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June 08, 2016

Biosimilars: Safe and Effective? Global Doctors Split on Trust

SERMO, the leading global social media network exclusively for doctors and largest health care provider polling company, announced today that in a May poll of 3,849 global doctors, 53 percent (2,043 doctors) would not or do not feel like they have enough educational information to prescribe biosimilars to their patients. For an infographic of the full results of the poll, please click here.

NEW YORK — Biologic drugs are derived from genetically modified cells, and are generally very big and complex molecules – regularly 200 to 1000 times bigger than the more common category of medicine called small-molecule drugs. Biologics include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.

They can address a range of diseases including cancer, diabetes, and anemia. A biosimilar is a biological that is shown to be highly similar to another approved biological product. They are different from generics in that they are not exact copies of other products under a different name.

Biosimilars are an emerging market, with two agents approved in the United States and 22 in European countries. In the U.S., the two biosimilars that have been approved to date are Zarxio, a biosimilar to Neupogen (filgrasim) and Inflectra, a biosimilar of Remicade (infliximab).

Doctors need to see more testing

The main concern that doctors expressed in the conversation that accompanied the poll on SERMO was the speed with which these products are going to market, and the lack of testing they face before being given to patients.

A U.S. rheumatologist who participated in the poll articulated the risk of adverse effects presenting in the general population, which may increase when products are fast-tracked – “The only way to determine safety that a biological does not produce unexpected adverse events in a large population is through extensive human testing. But, the ‘expensive’ human testing phase is the very corner that is being cut to make marketing biosimilars less expensive and accelerate their arrival on the market. High stakes gambling.”

A Venezuelan allergy and immunology specialist doubled-down on the need for clinical trials, saying “Biosimilars are not equivalent to small molecules, so they will not be able to have a real biological equivalence … they need phase III clinical studies (not only equivalence) to prove that they are as effective as the original molecule.”

One gastroenterologist in Greece stated, “Biosimilar agents are still untested, so safety and efficacy cannot be known without clinical trials… Unfortunately since initial testing has been skipped, biosimilars will probably have a negative effect on patient outcomes… After testing, they might prove safe and effective. But, that would require huge amounts of funds and a minimum of 10 years of studies.”

A U.S. rheumatologist also questioned the current scientific backing of biosimilars, “Are they safe and effective? Who knows? In order to save a buck, these – new compounds – are being approved for marketing for numerous diagnoses for which no studies have been performed… Each biosimilar is a 100% completely new compound. Approving such a totally new chemical compound to be marketed to treat potentially millions of patients with a half-dozen different diagnoses...Without thorough testing? ...Not for my child, thank you. Not for my patients. The FDA proposing taking very promising compounds and turning them into treatments is one step away from snake oil (which was also marketed without appropriate testing).”

A Spanish oncologist reiterated the sentiment, sharing “The important thing is that they are backed by powerful studies,” and a Canadian General Practitioner concluded “More studies and long term follow up are warranted before concluding safety.”

Doctors who have biosimilars are not confident in their efficacy

Doctors practicing in countries where biosimilars are approved shed light on their experiences with biosimilars to date, and the results were not promising.

According to a dermatologist in Mexico, “I have personally used biosimilars and they were a disappointment. [They are] not only ineffective, but also caused adverse effects. In Mexico, this is a major problem – widespread, nationwide.”

A Venezuelan Pediatrician also shared negative experiences, “Unfortunately right now in Venezuela, specialists are the only ones who get biosimilars, and their performance is 50% of the original.”

Even more tests may not convince physicians

A Mexican Occupational Medicine specialist stated unequivocally, “It is impossible that biosimilars will have the same effect as they are molecules produced by living tissue. In the same batch, there are differences in the molecules. The simple change of temperature can create variations, so imagine when it is not even the same colony, tissue, conditions etc…. it definitely can not be biosimilar to a small molecule.”

An ophthalmologist from the U.S. highlighted the differences that exist even between generics and original products, explaining, “Given the huge discrepancy between branded drugs and generics that we see in simple eyedrop formulations, I hate to think how different the biosimilars could be.”

An Irish rheumatologist commented, “Where I have a major concern is the extrapolation of indications. This is incorrect and has only come about due to health budget issues.”

A French intensive care physician noted, “It is difficult to say anything about drugs that have not been studied prior to marketing. Their absorption, pharmacokinetics, tolerance vary from one laboratory to another. There are many examples of side effects… The active molecule remains the same and is known but this is not enough to affirm the efficacy or tolerance of the drug.”

Given all the concerns, a Spanish General Practitioner raised an important question: “If you already have the original molecules, my opinion is that drug companies should focus their efforts on obtaining new molecules, not making "roughly equivalent" copies of existing ones. What is the advantage [of biosimilars] for patients?”

47 percent of doctors said they believe biosimilars will prove safe and effective enough to prescribe. 43 percent of doctors polled (1,670 doctors) said they would need more educational information on biosimilars before prescribing the agents to patients. 10 percent (373 doctors) reported that they would not prescribe biosimilars, even if provided more educational information about safety and effectiveness.

This SERMO poll was administered via email to a random selection of members of the SERMO community in 28 countries: Argentina, Australia, Austria, Canada, Chile, Columbia, Denmark, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy, Mexico, the Netherlands, New Zealand, Norway, Peru, Poland, South Africa, Spain, Sweden, Switzerland, United States and Venezuela. Participation was voluntary and results were kept anonymous. The margin of error is ±2 percent.

For more information on the methodology of SERMO polls, please go to http://www.sermo.com/polls.


About SERMO

SERMO is the leading social network for physicians – the world’s largest virtual doctors’ lounge where doctors talk real world medicine. SERMO’s mission is to revolutionize real world medicine by providing physicians a safe, private and trusted platform for free and open dialogue on an unprecedented global scale. SERMO has close to 600,000 fully verified and licensed members and is now available for doctors in 30 countries: the U.S., the U.K., Australia, Canada, Ireland, Mexico, South Africa, Spain, Italy, Argentina, the Netherlands, Denmark, Sweden, Norway, New Zealand, France, Finland, Colombia, Venezuela, Chile, Ecuador, Guatemala, Peru, Israel, Austria, Switzerland, Greece, Hungary, Poland and Germany. SERMO is also the world’s largest health care professional polling company with 1.8 million HCPs in both the social network and a digital research network, spanning 80 countries. SERMO conducts 700,000 surveys a year.

Learn more at www.SERMO.com.

Media Contacts: Racepoint Global
Liz Donovan Wells, +1-202-517-1386
ewells@racepointglobal.com
or
SERMO
Osnat Benshoshan
Chief Marketing Officer
osnat.benshoshan@sermo.com