March 18 (Bloomberg) -- 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’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 involve 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.
The World Health Organization, which is responsible for INNs, held a meeting in Geneva on Oct. 22 where a point of discussion was the naming of biosimilars. Experts at the meeting largely agreed that a two-part naming system could be implemented, with a “biological qualifier” added to the INN for biosimilars.
In contrast, makers of biosimilars are opposing such a proposal. Novartis AG, which has a generics division, submitted a citizen petition to the U.S. Food and Drug Administration on Oct. 28 asking that biosimilars be identified by the same INN as the reference product.
“Assigning different INNs to products approved as biosimilars would introduce unncessary confusion into the healthcare system and could unintentionally communicate increased caution, unfounded risk or other regulatory reservations that are purely hypothetical,” Novartis said in the petition.
Manufacturers have been slower to submit new biosimilars to U.S. regulators given uncertainty around drug development guidelines. The FDA 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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