Posts – Page 50 – Safe Biologics

ASBM Conducts CE Course for Pharmacists in CA

June 2, 2015

On May 29, 2015, in partnership with the Chapman University School of Pharmacy, ASBM held a Continuing Education course for roughly 40 pharmacists entitled “BIOSIMILARS: WHAT EVERY PHARMACIST SHOULD KNOW” at Chapman’s campus in Irvine, CA.

Following a brief baseline quiz to determine the participants’ understanding of biologics and biosimilars, four presentations were given by ASBM as part of a 3-credit hour course accredited by the California Pharmacists Association:

ASBM executive director Michael Reilly covered the history of U.S. biosimilar regulation, emphasizing on legislative definitions and FDA guidance, along with the broad strokes of ASBM’s activities serving as a resource for physician, patient and pharmacist perspectives for regulators in the U.S. and internationally. View his presentation here.

ASBM advisory board chair Dr. Philip Schneider covered the scientific differences between biologics and chemical medicines, illustrating how the size and complexity of these molecules, along with their sensitivity and lability, pose unique challenges including the possibility of immune response, and require special care in handling and preparation. The importance of clear identification of two similar biologics was emphasized from a pharmacist perspective, and possible solutions to this need (random or meaningful suffixes, prefixes, NDC codes, BQ) were discussed. The value of clear labeling was emphasized and identified as critical for pharmacists. Dr. Schneider also discussed the reason he co-authored a letter to the FDA calling for transparent biosimilar labeling. View his presentation here.

ASBM chairman Dr. Harry Gewanter then shared survey data reflecting physicians views on the importance of transparency in medicines, including the value of distinguishable names and a transparent label. Dr. Gewanter spoke about the value, hope, and opportunity that biologic medicines have brought to his patients, emphasizing that biosimilars will add to their legacy and increase access as well. However, he cautioned that physicians must gain confidence in biosimilars through data and transparency. Dr. Gewanter also stressed the need for timely physician-physician communication in cases of biosimilar substitution. View his presentation here.

Finally, Dr. Schneider discussed the evolution and current status of biosimilar substitution legislation in the U.S. He stressed the common ground between physicians and pharmacists, and value of cooperation and collaboration with physicians for general purposes of patient safety and pharmacovigilance. View his presentation here.

Following the course, an informal survey was conducted to measure the participants’ attitudes toward biosimilar naming. The results showed that the pharmacists in attendance were extremely supportive of distinguishable naming:

When asked “As a pharmacist, how important is it for me to be able to clearly distinguish between two similar biologic medicines?” 90% of respondents replied “Very Important or Critical”.
When presented with the statement “A biosimilar should have a name that allows it to be clearly distinguishable from the innovator or reference product to which it is similar.” 93% agreed with this statement.

Physician Confidence Critical to Biosimilar Adoption, Says Panel

June 1, 2015

SAN DIEGO, CA- On May 28, 2015 a panel discussion was held that examined the perspectives of innovator companies, biosimilar manufacturers, biotechnology reporters, and the health provider community on the topic of biosimilar development and marketing. The panel was held in as part of the World Biosimilar Congress 2015.

ASBM chairman Dr.Harry Gewanter provided the physician/patient perspective. Alex Waldron, VP of Global Commercial Operations for biosimilar manufacturer Epirus Pharmaceuticals; and Rakesh Dixit, VP of Research & Development and Global Head of Biologics Safety Assessment for innovator biologic company MedImmune, provided the perspectives of their industries. The panel was moderated by Bloomberg analysts Elizabeth Krutoholow and Aude Gerspacher, who released the results of a Bloomberg survey. The Bloomberg survey asked many diverse stakeholders in the biosimilars discussion about trends in the biosimilars market. Among the survey’s findings:

Respondents overwhelmingly agreed that the most important guidance issued by FDA would be that regarding Interchangeability.
55% of respondents expected that biosimilars will have the same INN as their reference product with a batch number of biological qualifier.
When asked to estimate potential savings from biosimilars relative to innovator products, this was estimated to be in the 20%-40% range by the majority (71%) of respondents.

During the panel discussion, Dr. Gewanter presented the physician perspective– that transparency/clarity in naming and for purposes of identification and pharmacovigilance was an essential component of patient safety that should trump cost considerations- which was largely echoed by Rakesh Dixit of MedImmune, while Mr. Waldron of Epirus Pharmaceuticals challenged this view, suggesting that potential safety risks to patients need to be balanced against the potential benefits of increased access and potential savings to payers.

