Interview with Bloomberg BNA

May 16th, 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 26th, 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 26th, 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.

ASBM Executive Director Quoted in FDA News

April 17th, 2013

ASBM Executive Director Michael Reilly was quoted in the FDA News article by Robert King.

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.

Sun Sentinel: Keep doctors informed and patients safe

April 4th, 2013

ASBM Advisory Board Member Dr. Bruce Rubin op-ed in the Florida Sun Sentinel:

The diagnosis of a chronic, neurological condition like Multiple Sclerosis can be a shock to a patient and his or her family. From my experience as a neurologist, families often have a barrage of questions after receiving this news: Can it be treated? How will the disease progress? What are the health care options? Thanks to breakthroughs in the field of biotechnology, we are now able to offer them hope. Biotechnology has changed the game for neurologists. Several biologic medicines have been developed to reduce relapses of MS and slow down damage to the central nervous system, caused by the disease’s progression. Biologics are cutting-edge because they are manufactured with living cells, and they are able to specifically target the immune system in ways that chemical drugs cannot. Besides MS, biologics are also used to treat cancer, Parkinson’s disease, rheumatoid arthritis and autoimmune diseases.

In the laboratory, scientists manipulate living cells to grow these large, complex, genetically engineered molecules. A finished biologic product is thousands of times larger than a chemical drug like Ibuprofen. The complicated structure of these medicines makes them more susceptible to environmentalchanges and requires cautious handling by medical professionals.

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.

House Bill 365 and Senate Bill 732 would help keep doctors aware of any substitutions made by pharmacists for interchangeable 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.

Dr. Bruce S. Rubin is a board certified neurologist, voluntary assistant professor of Clinical Neurology at the University Of Miami Miller School of Medicine and director of the Spasticity Clinic at Jackson Memorial Hospital.

Dr. Dolinar Presentation at Biosimilar Insulins Impact on Clinical Practice Meeting

March 15th, 2013

On March 14, Dr. Dolinar gave a presentation on a “Clinicians’ Perspective on Biosimilars” at the Biosimilar Insulins Impact on Clinical Practice Publications Roundtable Meetings in Dallas.

View his presentation here.

BNA: Branded, Generic Drugmakers Spar Over State Biosimilars Legislation

March 12th, 2013

ASBM Executive Director Michael Reilly was quoted in a BNA article on biosimilar state legislation.

Reproduced with permission from Pharmaceutical Law & Industry Report,11 PLIR 286 (March 1, 2013). Copyright 2013 by The Bureau of National Affairs, Inc. (800-372-1033) <http://www.bna.com>

(BNA) — Will State Laws Thwart Use of Biosimilars?

Major Development: Several states are considering legislation that would require physician notification when a patient is switched from a branded biologic to an interchangeable biosimilar.

Brand, Generic Positions: Amgen, Genentech, and their allies are pushing for the state legislation. Meanwhile, generic companies say the state legislation is a “preemptive strike” by branded drug companies to limit access to these products.

Branded drug companies are pushing for state legislation that would place certain restrictions on biosimilars, while generic drug companies and pharmacy benefit managers say these proposals would limit patient access to these drugs and make them more expensive.

The 2010 health care reform law, through its Biologics Price Competition and Innovation Act (BPCIA), created a pathway for the Food and Drug Administration to approve follow-on biologic drugs, or biosimilars, but the agency still is working on implementation. The agency issued three draft guidances on biosimilars in 2012 (10 PLIR 173, 2/10/12) and has yet to issue guidance on the issue of interchangeability.

Brand biologic companies, including Amgen and Genentech, are pushing for state legislation on biosimilars that would require a physician to be notified when a pharmacist switches a patient from a brand biologic to an interchangeable biosimilar. Meanwhile, generic companies say state legislation should wait until after FDA is finished implementing the pathway so that legislation does not end up restricting access to these drugs.

According to the Generic Pharmaceutical Association (GPhA), bills are or have been under consideration in Arizona, Arkansas, Colorado, Florida, Indiana, Maryland, Massachusetts, Mississippi, North Dakota, Oregon, Pennsylvania, Texas, Virginia, and Washington.

Branded Company Campaign
Amgen Inc. said in a statement Jan. 25 that it is “helping to educate state policymakers” on biosimilars “to ensure that physicians, patients, and pharmacists share important information about biologic substitution.”

Amgen said physicians should be notified when a brand biologic is substituted with an interchangeable biosimilar. The company said it believes that a “notification process that does not impose an undue burden on the pharmacist is in the patient’s best interest.” The company said physician notification would “close the gap in biologic traceability that could otherwise be created.”

“Amgen endorses state policies that would put patients first and, in doing so, increase confidence in the biosimilar pathway. It is important to have consistent policies in place at the federal and state level,” Scott Foraker, vice president and general manager of biosimilars at Amgen, said.

Amgen said state efforts to create safe substitution rules for interchangeable biologics will help accelerate the successful implementation of the U.S. biosimilars pathway.

