Would-be Biosimilars Makers Argue for One Product Name
Manufacturers of forthcoming biosimilars argue that their products should have the same international non-propriety name (INN) as the reference product, and do not need a unique qualifier to distinguish them from the brand version for the purposes of tracking.
Biosimilars should be treated no differently than the brand, as the products are shown to have the same clinical effect as their reference, said Juergen Schmider, vice president of global product safety at Hospira. He argued that even within batches of brand biologics, product differences crop up as manufacturing processes change, yet those companies do not need to add a qualifier to the name.
Schmider spoke out specifically against a proposal by the World Health Organization to add a randomly assigned four-letter qualifier to biosimilar INNs as a means to trace biosimilar prescriptions and patient responses.
A separate INN is not needed to track product use, despite some brand companies’ claims, Schmider told GPhA’s annual fall technical conference in Bethesda, Md., last week. Each biosimilar unit contains labeling features that distinguish it from the next product, and allow for extremely reliable tracking, he added.
The naming of biosimilars has proven a hotly contested subject as industry awaits the FDA’s promised guidance on the subject, and several companies have announced U.S. applications for biosimilars. None have been approved yet.
The Biotechnology Industry Organization endorsed the WHO proposal, and some brand manufacturers argue there is no comparison between manufacturing changes of existing biologics and the creation of a biosimilar. AbbVie, for example, has said that when manufacturing changes occur, they are done under extremely tight quality conditions that require the company to show any differences between batches as clinically meaningless. Biosimilars, on the other hand, are entirely different products from the reference, AbbVie argues.
Much is riding on how the agency ultimately decides the naming protocol. Schmider contends that a different INN would prove a barrier to the promise of biosimilars as a cost control, offering patients a cheaper alternative to the brand reference.
Meanwhile, Jim Roach, senior vice president of development at Momenta, blasted some states that already have enacted high barriers to the interchange between the products through restrictive substitution laws. He pointed specifically to laws that would require pharmacists to notify the prescribing physician and patient when a product is to be interchanged. Under these laws, a pharmacist cannot substitute a biosimilar if the physician explicitly requests otherwise.
Biosimilars should be treated as interchangeable, he said. Freedom from physician interference is vital to market acceptance, Roach argued. — Bryan Koenig
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.