Dr. Gewanter’s presentation on physician perspectives was well received by the audience, which numbered around 70 attendees. Dr. Dixit asked Dr. Gewanter if major biotech companies possessed a competitive advantage in biosimilar production, to which Dr. Gewanter posed the analogy of VIZIO brand televisions- a new market entrant with a discount price point which needed to prove its quality to consumers relative to more established, familiar, and trusted brands. When asked by an audience member why the U.S. should not simply copy the European approach, Dr. Gewanter replied that there were lessons to be learned from Europe’s mistakes as well as their successes, and that more data and transparency, particularly in naming and labeling was needed to build physician confidence. In addition to making a strong case for distinguishable naming, Dr. Gewanter spent several minutes on the subject of labeling, highlighting physician concerns with the lack of labeling transparency regarding Zarxio.

In a separate presentation, pharmacist Doug Monroe (Project Manager for Biotechnology, Emerging Technology, and Specialty Pharmacy for Kaiser Permanente) provided a payer perspective. Dr. Monroe emphasized the process taken by the Pharmacy and Therapeutics (P&T) Committees within his company, which he described as being based upon a totality of scientific evidence from varied sources such as the FDA, the biosimilar sponsor, published reports from journals, and the European biosimilars experience.

Despite their varied perspectives, all the participants agreed on one matter: that building physician confidence in biosimilars was critical to their successful adoption.

Physician Confidence Critical to Biosimilar Adoption, Says Panel

June 1, 2015

SAN DIEGO, CA- On May 28, 2015 a panel discussion was held that examined the perspectives of innovator companies, biosimilar manufacturers, biotechnology reporters, and the health provider community on the topic of biosimilar development and marketing. The panel was held in as part of the World Biosimilar Congress 2015.

ASBM chairman Dr.Harry Gewanter provided the physician/patient perspective. Alex Waldron, VP of Global Commercial Operations for biosimilar manufacturer Epirus Pharmaceuticals; and Rakesh Dixit, VP of Research & Development and Global Head of Biologics Safety Assessment for innovator biologic company MedImmune, provided the perspectives of their industries. The panel was moderated by Bloomberg analysts Elizabeth Krutoholow and Aude Gerspacher, who released the results of a Bloomberg survey. The Bloomberg survey asked many diverse stakeholders in the biosimilars discussion about trends in the biosimilars market. Among the survey’s findings:

Respondents overwhelmingly agreed that the most important guidance issued by FDA would be that regarding Interchangeability.
55% of respondents expected that biosimilars will have the same INN as their reference product with a batch number of biological qualifier.
When asked to estimate potential savings from biosimilars relative to innovator products, this was estimated to be in the 20%-40% range by the majority (71%) of respondents.

During the panel discussion, Dr. Gewanter presented the physician perspective– that transparency/clarity in naming and for purposes of identification and pharmacovigilance was an essential component of patient safety that should trump cost considerations- which was largely echoed by Rakesh Dixit of MedImmune, while Mr. Waldron of Epirus Pharmaceuticals challenged this view, suggesting that potential safety risks to patients need to be balanced against the potential benefits of increased access and potential savings to payers.

Dr. Gewanter’s presentation on physician perspectives was well received by the audience, which numbered around 70 attendees. Dr. Dixit asked Dr. Gewanter if major biotech companies possessed a competitive advantage in biosimilar production, to which Dr. Gewanter posed the analogy of VIZIO brand televisions- a new market entrant with a discount price point which needed to prove its quality to consumers relative to more established, familiar, and trusted brands. When asked by an audience member why the U.S. should not simply copy the European approach, Dr. Gewanter replied that there were lessons to be learned from Europe’s mistakes as well as their successes, and that more data and transparency, particularly in naming and labeling was needed to build physician confidence. In addition to making a strong case for distinguishable naming, Dr. Gewanter spent several minutes on the subject of labeling, highlighting physician concerns with the lack of labeling transparency regarding Zarxio.

In a separate presentation, pharmacist Doug Monroe (Project Manager for Biotechnology, Emerging Technology, and Specialty Pharmacy for Kaiser Permanente) provided a payer perspective. Dr. Monroe emphasized the process taken by the Pharmacy and Therapeutics (P&T) Committees within his company, which he described as being based upon a totality of scientific evidence from varied sources such as the FDA, the biosimilar sponsor, published reports from journals, and the European biosimilars experience.

