Posts – Page 50 – Safe Biologics

ASBM Presents at 61st WHO Naming Consultation

October 13, 2015

Geneva, Switzerland – On October 13^th, the Alliance for Safe Biologic Medicines (ASBM) presented before the World Health Organization’s (WHO’s) 61^st Consultation on International Nonproprietary Names (INN). ASBM Chairman Harry L Gewanter, MD presented physician perspectives on biosimilar naming gathered from prescribers in eleven countries. This included data from ASBM’s recent survey of Latin American physicians, 94% of whom supported the WHO’s Biological Qualifier (BQ) Proposal, which would assign a unique four-letter suffix to each biologic. A similar and potentially-compatible naming system was proposed by the U.S. Food and Drug Administration (FDA) in Draft Guidance released September 28^th.

“Clear product identification is critical to physicians around the world, and it aids regulators in tracking the long-term safety and efficacy of these medicines. We are encouraged by the positive reception the BQ is receiving both from physicians and from other leading regulators like the FDA, and are honored to participate in its development”, said Gewanter.

Joining him to present the pharmacist perspective on biologic naming was Ronald P. Jordan, Dean of the Chapman University School of Pharmacy, former president of the American Pharmacists Association and current ASBM Advisory Board member.

Jordan shared data from ASBM’s survey of 401 U.S. pharmacists, which found 68% supported distinguishable naming for all biologics, including biosimilars.

“These results are not surprising;” said Jordan. “Pharmacists know that their ability to improve patient outcomes and safety is hampered, unless they can clearly distinguish similar biologic medicines from one another. Distinguishable names are essential for tracking, reporting and discussion of specific product indications, contraindications or any potential adverse responses. To protect the hope these new agents offer in terms of better care and lower costs, clearly associating use and results accurately with each source, requires precise product identification.”

ASBM has been very supportive of the WHO’s draft BQ proposal, providing data and testimony in the last several INN Open Sessions for Stakeholders, most recently the 60^th Consultation held in April, and the INN’s Front Page Meeting held in June.

Michigan House To Take Up Biosimilars Bill

October 9, 2015

The Committee on Health Policy is shortly expected to begin hearings on House Bill 4812. HB 4812 was introduced by Rep. John Bizon, a physician, and contains many valuable protections such as patient notification, pharmacist-physician communication within 5 days of a substitution, and DAW (dispense as written) authority for the prescribing physician. The bill has garnered bipartisan support and has more than 20 cosponsors, including several representatives who are physicians. ASBM sent a letter of support for HB 4812 to Committee Chair Mike Callton and all Committee Members. A competing bill, HB 4437, introduced by Rep. Ken Yonker, contains some but not all of these elements, and while well-intentioned, it is ASBM’s position that this bill does not adequately address the safety and communication challenges of biosimilar substitution.

CA Governor Brown Signs Biosimilars Bill

October 6, 2015

On October 6, California Governor Edmund “Jerry” Brown signed into law SB 671, which permits pharmacists to substitute an interchangeable biosimilar in place of its reference product, provided the pharmacist communicates the substitution to the physician within five days time so that an accurate patient record is maintained, and the physician has not indicated “do not substitute” on the prescription. In a letter dated September 3rd,, ASBM urged Governor Brown, who had previously vetoed a similar bill, to support SB 671.

ASBM Presents to New York State Rheumatology Society

October 2, 2015

At the New York State Rheumatology Society 2015 Fall Meeting, held October 2nd in Saratoga, NY, ASBM presented a briefing entitled “Biosimilars: Regulatory Challenges and Physician Perspectives”. which discussed the current state of U.S. and international biosimilar regulation, including the topics of biosimilar naming, labeling, and substitution. ASBM shared survey data from physicans in eleven countries on these issues. Mr. Reilly also expressed his confidence the FDA will soon issue its long-awaited guidance on interchangeability, which would define the criteria a biosimilar must meet in order to be safely substituted for its reference product.

Mr. Reilly’s presentation may be viewed here.

All ASBM prescriber surveys may be viewed at www.safebiologics.org.

ASBM Presents to New York State Rheumatology Society

October 2, 2015

Mr. Reilly’s presentation may be viewed here.

All ASBM prescriber surveys may be viewed at www.safebiologics.org.

ASBM Statement on FDA Draft Guidance: “Nonproprietary Naming of Biological Products”

September 1, 2015

The Alliance for Safe Biologic Medicines commends the FDA for its leadership on biosimilars by releasing guidance that recognizes the need for all biologic medicines, including biosimilars, to be clearly distinguishable from one another. This clarity will aid in accurate product identification during prescribing, dispensing, and pharmacovigilance. Distinguishable naming is particularly important with the arrival of biosimilars, so that any unexpected effects or adverse events can be attributed to the correct product and that non-interchangeable biosimilars are not inadvertently and/or inappropriately substituted.

It has long been ASBM’s view that distinguishable naming will allow physicians to maintain an accurate patient record, help pharmacists promote patient safety, improve adverse event reporting, and promote manufacturer accountability. Further, the four-letter differentiating suffix proposed by the FDA is potentially compatible with the four-letter Biological Qualifier (BQ) suffix proposed by the World Health Organization (WHO), which if adopted would extend the protections of distinguishable naming to patients throughout the world, regardless of in which country they receive treatment.

