Companies that make copies of blockbuster biologic medicines have a marketing problem.
Almost a quarter of doctors in Europe can’t define or haven’t heard of biosimilars, according to a survey by the Alliance for Safe Biologic Medicines, an Arlington, Virginia-based trade and patient group. The survey, published today, was carried out among 470 physicians in France, Germany, Italy, Spain and the U.K.
This is bad news for makers of biosimilars, who have been trying to take market share from originators of lucrative drugs in Europe since 2006. Celltrion Inc. and Hospira Inc. last year won European backing to sell the first copies of Johnson & Johnson (JNJ)’s Remicade, a $6.7 billion arthritis therapy. Given lower development costs, Celltrion is able to charge 30 percent less for its product, called Remsima.
“The understanding of biosimilars is not yet widespread among physicians,” said Nathalie Moll, secretary general of EuropaBio, a biotechnology trade group in Brussels. To help remedy the situation, EuropaBio plans to raise awareness among doctors and regulators, according to Moll.
More than half of respondents also said that having the same International Nonproprietary Name for the copy and original drug implies that the medicines are identical.
In fact, making exact copies of biologics, unlike traditional chemically-derived drugs, is practically impossible as even batches made by the same manufacturer will have slight variations. As in winemaking, a host of factors can affect the product, such as where it was made and the temperature at the time of production.
Prescribing by INN may lead to patients receiving a medicine not intended for them, and can lead to side effects being attributed to the wrong drug, ASBM said.
“The use of distinguishable INNs for all biologics, including biosimilars, is critical to further strengthen and facilitate patient safety,” the ASBM said in a statement.
Manufacturers have been slower to submit biosimilars to U.S. regulators given uncertainty around approval guidelines. The Food and Drug Administration has had “no flood of applications,” contrary to expectations, Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, said at a Bloomberg health-care summit in New York last month.
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