Posts – Page 30 – Safe Biologics

Physicians, Patients Overwhelmingly Support FDA Distinct Biologic Naming Plan, Suffixes for New Products

May 14, 2019

Physicians, Patients Overwhelmingly Support FDA Distinct Biologic Naming Plan, Suffixes for New Products

May 13, 2019

Arlington, VA – US physicians and patient advocacy organizations expressed their overwhelming support for the FDA’s suffix-based naming system for biologic medicines and biosimilars, according to comments electronically submitted last week to the agency.

Biologic medicines treat serious conditions including rheumatoid arthritis, psoriasis, and cancer. Lower-cost versions, called biosimilars, offer new therapeutic choices but unlike generics are not exact copies of the originator. These inherent differences spurred the FDA to implement a system of distinct suffixes to ensure clear product identification; the comment period on a recent update to the policy closed May 7^th.

Support for the recent update to the FDA policy was very strong and diverse. A joint letter of support was submitted by physician organizations including 24 national and state rheumatology associations and Harvard Medical School. Alliance for Safe Biologic Medicines (ASBM) was among the more than 100 patient advocacy organizations that submitted comments or signed on to letters of support for the policy, as did 124 individual patients, nurses, and other health care providers. A letter of support was also submitted from two past presidents of the American Pharmacists Association and the American Society of Health-system Pharmacists.

In addition to the submitted comments, results from a May 2019 survey of 202 biologic prescribers were shared with FDA; in which 85% said they “strongly agree” or “somewhat agree” with the FDA’s policy of adding 4-letter suffixes. Only 7% strongly or somewhat disagree with the policy, while 8% were “unsure”. Respondents were drawn equally from specialties in which biologics are routinely prescribed, including rheumatology, gastroenterology, endocrinology, oncology, dermatology, neurology, immunology, nephrology, and ophthalmology. The full survey may be viewed here.
Physicians were strongly supportive of recent updates to the FDA policy, including the decision not to retrospectively rename previously approved products with suffixes: 71% agreed with the FDA’s decision not to rename previously-approved biologics with suffixes, and 67% agreed with the FDA’s decision not to rename insulin, desirudin, and somatropin products previously approved under the Food Drug and Cosmetics Act.

“US physicians have once again spoken very clearly in support of the FDA and of distinct naming”, said Madelaine Feldman, MD FACR, Chairwoman of ASBM, who conducted the survey.

A minority of parties submitting comments to the FDA during the recent comment period opposed the FDA policy, including health insurance companies, national chain drug stores, and pharmacy benefit managers. Opponents of distinct naming submitted 17 individual comment letters and a joint comment letter with 29 signatories, compared to more than 250 organizations and individuals who wrote in directly or signed letters of support. Still other commenters supported distinct naming, but had comments on the suffix design or implementation. Biologic manufacturers varied widely in their support.

“Biosimilars offer patients increased access to life-changing therapies, at reduced cost for patients and our health system. In order to reap these benefits, physicians and patients need confidence that adverse events will be attributed to the correct product, be it originator or biosimilar. Physicians and patients have spoken clearly to FDA: distinct naming is essential to building that confidence”, said Dr. Feldman.

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About the Alliance for Safe Biologic Medicines

The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups including physicians, patients, pharmacists, manufacturers of innovator biologics and biosimilars, researchers, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. Visit us at www.SafeBiologics.org.

Media contact: Ray Patnaude media@safebiologics.org

April 2019 Newsletter

May 1, 2019

newsletter | April 2019

issue 77

Who We Are
The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe.

Our Perspective
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.

Contact Us

info@safebiologics.org

For media inquiries please contact: media@safebiologics.org

Alliance for Safe Biologic Medicines

PO Box 3691

Arlington, VA 22203

(703) 960-0601

Twitter: @SafeBiologics

Facebook

YouTube

Physicians, Patients Express Overwhelming Support for FDA Distinct Biologic Naming Plan
US physicians and patient advocacy organizations expressed their overwhelming support for the FDA’s suffix-based naming system for biologic medicines and biosimilars, according to comments electronically submitted last week to the agency.

