Who We Are
The Alliance for Safe Biologic Medicines is an organization of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines and others, who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of the Alliance to serve as an authoritative resource center of information for the public, medical community, the FDA and other state and federal policymakers during the implementation of the biosimilars approval pathway and beyond.
Biologics are advanced prescription drugs to treat cancer, rheumatoid arthritis and other debilitating diseases. In November 2010 the Food and Drug Administration began consultation with patient groups, physicians and industry on how to approve the first copies of these drugs, known as follow-on biologics or biosimilars. As the FDA moves forward in implementing this pathway, the Alliance for Safe Biologic Medicines will work to ensure patient safety remains the priority.
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.