While the FDA’s proposed four-letter suffix will prevent unnecessary and potentially harmful ambiguities, there still remains room for improvement. In particular, the differentiating suffix deliberately designed to be “devoid of meaning” creates an unnecessary barrier to the use of distinguishable suffixes. It is ASBM’s position that a uniform and meaningful, intuitive suffix applied consistently to all products by a single manufacturer would be more memorable and thus easier for healthcare providers to use, limit proliferation of suffixes, and reduce the likelihood of juxtaposition or confusion. The four-digit code used in FDA’s approval of the first biosimilar, Zarxio (filgrastim-sndz), for example, is clearly based on the name of the biosimilar’s sponsor, Sandoz. Unlike the proposed random and meaningless suffix, “-sndz” is not only memorable and logical, but it promotes manufacturer accountability.

ASBM welcomes the chance to submit further comments on the draft guidance and once again thanks the FDA for their leadership in releasing biosimilar guidance that reflects its longstanding commitment to patient safety and transparency.

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ASBM Conducts CE Course for Oregon Health System

August 1, 2015

On July 31, in Bend, Oregon, ASBM conducted a continuing education (CE) course for physicians, pharmacists, nurses, and other healthcare providers at six hospitals in the St. Charles Health System. Headquartered in Bend, Oregon, the system owns and operates St. Charles Madras, St. Charles Redmond, Pioneer Memorial Hospital, Blue Mountain Hospital, Lake District Hospital, and Harney District Hospital. The health system employs more than 3,000 people.

The course, entitled “Biosimilars: What Every Physician and Pharmacist Needs to Know” was presented by ASBM Executive Director Michael Reilly, and covered the definition of biologics and biosimilars, the difference between biosimilars and generic chemical drugs for purposes of patient care, associated regulatory challenges, and the importance of physician-pharmacist communication and cooperation.

“Biologic medicines are among the most powerful therapeutic tools healthcare providers have at their disposal to treat patients with serious conditions like rheumatoid arthritis and colorectal cancer,” said Reilly. “Biosimilars will soon provide them with new therapeutic options, potentially at reduced cost to their patients- but they also bring new challenges… learning about them is critical to providing quality care.”

Mr. Reilly’s presentation may be viewed here.

The 1-hour CE course was accredited by the Oregon Medical Association, the American Academy of Family Physicians, the Oregon Board of Pharmacy, and the California Board of Registered Nursing.

ASBM writes FDA on Need for Distinguishable Naming

July 20, 2015

In a letter dated July 20, 2015, ASBM Chairman Harry Gewanter, MD wrote FDA Acting Commissioner Stephen Ostroff MD on the need for all biologic medicines, including biosimilars, to be named so as to be easily distinguishable from one another. The FDA is expected to release its long-awaited guidance on biosimilar naming later this year.

In the letter, Dr. Gewanter praised the FDA’s recent use of a distinguishing suffix in its March approval of the first U.S. biosimilar, Zarxio (filgratim-sndz) calling it a “simple and eloquent solution” for identifying both the product and the legal entity responsible for its safety and efficacy (“-sndz” being based on the name of the product’s manufacturer, Sandoz).

Dr. Gewanter stressed than ASBM’s surveys of nearly 1700 prescribers of biologics found both a critical need and strong physician support for distinguishable naming:

17% of physicians in the U.S. and Canada, 24% of those in Europe, and 57% in Latin America used the INN exclusively when identifying the medicine in the patient record, thus creating the potential for the patient to receive the wrong medicine, and the patient record to be made inaccurate by any substitution.
When reporting adverse events, 26% of Canadian, 17% of European, and 28% of Latin American physicians refer to the medicine exclusively by its INN – thereby potentially resulting in attributing these effects to the wrong medicine, pooling of adverse events, and other difficulties.

Physician prescribing practices further showed that other attempts to ensure clear product identification, such as batch numbers and NDC codes, were shown by physician prescribing to be an inadequate solution:

ASBM examined the viability of NDC as a potential means of identification, but found only 0.3% of U.S. physicians used NDCs when identifying medicines in a patient record, and 0.5% when reporting adverse events. We also looked at the use of batch/lot numbers in countries with biosimilars and found that only 40% of European, and 26% of Canadian physicians consistently used batch numbers when reporting adverse events. Further, 45% of European and 27% of Canadian physicians never used them at all.

By contrast, distinguishable naming of biosimilars was overwhelmingly supported by physicians in two recent ASBM surveys. A 2014 found 79% of Canadian physicians supported Health Canada issuing distinguishable names for biosimilars. Similarly, a May 2015 survey found 94% of Latin American physicians supporting the World Health Organization’s (WHO’s) proposal to differentiate similar biologics with a four-letter differentiating suffix called a “biological qualifier” (BQ).

ASBM had previously shared the data with Administration officials in a May 19 meeting with Administration officials which included representatives from the U.S. Office Management and Budget (OMB), the Office of Information and Regulatory Affairs (OIRA), the National Economic Council (NEC), and the Department of Health and Human Services (HHS).

