Safe Biologics

Inside Health Policy: “Safety, Generic Concerns Factors in Proposed AMA Biosimilar Resolution”

A perceived lack of safety information about biosimilars and past problems with substitution of generic drugs led neurologists and rheumatologists to ask the American Medical Association to study the safety of follow-on biologics. AMA is expected to considerer the topic further at a medical group meeting next week.

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European Medicines Agency Recommends Approval of First Two Monoclonal Antibody Biosimilars

The European Medicines Agency is reporting that its Committee for Medicinal Products for Human Use has recommended granting of marketing authorisations for Remsima and Inflectra, both containing the same known active substance, Infliximab. These two new biologics are recommended for the same indications as Remicade, covering a range of autoimmune diseases such as rheumatoid arthritis and Chron’s disease amongst others.

Read more here.

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Dolinar Adds to the Emerging Consensus Among Stakeholders on the Need for Unique Names

Last week in Ottawa, Alliance for Safe Biologic Medicines (ASBM) chairman, Richard Dolinar M.D., was one of a small group of patient advocates invited to address international regulators at the “Regulator Forum on Biologic Naming and Traceability” hosted by Health Canada and BIOTECanada. Dolinar’s presentation added a physician’s perspective to the emerging consensus that unique distinguishable INN names play a central role in pharmacovigilance and traceability systems that enable clearer communication with patients, medical staff and pharmacists.

“Biologics are highly sensitive to the manufacturing process and their environment; slight differences can have unexpected results,” stated Dr. Dolinar at the event. “As a physician, patient safety is paramount. I need to know as quickly as possible when and which product is associated with an unexpected outcome in order to treat my patients effectively. Identical names imply identical products, which will not be the case when biologics are made using different manufacturing processes and/or cell lines. If distinct non-proprietary names are not given to products, we may waste valuable treatment time trying to identify the root cause, and the patient will suffer.”

Read more here.

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ASBM Video Feature for Canada’s Globe and Mail

Executive Director Michael Reilly participated in a taping for Globe and Mail, Canada’s national newspaper which has been in print for 167 years. Reilly joined Karen Burke of Amgen, and Jackie Manthorne from the Canadian Cancer Survivors Network in a video series of vignettes that will introduce the Globe and Mail audience to the emerging issue of biosimilars. In his piece, Reilly focused on the unique process in creating biosimilars, as well as spoke to the regulatory policies in development in Canada, the EU and the US.

These compelling videos, which are expected to be released in the next month or so, are easy briefings and sharable via social media.

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EuropaBio joins the Alliance for Safe Biologic Medicines

The Alliance for Safe Biologic Medicines is pleased to announce the addition of EuropaBio to its membership.

EuropaBio is the European Association for Bioindustries, bringing together bioscience companies from all fields of research and development, testing, manufacturing and distribution of biotechnology products. It has 56 corporate members, 14 associate members and Bio Regions and 19 National Biotechnology Associations – representing some 1800 small and medium sized enterprises across Europe.

“With the partnership of EuropaBio, the Alliance for Safe Biologic Medicines can continue to ensure the affordability and accessibility of biologic medications while never compromising on patient safety, here in the US and across the globe.” stated Dr. Richard Dolinar, Chairman of the ASBM. “We are pleased to have such an authoritative international partner who will add their voice to important policy decisions surrounding safety and efficacy for patients as more biologics become available.”

“EuropaBio member companies are highly committed to deliver safe biologic medicines to the patient. We work together with biologic and biosimilar manufacturers, health care professionals, patient groups and other key stakeholders to ensure patient safety is at the forefront of the biosimilars policy discussion,” commented EuropaBio Biosimilar topic group leader Stefan Bergunde.

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White Paper Compares US and EU Regimes

A white paper entitled, “A Comparison of US and EU Regimes,” authored by Michael J. Shuster, Ph.D., Partner of the Intellectual Property Group and Co-Chair of the Life Science Group and Associate Pauline Farmer-Koppenol, MS of the Intellectual Property Group, was recently released by Fenwick & West, LLP. The article presents an overview of their biosimilars regulations, in order to help legal and executive decision makers at biopharmaceutical companies begin to think about the range of expenditures that may be necessary for approval of a biosimilar.