Biologic medicines treat serious conditions including rheumatoid arthritis, psoriasis, and cancer. Lower-cost versions, called biosimilars, offer new therapeutic choices but unlike generics are not exact copies of the originator. These inherent differences spurred the FDA to implement a system of distinct suffixes to ensure clear product identification; the comment period on a recent update to the policy closed May 7th.

Support for the recent update to the FDA policy was very strong and diverse. A joint letter of support was submitted by physician organizations including 24 national and state rheumatology associations and Harvard Medical School.

ASBM was among the more than 100 patient advocacy organizations that submitted comments or signed on to letters of support for the policy, as did 124 individual patients, nurses, and other health care providers. A letter of support was also submitted from two past presidents of the American Pharmacists Association and the American Society of Health-system Pharmacists.
In addition to the submitted comments, results from a May 2019 survey of 202 biologic prescribers were shared with FDA; in which 85% said they “strongly agree” or “somewhat agree” with the FDA’s policy of adding 4-letter suffixes. Only 7% strongly or somewhat disagree with the policy, while 8% were “unsure”.
Physicians were strongly supportive of recent updates to the FDA policy, including the decision not to retrospectively rename previously approved products with suffixes: 71% agreed with the FDA’s decision not to rename previously-approved biologics with suffixes, and 67% agreed with the FDA’s decision not to rename insulin, desirudin, and somatropin products previously approved under the Food Drug and Cosmetics Act.
Respondents were drawn equally from specialties in which biologics are routinely prescribed, including rheumatology, gastroenterology, endocrinology, oncology, dermatology, neurology, immunology,
nephrology, and ophthalmology.

Read ASBM’s press release and about the comments and survey here.

The full survey may be viewed here.

FDA Finalizes Interchangeability Guidance
This month, the FDA finalized its guidance on the pathway for interchangeable biologics, which may be substituted without the involvement of the prescriber. From a statement by Acting FDA Commissioner Norman E. Sharpless, MD:
Today’s final guidance gives an overview of important scientific considerations in demonstrating interchangeability with a reference product and explains the scientific recommendations for an application or a supplement for a proposed interchangeable product. Once an application or supplement seeking licensure as an interchangeable product is submitted, the FDA will approve the biological product as interchangeable with the reference product if the information submitted in the application or the supplement is sufficient to meet the applicable statutory standard: among other things, that the biological product is biosimilar to the reference product and can be expected to produce the same clinical result as the reference product in any given patient. The guidance also explains potential ways to address the BPCI Act requirement for interchangeability that, for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product will not be greater than the risk of using the reference product without such alternation or switch.

Read the full FDA Statement here and the Final Guidance here.

FDA Approves 19th Biosimilar, Second for Etanercept

In late April, FDA approved Eticovo (etanercept-ykro), the second biosimilar for etanercept.

Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Etanercept is indicated for the treatment of rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.

Eticovo has been approved across all eligible indications, namely ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis and rheumatoid arthritis.

Read more about the FDA approval here.

ASBM Presents at 68th WHO INN Consultation

On April 2nd, ASBM Chair Madelaine Feldman, MD, FACR; and Advisory Board Chair, Philip Schneider, MS, FASHP presented before the 68th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the twelfth INN Consultation at which ASBM has presented since 2013.

While the discussions in the Open Session at which ASBM presented are bound by confidentiality agreements pending the publication of an Executive Summary by the INN Programme, the Executive Summary for the 67th INN Consultation may be viewed here.

ASBM surveys have consistently shown strong support for distinct naming among physicians worldwide. Sixty-six percent of U.S. physicians surveyed support distinct naming for all biologics including biosimilars, as do 68% of Canadian and 79% of Australian physicians. Among physicians in Latin America, 94% believe the WHO’s BQ proposal would be helpful in ensuring their patients receive the correct medicine.

In the past year, ASBM has held three meetings to discuss international harmonization of biologic nomenclature. Participants included representatives from the FDA, Health Canada, the WHO, physician and pharmacist societies, and patient advocacy organizations. The first two meetings took place in April and July 2018 in Washington, DC, and the third in March 2019 in Ottawa, Ontario. A white paper on the first of these meetings may be read here.

