Bio-synonyms: describing biosimilars without saying ‘copycats’ or ‘knock-offs’

By Dan Stanton contact

- Last updated on GMT

Cool with 'cats? (iStock/Dixi_)
Cool with 'cats? (iStock/Dixi_)

Related tags: Biology

Terms such as ‘copycats’ and ‘knock-offs’ are inaccurate and misleading, say drugmakers. We ask therefore how industry and the media should refer to biosimilar products?

Earlier this year, biosimilar expert and fellow journalist Duncan Emerton expressed his strong dislike to the words ‘copycat’ and ‘knock-off’ when describing versions of biological products.

“These two words, phrases, clichés, whatever, you want to call them, have become media bywords for biosimilars. Both words are associated with counterfeit, sub-standard products. Like handbags, sunglasses and watches,”​ he said on The Biosimilarz Blog!

“Another word that gets used is clone,”​ he told Biopharma-Reporter, adding that once again “it's not great for describing biosimilars.”

As someone who writes about the biosimilar industry on an almost daily basis, I have often resorted to at least one of these hackneyed sayings under the bogus belief it adds a certain poetry to my otherwise business-like reporting.

But speaking with a number of biosimilar makers, I’ve come to the conclusion that industry and media need a larger thesaurus to avoid misrepresenting and undermining these biological drugs.

Perjorative and innacurate

Merck & Co. spokesman Robert Consalvo told us “terms such as copycats, knock-offs or generics are not accurate in describing biosimilars and only serve to add confusion and misunderstanding of an important new pathway for expanding access to medicines.”

His firm “recognises that there may be some questions, and some confusion about what biosimilars are, what they are not, how they get approved, and how they differ from originator biologics​,” he continued, adding that this drove the creation of its new online resource Biosimilars Clarified.

Meanwhile fellow pharma firm Pfenex said the terms ‘knock-off’ and ‘copycat’ were “pejorative”​ and imply that somehow these products are inferior to their reference biologics.

“[This] could not be further from reality,”​ CEO Bert Liang told us. “Inherently, a biosimilar is a biologic – a drug produced from a living organism rather than based on synthetic chemicals, therefore, these products are very complex and should be studied very carefully.”

Bio-reciprocal?

Sandoz’s Chris Lewis agreed, adding such terminology is “unhelpful for physicians and patients as they absolutely do not reflect the complex science and considerable investments of time and money that are made in getting high-quality biosimilars to the patients who need them.”

However, while Merck and Pfenex are happy that the term ‘biosimilar’ itself accurately reflects the extensive scientific studies undertaken to show the product’s equivalence, Sandoz has certain reservations.

“The term ‘biosimilar’ can indeed be unhelpful in broadening understanding of these complex medicines, and while ‘biosimilar medicine’ is the recognized regulatory term, EMA regulators have themselves stressed that the term should not be misunderstood,”​ Lewis said.

Quoting Christian Schneider, Chairman Biosimilar Working Party, Lewis added: “’Like the reference medicine, the biosimilar has a degree of natural variability. When approved, its variability and any differences between it and its reference medicine will have been shown not to affect safety or effectiveness.’

“All manufacturers should strive to bring this level of clarity to the definitions instead of using terminology to differentiate.”

So what do you think? Is there a term or phrase to describe these products that you would like to see across these pages? Let us know in the comments box below.

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1 comment

Nomenclature is Needed Too

Posted by Ronald A. Rader,

Nomenclature is also needed. The much and still debated U.S. proper or official names are useful only for what they are designed for – broad names names for product marketing and designating prescriptions, and are useless otherwise (including being totally undefined). Along these lines, if you look, you will see that FDA has recently, apparently due to naming insecurity (and related ignorance and avoidance), simply stopped identifying biopharmaceutical active agents/drug substances in public documents, including product inserts and approvals-related documentation. For example, neither FDA nor Sandoz/Novartis nor major trade associations have even responded to my inquiries requesting they identify the active agent/drug substance in Zarxio (filgrastim-sndz). Is it filgrastim-sndz (No, that's the proper/official US name for the marketed product); filgrastim, the INN (generic name for the drug substance) used in most every other country worldwide (but such a generic name can’t be used to identify specific products); or N-L-methionyl-granulocyte-colony stimulating factor, r-metHuG-CSF, or other more descriptive or science-based name? Related to this and many other biopharmaceutical nomenclature issues (including no nomenclature systems at all for biopharmaceuticals), I have a pending Citizen Petition at FDA requesting FDA assign (or just unofficially use) both unique/distinct and biosimilar/(bio)generic names (or other identifiers) for both finished biologic products and active agents/drug substances; and disclosure of nomenclature and basic CMC-related information that define these drug substances and products, including pre-approval release of this names and defining information and its discussion at advisory committee meetings. See www.biopharmacopeia.com.

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