Safe Biologics

On November 25 in Madrid, Spain, the Alliance for Safe Biologic Medicines presented results from a survey of European physicians at the “1^ST EuropaBio – ASEBIO Meeting on Innovation and Biological Therapies” at the Spanish Ministry of Health, Social Services and Equality. The event, hosted by EuropaBio and the Spanish Bioindustry Association (ASEBIO), included regulators from the Spanish Ministry of Health, physicians from Spanish oncology and rheumatology societies, representatives from a hospital pharmacist organization and patient groups.

ASBM Executive Director Michael Reilly shared the results of the E.U. physicians survey conducted at the end of 2013, and also for the first time shared the specific responses from the Spanish physicians who were included in the survey.  The ASBM survey is the first of its kind in Europe and provided valuable data on physicians’ views and understanding of biosimilar medicines.  Over 470 nephrologists, rheumatologists, dermatologists, neurologists, endocrinologists, and oncologists from the big 5 western European countries that also included France, Germany, Italy and the U.K.

“Physicians in Spain and across Europe have a solid understanding of biologic medicines, however, there is a clear need for further education when it comes to biosimilars,” said Reilly in his presentation. “The Spain data as well as the data from the larger survey make it clear that physician misconceptions about biosimilars and the prescribing practices they utilize, indicates a strong need for a clear naming scheme with distinguishable non-proprietary names for all biologics.”

In the presentation, Reilly pointed out while Spanish physicians have a better understanding of biologics and biosimilars than their European counterparts, only 28% of Spanish physicians are “very familiar” with biosimilars.  In addition, almost a quarter of Spanish physicians surveyed – 23% – could not define or had not heard about biosimilars before.

Physicians in Spain overwhelmingly indicated that they should have the sole authority to decide the most suitable biologic medicine for their patients with 88% agreeing that they alone should be the decision-maker compared to 68% of survey respondents from France, Germany, Italy and the U.K.  Additionally, Spanish respondents strongly believed that they should be notified if a pharmacist dispensed a biologic other than the one they prescribed – 92% said it is very important or critical that they be notified – compared to the 54% average of the other European countries surveyed.

View Mr. Reilly’s presentation here.

On November 18, Dr. Gewanter responded to a piece in The Hill by Citizens Against Government Waste, by pointing out that the author Tom Schatz, wrongly categorized biosimilar approval as a trade/competition issue when it is a really a patient safety issue.

In his letter Dr. Gewanter wrote:

As a practicing pediatric rheumatologist and chairman of the Alliance for Safe Biologic Medicines, I wish to correct some misinformation published in your Nov. 11 article, (“Biosimilar approval is long overdue”, by Tom Schatz.) Biologic medicines have helped millions of patients suffering from cancer, rheumatoid arthritis, and other conditions, and the author is correct in his basic assertion that biosimilars- attempts to replicate them- will offer patients new ways to access versions of these therapies.

But Mr. Schatz makes a common error in equating biologic medicines with chemical medicines.  Unlike generic copies of chemical medicines, the complexity of biologics means that an attempted copy will never be identical. A biologic produced from a different cell line can, at most, be “similar”, hence the term “biosimilars”. This scientific reality is why biologics cannot simply be treated as generics by regulators.  Even minor differences can create adverse impact in patients, including unwanted immune responses. How similar is “similar enough” to safeguard patient safety? The Food and Drug Administration (FDA) has wisely taken its time in drafting approval criteria and other guidance to answer that question accurately.

Requiring biosimilars to be distinguishable not only from the biologic they aim to replicate, but also from other biosimilars, is smart for everyone: patients and physicians know which medicine they are receiving. Pharmacists can avoid inadvertent or inappropriate substitution. Regulators can better track adverse events and efficacy of products.  Manufacturers will learn more, and be more accountable for their products.

Since the use and manufacture of biologics is global, the need for distinguishable naming is global. This is why the World Health Organization has proposed a global solution- adding a four letter “biological qualifier” (BQ) to the International Nonproprietary Name (INN) of each biosimilar. All patients deserve these protections, regardless of in which country they receive treatment.

Mr. Schatz claims the WHO’s proposal will “confuse providers and users”. To the contrary, it will add much-needed clarity:

A 2013 survey by ASBM of 470 European physicians showed that 24% use only the INN when prescribing, potentially resulting in patients receiving the wrong medicine. When reporting adverse events, 17% use only the INN, potentially resulting in false attribution of adverse events. Europe’s solution has been to track adverse events by batch number, yet only 40% of its physicians use these consistently, while 27% never use them.

More than 30 biosimilars are now available in Thailand to stimulate red blood cell production in cancer patients. One (or more) caused a deadly condition known as Pure Red Cell Aplasia (PRCA). Since all share the same INN, being able to attribute adverse effects – and efficacy – is critical.

Distinguishability isn’t confusing for doctors and patients; ambiguity is.

This is why ASBM joined more than 50 patient and professional organizations, by signing a letter in August urging FDA to follow the WHO’s lead and support distinguishable names for biosimilars.

When balancing potential cost savings, access to care, or administrative speed, against patient safety- patient safety must always trump all other concerns.

 

 

 

 

 

On November 12th Medscape posted an interesting video interview with FDA Commissioner Dr. Margaret Hamburg.

Watch “FDA’s Hamburg on Balancing the Risks, Benefits for 310M Patients” here.

Rep. Bobby Rush: “Biosimilars – Another Untold Story of the Affordable Care Act”

In a November 6, oped for the Huffington Post, Rep. Bobby Rush (D-Ill) made the case for physician- pharmacist communication when it comes dispensing biosimilars. He wrote:

“While the nuances of the legislation and rules considered in each state may vary, one underlying issue has been raised in every state discussion thus far: the need to ensure active pharmacist-prescriber communications when it comes to dispensed biologics and biosimilars.

Prescribing physicians need to know which biologic has been dispensed to support patient care in the event that a patient has an adverse response and has received multiple biologics. This is relevant not only to retail dispensed biological products, where a pharmacist and physician may not normally communicate about the history of a patient’s medicines, but also to mail-order prescriptions where the occurrence of pharmacist and prescriber communication is even less likely to take place.”

Read the full piece here.