April 2013 Newsletter

July 21, 2013

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.


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.


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.


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.


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.


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.


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.


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.


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.


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.



Article in GEN Insight & Intelligence: Latest Biosimilar Guidance Raises More Questions. Quick FDA action just as unlikely as last year, when agency issued original policy advice.

July 9, 2013

Testifying before Congress in April, FDA Commissioner Margaret A. Hamburg, M.D., sought to reassure lawmakers: “We are developing a science-based process for bringing safe and effective biosimilar and interchangeable products to market, which should increase competition and create substantial savings for patients, healthcare providers, and insurers.”

More than a year after issuing three draft guidances on biosimilars, however, FDA has been unable to show industry and others little progress beyond a fourth draft guidance issued in March on formal meetings between the agency and biosimilar sponsors. And judging from comments by drug developers during a comment period that ended May 31, industry has numerous questions it wants FDA to address.

Read full article here.


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.

# # #

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.

 

# # #


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.


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