Dolinar Adds to the Emerging Consensus Among Stakeholders on the Need for Unique Names at an International Regulator Forum

July 1, 2013

Ottawa, ONTARIO – 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 on June 26 and 27. Dolinar’s presentation added a physician’s perspective to the emerging consensus that unique product names are key to patient safety.

“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.”

Dolinar’s presentation stressed that unique distinguishable INN names play a central role in pharmacovigilance and traceability systems that enable clearer communication with patients, medical staff and pharmacists. His presentation reviewed findings in a white paper authored by ASBM entitled, “It’s All About the Name: What is the Imperative of Adopting Unique Names For Biologic and Biosimilar Therapeutics?” The paper explains how biologic medicines are different from traditional chemical drugs and present unique safety concerns. Dolinar’s presentation in Ottawa followed a presentation earlier in the week at the DIA conference in Boston and furthered the dialogue with the international community towards a consensus among stakeholders on the need for unique names for biosimilars.

“Our research in the United States clearly indicates that physicians familiar with biologics know minor changes can make a big difference for sick patients,” said Dolinar. “Cases have occurred wherein a prescribing physician has mistakenly omitted the distinguishing prefix, resulting in a patient receiving the wrong medication, at the wrong dose. Instituting a system of unique names for biologic medicines will achieve the common goal of enhancing access to life-changing therapies, while also protecting the safety of the patients,” Dolinar concluded.

The findings shared were also expressed in a March 20th letter directly to Dr. Balocco Mattavelli, INN Program Manager at the WHO in Geneva. Dr. Balocco joined Dr. Dolinar and ASBM Executive Director Michael Reilly, along with a hospital pharmacist, and the Chair of the International Alliance for Patient Organizations (IAPO) at the Ottawa forum.

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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 and individuals from patients to physicians, innovative medical biotechnology companies, 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.

For more information, please contact:
Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
E: Michael@safebiologics.org

EuropaBio joins the Alliance for Safe Biologic Medicines

June 27, 2013

WASHINGTON, DC- The Alliance for Safe Biologic Medicines (ASBM) 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. Its members are involved in research, development, testing, manufacturing and commercialisation of biotechnology products and processes, and have a wide range of activities: human and animal health care, diagnostics, bio-informatics, chemicals, crop protection, agriculture, food and environmental products and services.

“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 Alliance for Safe Biologic Medicines. “We are pleased to have such an authoritative international partner who brings an experience with biosimilars that does not currently exist in the U.S. We will lean heavily on EuropaBio and its members to better understand the approach taken in the E.U. that has led to the successful introduction of biosimilars.”

In April 2013, the Process on Corporate Responsibility in the field of Pharmaceuticals, spearheaded by Commission Vice-President Antonio Tajani, published its long-awaited report on biosimilars. As members of the initiative, EuropaBio worked alongside the Commission and other stakeholders on the consensus document, which discusses the specifics around biosimilar medicinal products, the requirements for their marketing authorization in the EU, their market performance, and the necessary conditions within the EU pharmaceutical market to ensure informed and adequate use of these medicines.

The Alliance for Safe Biologic Medicines has had an established International Advisory Board for the purpose of providing ASBM’s Chairman, member organizations, and the general public guidance and expertise as the FDA moves forward to implement a pathway for biosimilar medications. However, the partnership with EuropaBio furthers that mission by serving as an important resource as they evaluate the future of biologics and biosimilars in the United States, Canada, and the EU.

“Countries across the globe have gathered much data which can, at a minimum, help inform our own policy makers,” Executive Director of ASBM, Michael Reilly, stated. “The ASBM will take advantage of the opportunity to learn from their experiences, both positive and negative.”

Miriam Gargesi, Director of Healthcare at EuropaBio added: “We look forward to working with ASBM to continue educating the public on the opportunities and challenges associated with biotechnology, including biologic and biosimilar medicines. The development and manufacturing process for all biologic medicines, including biosimilars, is more complex compared to the processes associated with generics and other chemical, small molecule products. It is therefore necessary that a robust regulatory system and adequate label transparency are in place for all biological medicines, to ensure that physicians have access to and a good understanding of the most appropriate treatments for their patients.”

###

About the Alliance for Safe Biologic Medicines:
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, 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.

For more information, please contact:

Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
E: Michael@safebiologics.org

Rosalind Travers
Communications Manager, EuropaBio
Phone: +32 2 739 1173
GSM: +32 (0) 478 680 301
E: r.travers@europabio.org

EuropaBio joins the Alliance for Safe Biologic Medicines

June 27, 2013

WASHINGTON, DC- The Alliance for Safe Biologic Medicines (ASBM) 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. Its members are involved in research, development, testing, manufacturing and commercialisation of biotechnology products and processes, and have a wide range of activities: human and animal health care, diagnostics, bio-informatics, chemicals, crop protection, agriculture, food and environmental products and services.