View full white paper here.

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ASBM Participates in BioWorld Webinar

Executive Director of ASBM, Michael Reilly recently moderated “The Promise of Biosimilars for the Biotech Industry: Opportunities and Challenges of this Emerging Market,” an educational webinar hosted by BioWorld Today. Presenters included, Sheila D. Walcoff, JD, a health-policy expert formally with HHS and the founding principal of Goldbug Strategies LLC; and Dirk Reitsma, MD, Vice President and Head of Oncology Global Product Development at PPD, who has extensive clinical development experience.

The webinar consisted of a 60-minute presentation focused on the emerging US policy on biosimilars as well as the scientific factor in determining interchangeability, followed by a question and answer session.

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Dolinar Addresses DIA: Quality, Manufacturing Transparency Key to Avoiding Drug Shortages

Speaking at the 49th Annual Drug Information Association (DIA) Conference in Boston, Dr. Richard Dolinar, presented an analysis of past drug shortages and discussed how policies toward biologic drugs can be developed to guard against short supply. Dolinar’s presentation, entitled “Characterizing Drug Shortages and Their Causes: Anticipated Future Trends,” stresses that quality and consistency are vital for ensuring a steady and safe supply of biologic medicines for patients.

“It is important for prescribers to understand how policies toward biologic drugs are taking shape and why manufacturing quality remains key to supply,” said Dr. Dolinar, a practicing endocrinologist. “Biologics are incredibly complex and as such not yet well understood, but we can avoid the pitfalls of the past by developing sound policy that centers on patient safety and efficacy.”

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International Leaders Added to ASBM Advisory Board

Professor Stavljenić-Rukavina, Vice Dean for Science at the Dubrovnki International University has officially joined ASBM as an International Advisory Board Member as a result of ASBM’s presence in Geneva. Professor Rukavina has spent many years as a professor at the University of Zagreb School of Medicine, and is a founder of the Croatian Association for Quality in Health Care. She has had a varied career as a politician (served as Minister of Health), academic and consultant.

ASBM is also pleased to add Dr. Victoria Pinkney-Atkinson, Executive Director of the Patient Health Alliance of Nongovernmental Organisations (PHANGO) in South Africa and Virginia Ladd, President of the American Autoimmune Related Diseases Association.

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State Legislation Update

ASBM has remained diligent in supporting patient-focused legislation on biosimilar substitution, particularly in California and Delaware.

In California, SB 598 has been under consideration in the State Assembly where it was double referred to the Assembly Business, Professions and Consumer Protections Committee and the Assembly Health Committee. SB 598 passed both committees and is now expected to go to the Appropriations Committee for a pro forma vote, since it should have no fiscal impact.

ASBM and its individual partners have also submitted letters in support of SB 118 under consideration in Delaware. The legislation was reported out of the Senate Sunset Committee on June 18th with a favorable vote. Currently, SB 118 is in a holding pattern and is expected to be at the top of the agenda starting in 2014.

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State Legislation Update

Several state legislatures have have adjourned for the year, but we continue to urge support for California Senate Bill 598, which passed off the Senate Floor (29-4) on Friday, May 24. The bill now heads to the State Assembly where it is expected to be double-referred to the Assembly Business, Professions and Consumer Protections Committee and the Assembly Health Committee.

The earliest SB 598 could be heard is Tuesday, June 11.

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Dr. Bruce Rubin Op-Ed featured in the Florida Herald Tribune

An Op-Ed by Dr. Bruce Rubin recently ran in the Herald Tribune titled “Medicine safeguard missed.”

In the piece he says:

“In my care of patients, I see pharmacist notification to a physician if he or she has substituted a biologic product for its interchangeable biosimilar as absolutely critical to provide proper management and care of my patients. If a patient has an adverse reaction to a medicine, I would need to be able to identify the drug that the patient is receiving to effectively care for my patient.