Despite their varied perspectives, all the participants agreed on one matter: that building physician confidence in biosimilars was critical to their successful adoption.

ASBM Meets with Administration on Biosimilar Naming

May 21, 2015

WASHINGTON, DC- On Tuesday, May 19, 2015, ASBM met with Executive Branch officials to discuss the need for clear naming of biosimilars.

In attendance were officials from the Administration’s Office of Management and Budget (OMB), its Office of Information and Regulatory Affairs (OIRA), the National Economic Council (NEC), and the Department of Health and Human Services (HHS). ASBM was represented by its Chairman, pediatric rheumatologist Dr. Harry Gewanter; and its Executive Director, Michael S. Reilly.

Mr. Reilly described ASBM’s membership, and activities, and Dr. Gewanter provided a clinical perspective on the use of biologic medicines, focusing on the need for clear identification, tracking, and communication.

Dr. Gewanter praised the FDA’s use of distinguishable naming in its first biosimilar approval of Zarxio (filgrastim-sndz), calling the differentiating suffix “helpful”. Dr. Gewanter noted its similarity to the World Health Organization’s (WHO’s) own proposal for distinguishable naming, the Biological Qualifier (BQ)-in which a biosimilar’s International Nonproprietary Name (INN) would consist of a suffix of random letters appended to the INN of its reference product. Gewanter, who recently participated in the WHO’s 60th Consultation on International Nonproprietary Names in April, praised the WHO’s international approach to clear naming: “We need a clear label and INN is a good choice because the issue is a global issue.”

Mr. Reilly echoed the need to find a global, rather than local, solution to the issue of biosimilar naming, praising the WHO’s approach and emphasizing that transparency in naming was key to successfully building physician confidence in biosimilars.

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ASBM Meets with Administration on Biosimilar Naming

May 21, 2015

WASHINGTON, DC- On Tuesday, May 19, 2015, ASBM met with Executive Branch officials to discuss the need for clear naming of biosimilars.

In attendance were officials from the Administration’s Office of Management and Budget (OMB), its Office of Information and Regulatory Affairs (OIRA), the National Economic Council (NEC), and the Department of Health and Human Services (HHS). ASBM was represented by its Chairman, pediatric rheumatologist Dr. Harry Gewanter; and its Executive Director, Michael S. Reilly.

Mr. Reilly described ASBM’s membership, and activities, and Dr. Gewanter provided a clinical perspective on the use of biologic medicines, focusing on the need for clear identification, tracking, and communication.

Dr. Gewanter praised the FDA’s use of distinguishable naming in its first biosimilar approval of Zarxio (filgrastim-sndz), calling the differentiating suffix “helpful”. Dr. Gewanter noted its similarity to the World Health Organization’s (WHO’s) own proposal for distinguishable naming, the Biological Qualifier (BQ)-in which a biosimilar’s International Nonproprietary Name (INN) would consist of a suffix of random letters appended to the INN of its reference product. Gewanter, who recently participated in the WHO’s 60th Consultation on International Nonproprietary Names in April, praised the WHO’s international approach to clear naming: “We need a clear label and INN is a good choice because the issue is a global issue.”

Mr. Reilly echoed the need to find a global, rather than local, solution to the issue of biosimilar naming, praising the WHO’s approach and emphasizing that transparency in naming was key to successfully building physician confidence in biosimilars.

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Letters to FDA Praise Use of Distinguishable Biosimilar Naming, Urge Greater Label Transparency

May 13, 2015

On May 6, ASBM Chairman Harry Gewanter, M.D., sent a letter to Acting FDA Commissioner Stephen Ostroff, M.D, sharing ASBM’s recent survey on labeling and raising some concerns on the same issue.

Dr. Gewanter pointed out that the labeling for the recently approved biosimilar, Zarxio, falls short with the FDA’s longstanding emphasis on transparency and that clinically important product information is absent from the label. Dr. Gewanter said it is essential that the FDA include clear, appropriate and specific product labeling so patients and their healthcare team can make the best and most informed therapeutic decisions possible.

Read the letter here.

Physicians are not the only ones concerned with biosimilar labeling. On April 23, Philip Schneider, University of Arizona College of Pharmacy professor; Ronald P. Jordan, Chapman University School of Pharmacy Dean; and Joseph J. Bova, Long Island University College of Pharmacy Director of Continuing Education – the pharmacists that participated in continuing education class with ASBM – also sent a letter to Stephen Ostroff expressing concerns. Jordan is a former president of the American Pharmacist Association (APhA) and Schneider is a former president of the American Society of Health System Pharmacists (ASHP) and in the letter the pharmacists urged the FDA to consider a requirement for more informative labeling.