“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 Alliance for Safe Biologic Medicines. “We are pleased to have such an authoritative international partner who brings an experience with biosimilars that does not currently exist in the U.S. We will lean heavily on EuropaBio and its members to better understand the approach taken in the E.U. that has led to the successful introduction of biosimilars.”

In April 2013, the Process on Corporate Responsibility in the field of Pharmaceuticals, spearheaded by Commission Vice-President Antonio Tajani, published its long-awaited report on biosimilars. As members of the initiative, EuropaBio worked alongside the Commission and other stakeholders on the consensus document, which discusses the specifics around biosimilar medicinal products, the requirements for their marketing authorization in the EU, their market performance, and the necessary conditions within the EU pharmaceutical market to ensure informed and adequate use of these medicines.

The Alliance for Safe Biologic Medicines has had an established International Advisory Board for the purpose of providing ASBM’s Chairman, member organizations, and the general public guidance and expertise as the FDA moves forward to implement a pathway for biosimilar medications. However, the partnership with EuropaBio furthers that mission by serving as an important resource as they evaluate the future of biologics and biosimilars in the United States, Canada, and the EU.

“Countries across the globe have gathered much data which can, at a minimum, help inform our own policy makers,” Executive Director of ASBM, Michael Reilly, stated. “The ASBM will take advantage of the opportunity to learn from their experiences, both positive and negative.”

Miriam Gargesi, Director of Healthcare at EuropaBio added: “We look forward to working with ASBM to continue educating the public on the opportunities and challenges associated with biotechnology, including biologic and biosimilar medicines. The development and manufacturing process for all biologic medicines, including biosimilars, is more complex compared to the processes associated with generics and other chemical, small molecule products. It is therefore necessary that a robust regulatory system and adequate label transparency are in place for all biological medicines, to ensure that physicians have access to and a good understanding of the most appropriate treatments for their patients.”

###

About the Alliance for Safe Biologic Medicines:
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, 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.

For more information, please contact:

Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
E: Michael@safebiologics.org

Rosalind Travers
Communications Manager, EuropaBio
Phone: +32 2 739 1173
GSM: +32 (0) 478 680 301
E: r.travers@europabio.org

Quality, Manufacturing Transparency Key to Avoiding Biologic Drug Shortages: Dolinar Addresses 49th Annual DIA Conference

June 25, 2013

BOSTON, Mass. – Speaking at the 49th Annual Drug Information Association (DIA) Conference, Dr. Richard Dolinar, chairman of The Alliance for Safe Biologic Medicines (ASBM), presented an analysis of past drug shortages and discussed how policies toward biologic drugs can be developed to guard against short supply. Dr. 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.”

“Prescribers have an important role to play in terms of offering a clinical, evidence-based perspective on the safe use of biologics,” said Dr. Dolinar. “As a prescriber, I will pay attention to a manufacturer’s track record on quality and constancy of supply to ensure the best outcomes for my patients.”

In his presentation, Dr. Dolinar discussed the findings of a 2011 Food and Drug Administration (FDA) analysis that attributed a majority of drug shortages to manufacturing problems and quality concerns. Of those shortages, 89 percent occurred among sterile injectables, which share a delivery mechanism with biologics.

He also referenced a 2013 study by University of Pennsylvania researchers, which found that 83 percent of oncologists had experienced drug shortages in the past six months. Of those physicians, 79 percent had to switch patients to different medicines, and 43 percent had to delay treatments.

“Shortages that force physicians to postpone treatment or switch patients to less effective medication are a serious risk to patient health,” said Dr. Dolinar.

Dr. Dolinar also stressed that giving biosimilars distinct non-proprietary names different from their reference biologic is essential for holding manufacturers responsible for their products, accurately attributing adverse events, and maintaining a safe biotech drug supply.

“Manufacturing transparency is vital. We cannot confuse problems with one biosimilar product with complications from another,” Dr. Dolinar concluded. “We must be able to distinctly identify products in order to partner effectively with patients, manufacturers, and FDA to keep the biotech drug supply safe and effectively treat disease.”

The DIA 2013 49th Annual Meeting is the largest global multidisciplinary event for professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related products. The DIA Annual Meeting covers all aspects of the life sciences industries offering more than 250 sessions on hot topics and is key for individuals in the industry.