“I see great value in the introduction of more affordable biosimilar medicines, which will increase access for millions of Americans to a life-improving opportunity. Biologics have helped the field of neurology to treat some of our toughest cases. However, I believe that the doctor must remain at the center of the prescribing process in order to protect the safety of patients.”

Read the full piece here.

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Patient Calls for Notification in the Baltimore Sun

The Baltimore Sun had an Op-Ed by a Rockville patient on the biosimilar substitution debate in Maryland and the critical need for notification.

In “Debate over ‘biosimilars,’ patient safety must come first” the author wrote:

“I’m grateful for biosimilars, as I welcome anything that can lower the costs of my medicine. But I believe a few common-sense safety measures need to be put in place to protect patient health when substitutions are made.

“First, pharmacists should only be allowed to substitute a biosimilar if it has been approved by the Food and Drug Administration as interchangeable with the original biologic medicine. This means it has undergone rigorous testing, and it has been shown to be close enough to the original product that the benefits outweigh the risks.

“Second, doctors must have the right to tell pharmacists that a prescribed biologic shouldn’t be substituted with a biosimilar, because the biologics might be necessary for a patient with allergies or multiple conditions like me. This is the same process that’s in place for generic drugs. It doesn’t make sense to be any less cautious with a drug that’s much more complex.

“Third, and most important to me, pharmacies should be required to notify patients and their doctors when a biosimilar substitution is made. This simple step, along with the FDA’s determination that the drug is interchangeable, would give me 100 percent confidence in what I’m about to put into my body. If my doctor and I don’t know I received a different drug, how can we both know to be mindful of any new reactions or changes?”

Read the piece here.

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EuropaBio, Global Colon Cancer Alliance and ZERO Join ASBM

We are very excited to announce three new members are joining ASBM. On the international front, EuropaBio and the Global Colon Cancer Alliance are now members. ZERO – The Project to End Prostate Cancer, the largest prostate cancer patient group will also be joining. We look forward to the valuable experience they each bring in regards to biosimilar policy focused on patient safety.

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New Advisory Board Members Join ASBM

In addition to adding new organizations to our membership, we have also had several new International Advisory Board Members join ASBM.

Dr. Frank Lavernia has been a practicing diabetologist in South Florida for over 30 years and is the founder and director of the North Broward Diabetes Center in Pompano Beach, Florida.

Dr. Marc J. Inglese is an Assistant Clinical Professor in the Division of Dermatology at the Florida State University College of Medicine and a partner at Dermatology Associates of Tallahassee.

Spencer Lieb is an HIV/AIDS Research Coordinator, Epidemiologist with the AIDS institute who is also an AIDS patient.

Stephen Murby is a board director of Consumers Health Forum of Australia, a member of the Stakeholder Advisory Committee of the Australian Independent Hospital Pricing Authority and a member of IAPO’s 6th Global Patents Congress Advisory Committee and a Life Fellow of the Royal Society of Arts.

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Video Interviews with ASBM Executive Director Michael Reilly

Executive Director Michael Reilly spoke with Bloomberg BNA on the challenges facing the biosimilars process both in the U.S. and abroad. He also did a video interview with John Lewis and the Association of Clinical Research Organizations.

Watch the BNA Video Insights interview here.

Watch the ACRO HealthChannel video here.

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DIA Conference in Boston

On June 24, Dr. Dolinar will be participating on the Characterizing Drug Shortages and Their Causes: Anticipating Future Trends panel at the DIA 2013 49th Annual Meeting program at the Boston Convention and Exhibition Center.

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Ottawa Forum on Naming

Dr. Dolinar will be participating in the Regulatory Forum on Biologic Product Naming and Traceability in Ottawa on June 26 to discuss the various regional approaches to biologic naming and the potential implications of the current INN (International Non-Proprietary Name) system.