All ASBM surveys are available at www.safebiologics.org.

Dr. Gewanter’s letter to Acting Commissioner Ostroff may be read here.

ASBM Welcomes Hepatitis Foundation International to Steering Committee

July 17, 2015

ASBM is pleased to announce the addition of Hepatitis Foundation International to its steering committee. The Foundation joins other patient and physician groups who help further the mission of organization which is to ensure the patient remains at the forefront of biologic and biosimilar policy making.

The Hepatitis Foundation International is a 501(c)3 non-profit organization established in 1994 working to eradicate chronic hepatitis for 400 million people globally. HFI is dedicated to increasing and promoting health and wellness; reducing the incidence of preventable liver-related chronic diseases, and lifestyles that negatively impact the liver. Some of these diseases include: obesity, diabetes, hepatitis, substance abuse, HIV/AIDS, cardiovascular disease and fatty/liver cancer. The HFI reaches well over 5 million patients and health care professionals annually through its public and private partnerships.

ASBM welcomes the international voice for the Hepatitis community to its steering committee to ensure the voice of the hundreds of millions affected by the disease are heard.

ASBM, Patient Groups Write Australia on Proposed Substitution Policy

July 6, 2015

On May 26, 2015 Australian Health Minister Sussan Ley announced that Australia would become the first nation in the world to allow so-called “automatic” substitution of biosimilars by pharmacists in place of the biologic prescribed by a physician. This move came at the recommendation of Australia’s Pharmacy Benefits Advisory Committee (PBAC).

In response to this development, ASBM and several member patient groups sent letters raising patient safety concerns to Minister Ley and other prominent officials in the Australian government, including members of the relevant Senate Committee in advance of its hearing on the matter.

Australia Breaks with Leading Regulators, Joining Venezuela in Permitting Pharmacy-level Substitution

The proposal would make Australia the only first-world country to allow pharmacy-level substitution of biosimilars. The practice is opposed by both the European Medicines Agency and Health Canada, the global leaders in in biosimilar approvals, both of which leave the determination of which biologic medicine a patient receives solely to their physician.

The practice is explicitly banned in many countries including the UK, Germany, Ireland, Spain, Sweden, Norway, and Finland. While France statutorily permits automatic substitution in certain limited cases, this policy has never been implemented.

The U.S. Food and Drug Administration, which approved its first biosimilar in March, has not yet determined what safety and efficacy data it would require from a biosimilar’s sponsor in order to demonstrate that it could be safely substituted for its reference product.

Only Venezuela currently permits the practice.

ASBM Surveys Find Global Physician Opposition to Automatic Substitution

ASBM’s letter to Minister Ley cites data from four surveys of biologic-prescribing specialists in 11 countries. These data show that most prescribers of biologics (62% of the European physicians, 71% of the Canadian physicians and 85% of Latin American physicians) consider a pharmacy-level determination of which biologic to dispense to their patient to be “unacceptable”.

Additionally, notification in the event of a biosimilar substitution was considered “very important” or “critical” by 80% of U.S., 77% of European, 85% of Canadian, and 87% of Latin American physicians surveyed.

The ability to prevent a substitution by indicating “do not substitute” or “dispense as written” on the prescription was considered “very important” or “critical” 82% of U.S., 74% of European, 80% of Canadian, and 85% of Latin American physicians surveyed.

All ASBM surveys are available at www.safebiologics.com.

This concern among physicians is also reflected in comments by Australian Rheumatology Association (ARA) President Dr Mona Marabani who warned of patient safety concerns:

The proposed new powers will allow pharmacists to switch particular drugs at the pharmacy counter with the potential for patients to get a different drug every time they go to the chemist…Advisory bodies within Australia (e.g. Council of Australian Therapeutic Advisory groups) and leading regulators around the world do not advise switching these drugs, as we do not know if it is safe.

Patient Advocates Share Safety Concerns

Australian patient advocate and ASBM Advisory Board member Stephen Murby wrote a letter to Minister Ley in which he said of the move:

Allowing automatic substitution of biosimilars is an enormously retrograde step for Australia. One which is completely out-of-kilter with world best practice and which has the potential to reduce the standards of safe use of biosimilars for patients.

Two ASBM Steering Committee members also sent letters to Minister Ley and the Australian Senate:

The Global Colon Cancer Alliance (GCCA), sent a letter opposing pharmacy-level substitution of biosimilars “until these medicines have been sufficiently evaluated for safety and efficacy, including repeated switching between products — whether it be between the reference biologic and a biosimilar or between two biosimilars.”

The International Cancer Advocacy Network (ICAN) also sent a letter to Minister Ley, in which ICAN President Marcia Horn highlighted ICAN’s safety concerns and suggested that contrary to expectations, substitution without physician involvement could actually increase costs:

For all patients who do not respond to the originally intended treatment, and especially those patients who suffer adverse reactions, [due to substitution without physician involvement] physicians would be in the dark as to the cause. This will require precious physician time, additional diagnostic tests, and in the cases of significant reactions, hospitalization.

ASBM will continue to monitor developments in Australia as they develop.