See Dolinar’s presentation.

See DIA conference highlights here.

 

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Baltimore Sun: In debate over ‘biosimilars,’ patient safety must come first

May 22, 2013

In 1988, I became extremely ill. I had many tests, saw many doctors and was given various medicines. Some caused allergic reactions. Through it all, I remained sick — and actually became worse.

Eventually, I was diagnosed with autoimmune hepatitis, a very rare disorder. Much of the information I read said I had about 10 years to live.

Making matters worse, I was soon diagnosed with another autoimmune disease, rheumatoid arthritis (RA). My treatment options for RA were severely limited because of my autoimmune hepatitis, as most of the RA drugs would filter through the liver and could initiate another attack.

The good news is that my doctor found a new “biologic” drug that effectively treated my RA without producing allergic reactions. With my autoimmune hepatitis thankfully in remission, I am now living a full and productive life thanks to this breakthrough. I know first-hand that the right medicine makes all the difference, especially for patients like me with multiple conditions.

Read the full article here.

Interview with Bloomberg BNA

May 16, 2013

Executive Director Michael Reilly spoke with Bloomberg BNA on the challenges facing the biosimilars process both in the U.S. and abroad.

View the Video Insights interview here.

Interview with Bloomberg BNA

May 16, 2013

Executive Director Michael Reilly spoke with Bloomberg BNA on the challenges facing the biosimilars process both in the U.S. and abroad.

View the Video Insights interview here.

Capitol Weekly (Sacramento): In search of affordable health care

April 26, 2013

By Gerald Felando

Affordable, quality health care is a mainstay topic in today’s media and will continue to be, especially here in Sacramento. As a dentist, cancer survivor and former member of the California Assembly, I know the importance of creating policy that is patient-centered. The delivery of optimal health care for patients is constantly evolving and recent developments are some of the most profound I’ve witnessed in my career.  However, these futuristic changes are also bringing concerning consequences related to patient safety and welfare.

Innovative, scientific advancements have led to the creation of more effective prescription drugs.  Drugs are now being created from living organisms to treat cancer, HIV/AIDS, MS, Parkinson’s and many other debilitating illnesses with remarkable results.

These advanced drugs, known as biologics, contain an incredibly high level of molecular complexity compared to traditional drugs that are chemical-based.  And unlike chemical drugs, there is no generic form of a biologic. Biosimilars are similar to the biologic they aim to replicate, but they are not the same and they are not generic because do not utilize the same living cell line, production process, or raw material as the biologic.  Even the smallest difference in the structure of a biologic medicine and its attempted copy can have a significant impact on a patient.

Patients, physicians and pharmacists have to work collaboratively when battling a serious disease or sickness, especially when the patient is being treated with complex biotech drugs. Because communication between the three parties is so critically important, the California Legislature has introduced a bill that puts safeguards in place when it comes to the substitution of biosimilar medications.

Senate Bill 598 ensures patient safety by requiring basic notification when biosimilars are substituted for biologics, giving pharmacists five days after the switch occurs to notify the patient’s physician.

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.

Biosimilars will be available to patients at lower costs and the cost-savings are very important. As someone who treats patients from all economic backgrounds and has undergone cancer treatments myself, I want patients to receive the best care for the lowest cost, but never at the price of sacrificing their health and safety.

Patients and their families deserve and expect to receive the best health care in the world.  And extraordinary advancements are being made every day to make that goal a reality.  Let’s ensure patient safety across California when it comes to biologic and biosimilar medicines and require pharmacists to notify physicians when a life-saving medicine is switched for something else.

Gerald N. Felando served in the California State Assembly from 1976-1992.  He currently resides in San Pedro.  Felando is a consumer & senior advocate for state and federal public policy.

Capitol Weekly (Sacramento): In search of affordable health care

April 26, 2013

By Gerald Felando

Affordable, quality health care is a mainstay topic in today’s media and will continue to be, especially here in Sacramento. As a dentist, cancer survivor and former member of the California Assembly, I know the importance of creating policy that is patient-centered. The delivery of optimal health care for patients is constantly evolving and recent developments are some of the most profound I’ve witnessed in my career.  However, these futuristic changes are also bringing concerning consequences related to patient safety and welfare.

Innovative, scientific advancements have led to the creation of more effective prescription drugs.  Drugs are now being created from living organisms to treat cancer, HIV/AIDS, MS, Parkinson’s and many other debilitating illnesses with remarkable results.