State Legislation Update

Several state legislatures have have adjourned for the year, but we continue to urge support for California Senate Bill 598, which passed off the Senate Floor (29-4) on Friday, May 24. The bill now heads to the State Assembly where it is expected to be double-referred to the Assembly Business, Professions and Consumer Protections Committee and the Assembly Health Committee.

The earliest SB 598 could be heard is Tuesday, June 11.

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Dr. Bruce Rubin Op-Ed featured in the Florida Herald Tribune

An Op-Ed by Dr. Bruce Rubin recently ran in the Herald Tribune titled “Medicine safeguard missed.”

In the piece he says:

“In my care of patients, I see pharmacist notification to a physician if he or she has substituted a biologic product for its interchangeable biosimilar as absolutely critical to provide proper management and care of my patients. If a patient has an adverse reaction to a medicine, I would need to be able to identify the drug that the patient is receiving to effectively care for my patient.

“I see great value in the introduction of more affordable biosimilar medicines, which will increase access for millions of Americans to a life-improving opportunity. Biologics have helped the field of neurology to treat some of our toughest cases. However, I believe that the doctor must remain at the center of the prescribing process in order to protect the safety of patients.”

Read the full piece here.

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Patient Calls for Notification in the Baltimore Sun

The Baltimore Sun had an Op-Ed by a Rockville patient on the biosimilar substitution debate in Maryland and the critical need for notification.

In “Debate over ‘biosimilars,’ patient safety must come first” the author wrote:

“I’m grateful for biosimilars, as I welcome anything that can lower the costs of my medicine. But I believe a few common-sense safety measures need to be put in place to protect patient health when substitutions are made.

“First, pharmacists should only be allowed to substitute a biosimilar if it has been approved by the Food and Drug Administration as interchangeable with the original biologic medicine. This means it has undergone rigorous testing, and it has been shown to be close enough to the original product that the benefits outweigh the risks.

“Second, doctors must have the right to tell pharmacists that a prescribed biologic shouldn’t be substituted with a biosimilar, because the biologics might be necessary for a patient with allergies or multiple conditions like me. This is the same process that’s in place for generic drugs. It doesn’t make sense to be any less cautious with a drug that’s much more complex.

“Third, and most important to me, pharmacies should be required to notify patients and their doctors when a biosimilar substitution is made. This simple step, along with the FDA’s determination that the drug is interchangeable, would give me 100 percent confidence in what I’m about to put into my body. If my doctor and I don’t know I received a different drug, how can we both know to be mindful of any new reactions or changes?”

Read the piece here.

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EuropaBio, Global Colon Cancer Alliance and ZERO Join ASBM

We are very excited to announce three new members are joining ASBM. On the international front, EuropaBio and the Global Colon Cancer Alliance are now members. ZERO – The Project to End Prostate Cancer, the largest prostate cancer patient group will also be joining. We look forward to the valuable experience they each bring in regards to biosimilar policy focused on patient safety.

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New Advisory Board Members Join ASBM

In addition to adding new organizations to our membership, we have also had several new International Advisory Board Members join ASBM.

Dr. Frank Lavernia has been a practicing diabetologist in South Florida for over 30 years and is the founder and director of the North Broward Diabetes Center in Pompano Beach, Florida.

Dr. Marc J. Inglese is an Assistant Clinical Professor in the Division of Dermatology at the Florida State University College of Medicine and a partner at Dermatology Associates of Tallahassee.

Spencer Lieb is an HIV/AIDS Research Coordinator, Epidemiologist with the AIDS institute who is also an AIDS patient.

Stephen Murby is a board director of Consumers Health Forum of Australia, a member of the Stakeholder Advisory Committee of the Australian Independent Hospital Pricing Authority and a member of IAPO’s 6th Global Patents Congress Advisory Committee and a Life Fellow of the Royal Society of Arts.

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Video Interviews with ASBM Executive Director Michael Reilly

Executive Director Michael Reilly spoke with Bloomberg BNA on the challenges facing the biosimilars process both in the U.S. and abroad. He also did a video interview with John Lewis and the Association of Clinical Research Organizations.

Watch the BNA Video Insights interview here.