Biologic medicines are different from traditional chemical drugs in several important ways, Amgen said. Biologics are so complex that they usually can only be made by a living cell. In fact, when made by different manufacturers, they differ from each other, the company said.

Biosimilars also have very large molecules compared to chemical drugs and can be more sensitive to storage and handling, Amgen said. As a result, biologic medicines have the potential to cause an unwanted immune response, which can show up months after taking the medicine, the company said.

Amgen said it believes state pharmacy laws must enhance safety monitoring of substituted biologics.

Interchangeability
Michael Reilly, executive director of the Alliance for Safe Biologic Medicines (ASBM), told BNA that the states are moving forward with biosimilars legislation as a way to address both interchangeable and noninterchangeable biosimilars.

ASBM is composed of diverse health care groups and individuals working to ensure patient safety, according to its website. Members of the alliance include Amgen and Genentech.

Reilly said if a state does not have legislation in place, noninterchangeable biosimilars could be substituted for brand products.

“If you look to Europe as a model,” they do not have automatic substitution or interchangeability and they encourage physicians to begin patients on biosimilars rather than on a brand biologic so that patients are not at risk from switching from the brand to the biosimilar, Reilly said.

Interchangeable biosimilars do not exist and FDA has not yet established a pathway, Reilly said. “Nobody knows what an interchangeable is,” he said. “This is about when the first biosimilar is approved and how it is treated.”

“There has been a lot of rhetoric around what an interchangeable is, but there is no experience with interchangeability anywhere in the world,” Reilly said.

Opposition for State Legislation
Ralph Neas, president and chief executive officer of GPhA, told BNA that Amgen and Genentech are pushing for state legislation on biosimilars and are “engaged in preemptive strikes to limit access to safe, effective, and affordable biosimilars.”

Neas said if this effort is successful, it would decrease cost savings from these products and “it would have a destructive impact on many Americans,” as well as state budgets.
Amgen and Genentech are “raising questions” about these products and undermining trust in these new products, Neas said. These companies are “already trying to stack the deck in their favor.”

Neas said FDA still is implementing the biosimilars pathway and states could enact legislation after the pathway is created. He said that when FDA does approve an interchangeable biosimilar, patients and physicians should not have to deal with “roadblocks.”

“The more attention this issue receives, the more likely Genentech and Amgen’s efforts will fail,” Neas said.

“Biosimilars are not new and have been used in dozens of countries,” Neas said. “There are no reports of adverse events” in these countries and “the safety issue has been addressed already.”

“It’s up to FDA and not Amgen and Genentech,” Neas said.

On Feb. 6, GPhA praised Mississippi for voting down a bill that would make it more difficult for consumers to get access to biosimilar medicines. “With nearly $11 million spent in 2011 alone on costly biologic medicines in their state Medicaid program, Mississippi state legislators know that creating barriers between patients and newer, low-cost versions of these therapies is not right for their state,” Neas said in a Feb. 6 statement.

Neas said that “if passed, these measures would be harmful [to] their constituents and wreak havoc on their state budget.”

“Like the American Cancer Society and others, we believe that the time to consider laws on biosimilars is after FDA has laid out a meaningful roadmap for the safety rules for these new medicines,” Neas said. “To do so before those regulations are released is a Trojan Horse: a measure to kill competition in the name of safety.”

FDA Commissioner Margaret A. Hamburg said at GPhA’s annual meeting Feb. 22 that “efforts to undermine trust in these [biosimilar] products is worrisome and represents a disservice to patients who could benefit from these lower cost treatments.”

“The high standard for approval of biosimilar and interchangeable products means that patients and health care professionals can be assured that when those products go to market, they will meet the standards of safety, efficacy, and high quality that everyone expects and can count on,” Hamburg said.

PCMA Weighs In
The Pharmaceutical Care Management Association (PCMA) Jan. 31 said in a statement that the state proposals would increase costs for employers, public health programs, and patients, and restrict access to lower-cost alternatives. PCMA represents pharmacy benefit managers.

PCMA said the campaign by branded biologic manufacturers for these state proposals “is designed to preempt the FDA’s process by creating a flurry of state laws that will conflict with the FDA’s forthcoming national standards.”

“Creating a patchwork of dueling state and federal rules would make it harder for pharmacists to know when they can dispense a biosimilar,” PCMA said. That would raise costs for patients and their employers, who typically cover two-thirds of prescription drug benefit costs, the group said.

Mark Merritt, president and chief executive officer of PCMA, said “campaigning to restrict the use of biosimilars enriches brand manufacturers at the expense of the employers, public health programs, and patients who need access to lower cost medicines.”

The American Cancer Society Cancer Action Network (ACS CAN) said in a January statement that it is not taking a position yet on changing state pharmacy laws pertaining to the interchangeability, substitution, and related biosimilars patient protections until ‘we better understand the many complex regulatory and scientific issues as well as the current state of state pharmacy practice acts.”

ACS CAN said it “is very supportive of the advancement of both biologics and biosimilars because of their enormous potential as effective tools in the fight against cancer and the improvement of the quality of life for patients.”

By Bronwyn Mixter

The above story appeared in: Pharma. Law & Industry Report