These advanced drugs, known as biologics, contain an incredibly high level of molecular complexity compared to traditional drugs that are chemical-based.  And unlike chemical drugs, there is no generic form of a biologic. Biosimilars are similar to the biologic they aim to replicate, but they are not the same and they are not generic because do not utilize the same living cell line, production process, or raw material as the biologic.  Even the smallest difference in the structure of a biologic medicine and its attempted copy can have a significant impact on a patient.

Patients, physicians and pharmacists have to work collaboratively when battling a serious disease or sickness, especially when the patient is being treated with complex biotech drugs. Because communication between the three parties is so critically important, the California Legislature has introduced a bill that puts safeguards in place when it comes to the substitution of biosimilar medications.

Senate Bill 598 ensures patient safety by requiring basic notification when biosimilars are substituted for biologics, giving pharmacists five days after the switch occurs to notify the patient’s physician.

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.

Biosimilars will be available to patients at lower costs and the cost-savings are very important. As someone who treats patients from all economic backgrounds and has undergone cancer treatments myself, I want patients to receive the best care for the lowest cost, but never at the price of sacrificing their health and safety.

Patients and their families deserve and expect to receive the best health care in the world.  And extraordinary advancements are being made every day to make that goal a reality.  Let’s ensure patient safety across California when it comes to biologic and biosimilar medicines and require pharmacists to notify physicians when a life-saving medicine is switched for something else.

Gerald N. Felando served in the California State Assembly from 1976-1992.  He currently resides in San Pedro.  Felando is a consumer & senior advocate for state and federal public policy.

The Sun Sentinel: Low costs medicines could jeopardize patient health

April 26, 2013

In Florida’s House and Senate, lawmakers are currently working on legislation that would enable patients to purchase lower-cost alternatives to some of today’s most-advanced medicines.

Unfortunately, a recent amendment to the legislation undermines the physican-patient relationship. It’s critical for lawmakers to revert to their original proposal.
The legislation under consideration deals with a new class of medicines known as “biologics.”

Unlike conventional drugs, which are made using basic chemical reactions, biologics are actually grown using living organisms. So they’re much more complex. Consequently, when the patent on a biologic expires, competitors aren’t able to make exact copies. But they can come close — so imitation biologics are called “biosimilars” instead of “generics.”
Under federal law, the Food and Drug Administration will soon begin approving biosimilars. But the agency doesn’t plan to issue any product-specific guidance to physicians or pharmacists prior to approving these drugs. And, it’s not within the FDA’s jurisdiction to tell states how to address the substitution of interchangeable biosimilars at the pharmacy — that responsibility falls to the state.

When Florida lawmakers in both chambers started work on their bills, they were model pieces of legislation — striking a balance between ensuring patient safety, and creating open access for more affordable new treatments.

The original bills stipulated Florida pharmacists would only be allowed to substitute a biosimilar for its brand counterpart if the FDA had certified the medicine as interchangeable with the innovator biologic.

The human body is complicated, of course, so it’s possible that some biosimilars — even those deemed interchangeable by the FDA — will not work properly for certain patients, and because of the interaction of these treatments with a patient’s immune system serious consequences can result.

The original legislation also required pharmacists to notify patients if a substitution had been made. And, because adverse reactions may not manifest themselves immediately, the bill also asked pharmacists to maintain dispensing records for four years. In the event that a biologic or biosimilar does not provide the intended treatment outcome, such records will prove vital.

Finally, and most importantly, the bill required pharmacists to notify prescribing physicians within ten days if a substitution had been made. It’s important to underscore that this notification is required after the patient has already received the biosimilar.
These are all commonsense ssafeguards. They ensure that patients can access these less expensive new modifications safely.

But over the past week, House and Senate lawmakers have stripped the physician notification  from their bill. This doesn’t make sense — it ignores the most fundamental aspect of protecting the patient by cutting doctors out of the loop.

This change undermines patient safety. Biologics are incredibly complex — on average, they contain 1,000 times the number of atoms found in conventional chemical drugs. Doctors, especially those treating patients with multiple chronic or autoimmune conditions, need to know when their patients walk away from the pharmacy counter with a different medicine than the one they prescribed.

This change also undercuts physician autonomy and ignores the importance of transparency. In order to effectively treat their patients and protect against unintended health effects, doctors have the right to know if a substitution is made.

In both the House and the Senate, the earlier draft of the bill puts patients first. As lawmakers finalize this measure, it’s critical that they fulfill their responsibility to keep patients at the cent of this debate, and to make sure that the legislation passes with all protections intact.

Peter J. Pitts, a former FDA Associate Commissioner, is the president of the Center for Medicine in the Public Interest.

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