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Name Game

Hospira follows Generic Pharmaceutical Association in fight over biosimilar names.

DANIEL S. LEVINE

The Burrill Report

“Biotech innovators have seized on that fact to argue that small differences can cause great harm and that biosimilars should be distinguished from reference products in their very name.”

Hospira, which boasts that it is the only U.S. based company selling a biosimilar in Europe or Australia, has added its voice to the fight over biosimilars naming and dragged the Bard himself into the fight.

In a policy paper, Sumant Ramachandra, senior vice president and chief scientific officer for Hospira makes the case for why the names used for biosimilars should be the same as the generic names used for the branded biologics.

“Shakespeare declared that a rose by any other name would smell as sweet, but the pharmaceutical world is different,” he writes. “A name means a great deal when it comes to medications, affecting everything from how clinicians perceive the drug to how pharmacists dispense it. In the specific case of biosimilars, a drug’s name can clearly signify whether or not it has met certain regulatory criteria and if (it is) officially considered ‘biosimilar.’”

The arguments in the paper closely follow a citizen’s petition that the Generic Pharmaceutical Association filed in September with the U.S. Food and Drug Administration calling for the FDA to implement a policy that all biosimilars carry the same international non-proprietary name as the referenced product. Though generic names for small molecule drugs are the same for the branded and generic product, things get a little sticky when it comes to biosimilars.

Unlike chemically synthesized drugs that can be analyzed to determine if a generic is the same as a branded product, biologics are derived from living cells. As such, two biologics derived from different cell lines may be very similar, but not identical.

Biotech innovators have seized on that fact to argue that small differences can cause great harm and that biosimilars should be distinguished from reference products in their very name so as not to cause a pharmacist or doctor to inadvertently replace a branded product with a biosimilar.

The Biotechnology Industry Organization has argued that unlike traditional generic drugs, biosimilars are also not interchangeable with reference products. “Patients could respond very differently to the innovative product and any biosimilar versions,” the organization has said. “Inadvertent substitution of one version of a medicine for another could have negative clinical consequences.”

Billions of dollars are likely at stake in how it all gets worked out for the simple fact that two biologics that share identical names are likely to be viewed as interchangeable. With the government now back open, and the implementation of the Affordable Care Act advancing, the FDA approach to biosimilars will once again become a focus. The FDA has the power to designate the non-proprietary names for biosimilars and the decision, as the GPhA argues, will affect patient access, market competition, and global standards.

Hospira is not the first to pull Romeo and Juliet into the debate over naming of biosimilars. But scientists should rely on science, and not poetry, to make their arguments. English majors may be lurking. For innovators, it’s not in Romeo and Juliet, but Othello, where Shakespeare may have it right on names.

Good name in man and woman, dear my lord, Is the immediate jewel of their souls. Who steals my purse steals trash; ‘tis something, nothing; ‘Twas mine, ‘tis his, and has been slave to thousands: But he that filches from me my good name Robs me of that which not enriches him And makes me poor indeed.



October 18, 2013
http://www.burrillreport.com/article-name_game.html

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