Watch the ACRO HealthChannel video here.

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DIA Conference in Boston

On June 24, Dr. Dolinar will be participating on the Characterizing Drug Shortages and Their Causes: Anticipating Future Trends panel at the DIA 2013 49th Annual Meeting program at the Boston Convention and Exhibition Center.

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Ottawa Forum on Naming

Dr. Dolinar will be participating in the Regulatory Forum on Biologic Product Naming and Traceability in Ottawa on June 26 to discuss the various regional approaches to biologic naming and the potential implications of the current INN (International Non-Proprietary Name) system.

State Legislation Update

ASBM member organizations and our Advisory Board members have been actively supporting patient-focused legislation on biosimilar substitution by sending letters and testifying at hearings, particularly in California, Colorado, Florida, Indiana and Maryland.

In California, SB 598, which we support, passed out of the Senate Business, Professions and Economic Development Committee hearing on April 8 and will be heard in the Senate Health Committee on May 1. We are also monitoring Assembly Bill 1139, which we oppose, that has been assigned to the Assembly Business, Professions and Consumer Protection and will be heard on April 30, 2013.

Colorado HB 1121 passed the House on February 2 and there is a Senate Health and Human Services Committee hearing scheduled for Thursday, May 2. We are hopeful that he Senate takes up the bill before the session adjourns on May 8.

In Florida, we supported SB 732, until the physician notification component was removed by amendment and as a result we now oppose the bill. The Senate is scheduled to take up the measure before adjourning Sine Die on May 3. ASBM Advisory Board Member, Dr. Frank Lavernia, testified in Tallahassee on April 2 and explained the importance of notification. Watch the video here, his testimony begins at the 58 minute mark.

HB 1315 in Indiana was sent to a conference committee, but all references to biosimilars were stripped out of the bill before the session adjourned on April 26.

Joseph Jefferson and Allen Todd both spoke at the House Health and Government Operations Committee hearing in Maryland on April 4, unfortunately the legislative session ended on April 8, before the bill was voted on. Read HealthHIV’s testimony and Global Healthy Living Foundation’s testimony.

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Dr. Bruce Rubin Op-Ed featured in South Florida Sun Sentinel

An Op-Ed by Dr. Bruce Rubin recently ran in the Sun Sentinel. From Keep Doctors Informed and Patients Safe:

“To ensure safety of the patients taking biologic medicines, I lend my support, as a neurologist, to legislation working its way through the Florida Legislature, which will safely allow for the substitution of a new category of imitative biologic medicines, known as biosimilars…

“Physician notification is necessary to the success of my practice. Because of the unique characteristics of biologics and biosimilars, it is extremely important for me to know if a change had been made in my prescription. If a patient has an adverse reaction to a medicine, I would need to be able to identify the specific product that the patient received.

“These bills provide the necessary safeguards to make biosimilars accessible for the residents of Florida and give specialists like myself the assurances they need to prescribe biologics at pharmacy counters.”

Read the full piece here.

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Physician LTE in The Gainesville Sun

A letter to the editor by Dr. Marc Inglese in The Gainesville Sun urges Florida lawmakers to focus biosimilar policy on patients, rather than on cost. In his letter, Don’t Sacrifice Safety, he said the following:

“I am in the practice of medicine to help my patients receive the best possible care. I am excited that biosimilars will soon be available to my patients at a lower cost, however, I do not want the possibility that their safety could be sacrificed in the process. Even the smallest difference in the structure of a biologic medicine and its attempted copy can have a significant impact on a patient, which is why physicians must be notified when one complex biotech drug is substituted for another. I cannot properly care for my patients if I do not know what medicine they are taking.”

Read the full piece here.

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Making the Case for Physician Notification

Dr. Jerry Felando, a cancer survivor, retired medical professional and former member of the California State Legislature wrote an Op-Ed for Capitol Weekly in Sacramento explaining why legislation must include notification.