UPCOMING ASBM EVENTS

Digestive Disease Week

San Diego, CA – May 18-21

BIO International Convention

Philadelphia, PA – June 3-5

DIA Annual Meeting

San Diego, CA – June 23-27

April 2019 Newsletter

May 1, 2019

newsletter | April 2019

issue 77

Who We Are
The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe.

Our Perspective
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.

Contact Us

info@safebiologics.org

For media inquiries please contact: media@safebiologics.org

Alliance for Safe Biologic Medicines

PO Box 3691

Arlington, VA 22203

(703) 960-0601

Twitter: @SafeBiologics

Facebook

YouTube

Physicians, Patients Express Overwhelming Support for FDA Distinct Biologic Naming Plan
US physicians and patient advocacy organizations expressed their overwhelming support for the FDA’s suffix-based naming system for biologic medicines and biosimilars, according to comments electronically submitted last week to the agency.

Biologic medicines treat serious conditions including rheumatoid arthritis, psoriasis, and cancer. Lower-cost versions, called biosimilars, offer new therapeutic choices but unlike generics are not exact copies of the originator. These inherent differences spurred the FDA to implement a system of distinct suffixes to ensure clear product identification; the comment period on a recent update to the policy closed May 7th.

Support for the recent update to the FDA policy was very strong and diverse. A joint letter of support was submitted by physician organizations including 24 national and state rheumatology associations and Harvard Medical School.

ASBM was among the more than 100 patient advocacy organizations that submitted comments or signed on to letters of support for the policy, as did 124 individual patients, nurses, and other health care providers. A letter of support was also submitted from two past presidents of the American Pharmacists Association and the American Society of Health-system Pharmacists.
In addition to the submitted comments, results from a May 2019 survey of 202 biologic prescribers were shared with FDA; in which 85% said they “strongly agree” or “somewhat agree” with the FDA’s policy of adding 4-letter suffixes. Only 7% strongly or somewhat disagree with the policy, while 8% were “unsure”.
Physicians were strongly supportive of recent updates to the FDA policy, including the decision not to retrospectively rename previously approved products with suffixes: 71% agreed with the FDA’s decision not to rename previously-approved biologics with suffixes, and 67% agreed with the FDA’s decision not to rename insulin, desirudin, and somatropin products previously approved under the Food Drug and Cosmetics Act.
Respondents were drawn equally from specialties in which biologics are routinely prescribed, including rheumatology, gastroenterology, endocrinology, oncology, dermatology, neurology, immunology,
nephrology, and ophthalmology.

Read ASBM’s press release and about the comments and survey here.

The full survey may be viewed here.

FDA Finalizes Interchangeability Guidance
This month, the FDA finalized its guidance on the pathway for interchangeable biologics, which may be substituted without the involvement of the prescriber. From a statement by Acting FDA Commissioner Norman E. Sharpless, MD:
Today’s final guidance gives an overview of important scientific considerations in demonstrating interchangeability with a reference product and explains the scientific recommendations for an application or a supplement for a proposed interchangeable product. Once an application or supplement seeking licensure as an interchangeable product is submitted, the FDA will approve the biological product as interchangeable with the reference product if the information submitted in the application or the supplement is sufficient to meet the applicable statutory standard: among other things, that the biological product is biosimilar to the reference product and can be expected to produce the same clinical result as the reference product in any given patient. The guidance also explains potential ways to address the BPCI Act requirement for interchangeability that, for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product will not be greater than the risk of using the reference product without such alternation or switch.

Read the full FDA Statement here and the Final Guidance here.

FDA Approves 19th Biosimilar, Second for Etanercept

In late April, FDA approved Eticovo (etanercept-ykro), the second biosimilar for etanercept.

Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Etanercept is indicated for the treatment of rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.

Eticovo has been approved across all eligible indications, namely ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis and rheumatoid arthritis.

Read more about the FDA approval here.

ASBM Presents at 68th WHO INN Consultation

On April 2nd, ASBM Chair Madelaine Feldman, MD, FACR; and Advisory Board Chair, Philip Schneider, MS, FASHP presented before the 68th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the twelfth INN Consultation at which ASBM has presented since 2013.

