important conversations around the world surrounding biologic use and safety for patients.”

BIOTECanada and ASBM have enjoyed a strong relationship working closely on biosimilar issues in Canada. ASBM has been a participant in activities through BIOTECanada, most notably the “Regulator Forum on Biologic Naming and Traceability” hosted by Health Canada and BIOTECanada held in Ottawa last June.

To learn more about BIOTECanada, click here.

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Upcoming Conferences

June 15th-19th: DIA 50th Annual Meeting, San Diego Convention Center, CA
June 23rd-26th: BIO International Convention, San Diego, CA