From In Search of Affordable Health Care:

“The merits of notification relating to patient care should be obvious. Physicians have to know what medicines their patients are taking. If a pharmacist substitutes one complex drug for another, the physician should be made aware – it is in the best interest of the patient. This is even more true in the case of biologics and biosimilars that are treating debilitating diseases where there is no room to recover lost ground.

“Leaving patients and physicians in the dark as to when a substitution occurs is spinning the health care roulette wheel. Have we sunk to the point in our country where we are ready to put a patient in jeopardy because a pharmacist and physician are not communicating? I certainly hope not.”

Read more here.

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Correcting the Indianapolis Business Journal

An Indianapolis doctor responded to a recent article in the Indianapolis Business Journal stressing the need to put patients at the center of the biosimilar substitution debate.

In Biologics Misunderstood, Dr. David Blank wrote:

“The author refers to attempted copies of biotech medicines as ‘generic biotech medicines.’ This demonstrates a fundamental misunderstanding of biosimilars.

“Biologics are complex molecules that cannot be copied, whereas generics are exact copies of chemical drugs. Failure to understand this distinction results in a failure to understand why patient safety concerns are legitimate not only by drug companies, but by physicians who prescribe them.

“As someone who treats patients whose health depends on access to biologics, it is troubling to me that the notion of alerting a patient that the medicine their physician prescribed them is being switched is onerous. There may be good reasons not to make a substitution, that a pharmacist may be unaware of, and it should be the physician’s role to help their patient make that decision.”

Read more here.

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Crain’s Chicago Business Op-Ed

Crain’s Chicago Business ran an Op-Ed by David Miller, president and CEO of the Illinois Biotechnology Industry Organization, on the need for the Illinois General Assembly to ensure patient safety when it comes to substitution.

In his Op-Ed, State Can Clear Path for Biosimilar Drugs, he wrote:

“Surprisingly, large chain drugstores and pharmacists oppose the bill because they claim that notifying a doctor is too big a burden and restrictive. This is disappointing. If I am late picking up a prescription, I get robo-calls from my drugstore. I receive texts and calls telling me it is time to renew a prescription, and my pharmacist will hunt down my internist to get a prescription renewed or suggest a different drug for me. If these stores have time to do all these things, why is it a burden to inform my doctor what medication I am taking to ensure I get the best possible care?

“This legislation promotes, not restricts, biosimilars in Illinois, and I have a strong interest in this bill because I’m a patient who has benefited from biologics.”

Read the full article here.

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ASBM Quoted in FDA News

Executive Director Michael Reilly was recently quoted in an FDA News article on new draft guidances on biosimilars.

From FDA Draft Guidance Sets Rules for Biosimilar Meetings:

“The FDA recently tiptoed into largely uncharted waters, issuing draft guidance laying out the ground rules for formal meetings between review staff and makers of biosimilars.

“The document, which provides particulars on scheduling, preparing and conducting a formal meeting, appears to be an effort to ‘get the ball rolling’ on a new process that many drugmakers are still struggling to comprehend, said Michael Reilly, executive director of the Alliance for Safe Biologic Medicines.

“‘I think that the applications aren’t rolling in yet because people are still trying to figure out what an application process is going to look like,’ Reilly said. ‘Are you doing a BLA or a biosimilar application? That is a decision that manufacturers and investors have to make.'”

Read the full article here.

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FDLI Conference with CBER

On April 23, Michael Reilly participated in the Food and Drug Law Institute (FDLI) 2013 Annual Conference, speaking on a panel on the priorities and challenges facing the FDA and the Center for Biologics Evaluation and Research (CBER).

Read more here.

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IAPO Conference in Geneva

On May 2-3 Michael Reilly and Andrew Spiegel will be participating in the International Alliance of Patients’ Organizations (IAPO) Workshop on Biosimilar Medicines in Geneva, Switzerland.

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DIA Meeting in Boston

Mark your calendars: ASBM will be presenting at the DIA 2013 49th Annual Meeting June 23-27 in Boston and will be participating on a panel on “Pharmacovigilance in the Age of Biosimilars” on June 24.

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