While the discussions in the Open Session at which ASBM presented are bound by confidentiality agreements pending the publication of an Executive Summary by the INN Programme, the Executive Summary for the 67th INN Consultation may be viewed here.

ASBM surveys have consistently shown strong support for distinct naming among physicians worldwide. Sixty-six percent of U.S. physicians surveyed support distinct naming for all biologics including biosimilars, as do 68% of Canadian and 79% of Australian physicians. Among physicians in Latin America, 94% believe the WHO’s BQ proposal would be helpful in ensuring their patients receive the correct medicine.

In the past year, ASBM has held three meetings to discuss international harmonization of biologic nomenclature. Participants included representatives from the FDA, Health Canada, the WHO, physician and pharmacist societies, and patient advocacy organizations. The first two meetings took place in April and July 2018 in Washington, DC, and the third in March 2019 in Ottawa, Ontario. A white paper on the first of these meetings may be read here.

UPCOMING ASBM EVENTS

Digestive Disease Week

San Diego, CA – May 18-21

BIO International Convention

Philadelphia, PA – June 3-5

DIA Annual Meeting

San Diego, CA – June 23-27

ASBM Presents at 68th WHO INN Naming Consultation

April 2, 2019

On April 2nd, ASBM Chair Madelaine Feldman, MD, FACR; and Advisory Board Chair, Philip Schneider, MS, FASHP presented before the 68th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the twelfth INN Consultation at which ASBM has presented since 2013.

While the discussions in the Open Session at which ASBM presented are bound by confidentiality agreements pending the publication of an Executive Summary by the INN Programme, the Executive Summary for the 67th INN Consultation may be viewed here.

ASBM surveys have consistently shown strong support for distinct naming among physicians worldwide. Sixty-six percent of U.S. physicians surveyed support distinct naming for all biologics including biosimilars, as do 68% of Canadian and 79% of Australian physicians. Among physicians in Latin America, 94% believe the WHO’s BQ proposal would be helpful in ensuring their patients receive the correct medicine.

In the past year, ASBM has held three meetings to discuss international harmonization of biologic nomenclature. Participants included representatives from the FDA, Health Canada, the WHO, physician and pharmacist societies, and patient advocacy organizations. The first two meetings took place in April and July 2018 in Washington, DC, and the third in March 2019 in Ottawa, Ontario. A white paper on the first of these meetings may be read here.

March 2019 Newsletter

April 1, 2019

newsletter | March 2019

issue 75

Who We Are
The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe.

Our Perspective
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.

Contact Us

info@safebiologics.org

For media inquiries please contact: michael@safebiologics.org

Alliance for Safe Biologic Medicines

PO Box 3691

Arlington, VA 22203

(703) 971 – 1700

Twitter: @SafeBiologics

Facebook

YouTube

ASBM Exhibits at APhA Annual Meeting

From March 22nd-24th, ASBM exhibited at the Annual Meeting of the American Pharmacists Association (APhA), held in Seattle, Washington. Founded in 1852, APhA is the largest association of pharmacists in the United States, with more than 62,000 practicing pharmacists, pharmaceutical scientists, student pharmacists, and pharmacy technicians as members.
ASBM was represented at its booth by Advisory Board Chair Philip Schneider, past president of the American Society of Healthsystem Pharmacists (ASHP) and Advisory Board Member Ronald Jordan, Dean of the Chapman University College of Pharmacy and past president of APhA.
Dr. Schneider answered questions about biosimilar policy issues which affect pharmacy practice, including naming practices in the US and internationally. US biosimilar substitution policy, which varies by state, was also discussed.
Read more about ASBM’s APhA exhibit here.

Mississippi Becomes 46th State to Enact Biosimilar Substitution
Legislation

On March 21st, Mississippi Governor Phil Bryant signed Senate Bill 2365, making Mississippi the 46th U.S. State to enact legislation permitting pharmacists to substitute a biosimilar once approved by the FDA as interchangeable.