Read the letter here.

April 2015 Newsletter

May 7, 2015

WHO Meetings in Geneva

ASBM Chairman Harry Gewanter, M.D. and International Advisory Board Chair and pharmacist, Philip J. Schneider, M.S., F.A.S.H.P., jointly presented at the World Health Organization’s (WHO) 60^th International Nonproprietary Naming Stakeholders Session on April 13 in Geneva. The two provided perspectives from both a physician and pharmacist viewpoint and offered support for the WHO’s Biological Qualifier (BQ) proposal.

Both plan to attend the WHO’s “Front Page Meeting with INN Stakeholders” that will be held in Geneva on June 16. This meeting will show the results of the comment data analysis process on the “Biological Qualifier: An INN Proposal” document.

Pharmacists Raise Concerns on Labeling to FDA

On April 23, Philip Schneider, University of Arizona College of Pharmacy professor; Ronald P. Jordan, Chapman University School of Pharmacy Dean; and Joseph J. Bova, Long Island University College of Pharmacy Director of Continuing Education – the pharmacists that participated in the continuing education class with ASBM last month – sent a letter to Stephen Ostroff, M.D, Acting Commissioner of Food and Drug. Jordan is a former president of the American Pharmacist Association (APhA) and Schneider is a former president of the American Society of Health System Pharmacists (ASHP).

In the letter, they urged the FDA to consider a requirement for more informative labeling of biosimilars:

“Approval of these medicines is dependent on their meeting FDA’s thoughtfully-designed standards for safety and efficacy. Assuring the ready availability this information to prescribers and pharmacists will not only improve patient outcomes by promoting better-informed treatment decisions, it will serve to build overall confidence in biosimilars.“

Read the letter here.

Quintiles Podcast on First FDA Approval

Nigel Rulewski, M.D., Vice President of Global Strategic Drug Development and Head of Quintiles Global Biosimilars Unit, discussed the historic step the FDA took on March 6 approving the first ever biosimilar product for the U.S. market.

Listen to the podcast here.

ASBM Labeling Survey Featured in GaBI Article

The April 17 Generics and Biosimilars Initiative (GaBI) article, “Physicians’ views on biosimilars labeling,” quotes Executive Director Michael Reilly on the recently released physicians labeling survey. The piece highlights the key points from the survey and the physicians’ support for transparent, clear labels.

“ASBM Executive Director, Mr Michael Reilly stated that ‘we believe this data provides FDA with clear guideposts for what is necessary to foster physician confidence in biosimilar medicines.’ He added that ‘the survey was conducted prior to the first biosimilar approval and is more consistent with the draft guidance released in 2012 than the label of the first biosimilar product.’”

Read the full piece here.

In the States

Tennessee

Governor Haslam signed biosimilar legislation into law.

Georgia and Washington

Legislation has been passed and sent to the respective Governor to be signed.

California

On April 29, SB 671 was passed out of the Committee on Health and then sent to the Committee on Appropriations.

Louisiana

HB 319 passed the Health and Welfare Committee during the hearing on May 5. It scheduled for floor debate on May 14.

Maryland

The legislature in Annapolis adjourned on April 13 without passing SB 537.

Texas

SB 542 was referred to the Committee on Health and Human Services on April 21 and HB 751 passed the House as amended on April 14.

Upcoming Conferences:

May 27-28: USA World Biosimilars Congress 2015 in San Diego, CA
May 29: ASBM Pharmacist CE Class in Orange County, CA
June 1-4: Global Healthcare Conference in New York City, NY
June 14-18: DIA 2015 51st Annual Meeting in Washington, DC
June 16: WHO Front Page Meeting in Geneva

April 2015 Newsletter

May 7, 2015

WHO Meetings in Geneva

ASBM Chairman Harry Gewanter, M.D. and International Advisory Board Chair and pharmacist, Philip J. Schneider, M.S., F.A.S.H.P., jointly presented at the World Health Organization’s (WHO) 60^th International Nonproprietary Naming Stakeholders Session on April 13 in Geneva. The two provided perspectives from both a physician and pharmacist viewpoint and offered support for the WHO’s Biological Qualifier (BQ) proposal.

