Safe Biologics

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.

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 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.

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.