The law requires pharmacists to communicate to the prescriber within 5 business days which product- the reference or the biosimilar- was dispensed. This ensures that all parties maintain an accurate patient record, that physicians can accurately assess a patients’s response to a particular treatment, and can make informed decisions. Physicians also retain the authority to prevent a substitution they deem medically inappropriate.

On February 6th, ASBM Chair Madelaine Feldman participated in a briefing for Mississippi legislators to discuss the bill.

Read about the legislation here.

FDA Approves 18th Biosimilar, Fourth for Trastuzumab
On March 11th, the FDA granted approval to trastuzumab-qyyp (Trazimera), referencing trastuzumab (Herceptin). This is the fourth trastuzumab biosimilar approved in just 15 months. The first, trastuzumab-dkst (Ogiviri), was approved in December 2017.

Trastuzumab-qyyp is used to treat patients with HER-2 overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
Read more about the approval here.

FDA Releases Updated Draft Guidance on Biologic Naming
On March 7th, FDA released and updated Draft Guidance on the naming of biological products. According to the Guidance document, the FDA no longer intends to retroactively assign random 4-letter suffixes to existing biologics. The guidance states that the FDA will continue to assign suffixes to all new biologic products, innovator and biosimilar, as they are approved. Biosimilars which are later deemed interchangeable will retain their suffix.

ASBM released a statement is support of the updated guidance, which said in part:

ASBM commends the decision by FDA to apply distinguishable suffixes to all biologics, including interchangeable biosimilars going forward. FDA’s decision puts in place a protocol for a safe future, when there are many more biologics, biosimilars and interchangeable biosimilars.

The full statement may be read here.
The difficulties associated with applying distinguishing suffixes to previously-approved biologics were cited as a contributing factor to Health Canada’s recent decision not to harmonize nomenclature its with FDA’s system following extensive discussions.
However, the new guidance explains that the agency will continue to assign suffixes to newly approved innovator biologics, biosimilars, or interchangeable biosimilars. With regard to interchangeable biosimilars (those which can be substituted at the pharmacy level without physician involvement), the Agency made clear that an approved biosimilar’s suffix would not be changed should it subsequently be designated interchangeable.
Finally, FDA clarified its treatment of so-called “transition products”
including insulins, that were approved under the Section (505) of the Food, Drug and Cosmetic Act which will be deemed biosimilars as of March 23, 2020. These products also will not be renamed with new suffixes.
Read the full Guidance here.
Comments on the Guidance are due by May 7th and may be submitted here.

ASBM Meets with Health Canada, FDA and WHO to Discuss International Harmonization of Biologic Naming

On March 6th, 2019, ASBM hosted the third in a series of meetings with regulators to discussion the international harmonization of biologic nomenclature. Participants included representatives from Health Canada, the FDA, and the World Health Organization. Other participants included members of canadian physician and patient advocacy organizations from the disease states commonly treated with biologic medicines.

The meeting, held in Ottawa, Ontario served as a follow-up to prior meetings held during April and July in Washington, DC.
The April 11th meeting was the subject of a recent whitepaper prepared by Scientific American, which co-hosted the meeting.

ASBM Exhibits at APhA Annual Meeting

March 26, 2019

From March 22nd-24th, ASBM exhibited at the Annual Meeting and Expo of the American Pharmacists Association (APhA), held in Seattle, Washington.Founded in 1852, APhA is the largest association of pharmacists in the United States, with more than 62,000 practicing pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians as members.

ASBM was represented at its booth by Advisory Board Chair Philip Schneider, past president of the American Society of Healthsystem Pharmacists (ASHP) and Advisory Board Member Ronald Jordan, Dean of the Chapman University College of Pharmacy and past president of APhA.

Dr. Schneider answered questions about biosimilar policy issues which affect pharmacy practice, including naming practices in the US and internationally. US biosimilar substitution policy, which varies by state, was also discussed.

Educational videos targeted at pharmacists were also shown at the ASBM booth during the three-day exhibition. These included a video featuring Schneider and Jordan, and ASBM’s recently-released pharmacist videos on naming, interchangeability and substitution, and non-medical switching were also shown.