Both plan to attend the WHO’s “Front Page Meeting with INN Stakeholders” that will be held in Geneva on June 16. This meeting will show the results of the comment data analysis process on the “Biological Qualifier: An INN Proposal” document.

Pharmacists Raise Concerns on Labeling to FDA

On April 23, Philip Schneider, University of Arizona College of Pharmacy professor; Ronald P. Jordan, Chapman University School of Pharmacy Dean; and Joseph J. Bova, Long Island University College of Pharmacy Director of Continuing Education – the pharmacists that participated in the continuing education class with ASBM last month – sent a letter to Stephen Ostroff, M.D, Acting Commissioner of Food and Drug. Jordan is a former president of the American Pharmacist Association (APhA) and Schneider is a former president of the American Society of Health System Pharmacists (ASHP).

In the letter, they urged the FDA to consider a requirement for more informative labeling of biosimilars:

“Approval of these medicines is dependent on their meeting FDA’s thoughtfully-designed standards for safety and efficacy. Assuring the ready availability this information to prescribers and pharmacists will not only improve patient outcomes by promoting better-informed treatment decisions, it will serve to build overall confidence in biosimilars.“

Read the letter here.

Quintiles Podcast on First FDA Approval

Nigel Rulewski, M.D., Vice President of Global Strategic Drug Development and Head of Quintiles Global Biosimilars Unit, discussed the historic step the FDA took on March 6 approving the first ever biosimilar product for the U.S. market.

Listen to the podcast here.

ASBM Labeling Survey Featured in GaBI Article

The April 17 Generics and Biosimilars Initiative (GaBI) article, “Physicians’ views on biosimilars labeling,” quotes Executive Director Michael Reilly on the recently released physicians labeling survey. The piece highlights the key points from the survey and the physicians’ support for transparent, clear labels.

“ASBM Executive Director, Mr Michael Reilly stated that ‘we believe this data provides FDA with clear guideposts for what is necessary to foster physician confidence in biosimilar medicines.’ He added that ‘the survey was conducted prior to the first biosimilar approval and is more consistent with the draft guidance released in 2012 than the label of the first biosimilar product.’”

Read the full piece here.

In the States

Tennessee

Governor Haslam signed biosimilar legislation into law.

Georgia and Washington

Legislation has been passed and sent to the respective Governor to be signed.

California

On April 29, SB 671 was passed out of the Committee on Health and then sent to the Committee on Appropriations.

Louisiana

HB 319 passed the Health and Welfare Committee during the hearing on May 5. It scheduled for floor debate on May 14.

Maryland

The legislature in Annapolis adjourned on April 13 without passing SB 537.

Texas

SB 542 was referred to the Committee on Health and Human Services on April 21 and HB 751 passed the House as amended on April 14.

Upcoming Conferences:

May 27-28: USA World Biosimilars Congress 2015 in San Diego, CA
May 29: ASBM Pharmacist CE Class in Orange County, CA
June 1-4: Global Healthcare Conference in New York City, NY
June 14-18: DIA 2015 51st Annual Meeting in Washington, DC
June 16: WHO Front Page Meeting in Geneva

Pharmacist Letter to FDA on Labeling

May 3, 2015

On April 23, Philip Schneider, University of Arizona College of Pharmacy professor, Ronald P. Jordan, Chapman University School of Pharmacy Dean and Joseph J. Bova, Director of Continuing Education at the Long Island University College of Pharmacy, sent a letter to Stephen Ostroff, M.D, Acting Commissioner of Food and Drug, on their concerns on biosimilar labeling. Jordan is former president of the American Pharmacist Association (APhA) and Schneider is a former president of the American Society of Health System Pharmacists (ASHP) and together the three pharmacists urged the FDA to consider a requirement for more informative labeling of biosimilars.

Read the letter here.

GaBI: Physicians’ views on biosimilars labelling

April 20, 2015

On 23 March 2015, the Alliance for Safe Biologic Medicines (ASBM), which represents patients and physicians, as well as originator biological and biosimilars companies in the US, released results of a survey, which showed that physicians ‘support transparent, clear labels with data that enables prescribers to learn about and evaluate the medicines available to their patients’ [1].

The survey, which was carried out prior to the first biosimilar approval, questioned 400 US physicians about what they expected and wanted to see when it comes to biosimilars labelling. Specialists in dermatology, endocrinology, oncology, nephrology, neurology and rheumatology were included in the research, which was carried out via a web-based survey.

Read the full article here.