ASBM Statement Supporting Updated FDA Naming Guidance

March 12, 2019

ASBM commends the decision by FDA to apply distinguishable suffixes to all biologics, including interchangeable biosimilars, going forward. FDA’s decision puts in place a protocol for a safe future, when there are many more biologics, biosimilars and interchangeable biosimilars. This policy ensures that patients and health care providers can distinguish between products when that is important for a patient’s care or to report adverse events.

We understand FDA’s thoughtful solution to the difficult conundrum of products approved prior to adoption of the suffix policy. FDA will not change the nonproprietary names of already approved products in order to avoid confusion that could result. For these long-standing products, the brand name will be the distinguishing element and require more vigilance and effort by prescribers. This exception to the suffix protocol will ultimately play a role in the traceability of a limited number of biologics given that most products will not have biosimilars due to the challenges of biosimilar development.

ASBM Meets with Health Canada, FDA, WHO on Biologic Nomenclature Harmonization

March 7, 2019

On March 6th in Ottawa, Ontario, ASBM hosted the third in a series of meetings between health regulators and other stakeholders from around the globe to discuss the international harmonization of biologic nomenclature and the importance of distinguishable naming. Representatives from Health Canada, the FDA, and WHO participated.

The meeting began with opening remarks by ASBM Executive Director Michael Reilly thanking the participants. He emphasized the shared support for global harmonization and for WHO leadership in that effort. Participants then introduced themselves; they included:

Michael Reilly, Executive Director, ASBM
Philip Schneider, MS FASHP FFIP; Advisory Board Chair, ASBM
Madelaine Feldman, MD, FACR; Chair, ASBM
Rafaella Balocco Mattavelli, INN Programme Lead, World Health Organization
Anthony Ridgway, Health Canada
Stephanie Hardy, Health Canada
Andrew Spiegel, Global Colon Cancer Association
Gail Attara, Gastrointestinal Society
Ganive Bhinder, Better Pharmacare Coalition
Laurie Proulx, Canadian Arthritis Patient Alliance
Jaymee Maaghop, Canadian Cancer Survivor Network
Christine Janus, International Association of Dermatology Patient Organizations
Eric Lamoreaux, Canadian Patient Safety Institute
Maureen Smith, Canadian Organization for Rare Disorders
Angie Hamson, Patients for Patient Safety Canada
Karen J. Kieley, Royal College of Physicians and Surgeons
Caroline Herzberg, Canadian Dermatology Association

ASBM Advisory Board Chair Philip Schneider then presented a recap of the first two meetings, which were held in April and July of last year in Washington, DC. In these meetings, a strong consensus emerged on the importance of distinct naming and in favor of international harmonization. Health Canada in particular was a leading advocate of both.

Schneider then recounted several developments in the naming discussion that have occurred since the July meeting. First was the publication of the Scientific American whitepaper based on the April meeting, which may be read here. Second was ASBM’s participation in the 67th INN Consultation on October 13, 2018. Third was the publication of an article in the GaBI Journal emphasizing the benefits of the WHO’s Biological Qualifier (BQ) proposal for countries in the Middle East and North Africa region without robust pharmacovigilance systems of their own. The BQ would assign a 4-letter suffix to all biologics and biosimilars sharing an INN.

Dr. Schneider also shared objections to distinct naming- in particular to the WHO’s BQ proposal- that have been raised over the years, including that the system would be redundant, or might impede access, and proceeded to address them. For example, while advanced countries in Europe have robust pharmacovigilance systems, many developing nations do not. The Ministry of Health in the United Arab Emirates, Schneider noted, has expressed its support for the WHO’s BQ proposal, as have physicians in Latin America, 94% of whom consider it helpful in ensuring their patients receive the correct medicine.

Finally, Dr. Schneider discussed the surprising announcement by Health Canada on February 14th regarding their biologic naming policy. Despite their previous support for distinct naming and harmonization, their policy will in fact use shared nonproprietary names for multiple products, in conjunction with the brand name, and will rely heavily on the use of the Drug Identification Number (DIN). The DIN is used chiefly by Canadian pharmacists to track safety and efficacy issues. This policy is based on the results of a consultation in which a disproportionate number (62%) of the respondents were pharmacists and pharmacy organizations.

Pie chart of submissions by stakeholder group. Text equivalent follows.

As Dr. Schneider observed, this consultation and the resulting policy fails to adequately consider not only the perspectives of patients, but that of physicians.

physsupport For example, in a 2017 survey of 403 Canadian prescribers of biologics, ASBM found:

68% of physicians supported Health Canada assigning unique, distinct names to all biologics and biosimilars.
Only 1% of these physicians said they identify the medicine in the patient record using the DIN.
20% record only the product’s non-proprietary name in the patient record, not the brand name. This can result in inadvertent or inappropriate substitutions, as well as the physician not being aware of which among a number of products the patient will be dispensed at the pharmacy.
When reporting adverse events, only 4% of physicians use the DIN.
When reporting adverse events, 26% record only the product’s non-proprietary name. This can result in misattribution of an adverse event to the wrong product.
Only 23% of physicians consistently record batch/lot number when reporting adverse events.

Given physician support for distinct naming and their documented prescribing practices, ASBM’s analysis concluded that Health Canada’s announced policy does not adequately address the pharmacovigilance challenges of biologics and biosimilar medicines.

One of the reasons cited by Health Canada for the decision was lack of implementation by the WHO of an international naming standard, such as the BQ proposal. The FDA implemented a similar system in 2015 and had been in talks with Canada to harmonize nomenclature.

FDA official Lubna Merchant, who attended the first two meetings, joined the meeting via teleconference.

Ms. Merchant expressed regret that FDA and Health Canada were unable to come to an agreement to harmonize their nomenclature; and emphasized FDA’s continuing commitment to distinct naming as a tool to ensure accurate tracking of biologic medicines and their effects.

In response to Health Canada’s announcement, Patient advocate Angie Hamson of Patients for Patient Safety Canada highlighted her concern that minor differences between biologic medicines from different manufacturers could produce different effects, and that the use of shared nonproprietary names could make product identification harder for patients.

Despite Health Canada’s decision not to harmonize with the FDA suffix system, the regulator expressed its continued support for WHO leadership on establishing a global nomenclature standard, and the potential of harmonizing with such a standard if and when it is implemented.

Dr. Rafaella Balocco, WHO INN Programme lead, provided an update on the discussion of the international harmonization discussion from the WHO perspective, and assured the participants that she would convey the proceedings back to the WHO upon her return to Geneva.

Dr. Balocco also expressed hope that Canada’s decision would further underscore the urgent need for the WHO to take a leadership role on biologic naming and implement the BQ standard.

balocco-patient

Mr. Reilly closed the meeting by acknowledging that despite Health Canada’s decision not to pursue a suffix-based system, there still remains a common desire for international harmonization among many regulators worldwide, including Health Canada and FDA; and all parties agreed to continue work toward that goal by offering support to the WHO’s efforts.

View ASBM’s presentation here.

ASBM Chair Discusses Interchangeability, Need for Education

March 2, 2019

On January 7th, ASBM Chair Madelaine Feldman, MD FACR was interviewed by the Center for Biosimilars at a forum comprised pharmacists, clinicians, and representatives from biosimilar development companies. The topic was education on biosimilars. Dr Gillian Woollett of Avalere Health moderated the discussion, which was recorded at the group’s studio in New Jersey.
Clips from the interview may be viewed here throughout the month of March.

Below is the first clip, in which Dr. Feldman discusses the concept of interchangeability, post-market challenges to biosimilar uptake, the importance of physician education on biosimilars.

ASBM Chair Discusses Interchangeability, Need for Education

March 2, 2019

On January 7th, ASBM Chair Madelaine Feldman, MD FACR was interviewed by the Center for Biosimilars at a forum comprised pharmacists, clinicians, and representatives from biosimilar development companies. The topic was education on biosimilars. Dr Gillian Woollett of Avalere Health moderated the discussion, which was recorded at the group’s studio in New Jersey.
Clips from the interview may be viewed here throughout the month of March.

Below is the first clip, in which Dr. Feldman discusses the concept of interchangeability, post-market challenges to biosimilar uptake, the importance of physician education on biosimilars.