What Biosimilars Can Learn From The Diamond Industry

By Anna Rose Welch, Editorial & Community Director, Advancing RNA

A few weeks ago, I was vacationing on the Outer Banks in Duck, NC. I spent the week whipping through novels and non-biosimilar-related news stories while listening to the ocean (often punctuated by my mother’s raving about the grace of pelicans). It was during one of my many reading sessions that I stumbled upon a Racked feature about lab-grown diamonds. Not only are there some fascinating parallels between the fledging biosimilar and lab-grown diamond industries, but there are also some lessons biosimilar makers can take away from the development and commercialization of lab-grown diamonds.

A Short History Of Lab-Grown Diamonds

The diamond industry, as we know it today, flourished following the launch of De Beers mining company in 1888. But, surprisingly, lab-created diamonds came to light a century earlier. In the late 1700s, the French chemist Antoine Lavoisier discovered that diamonds were simply crystallized carbon. For the next 200 years, researchers set out to grow diamonds in a lab setting. Little progress was made until 1954, when General Electric (GE) succeeded in creating small, brown, synthetic diamonds. As these gemstones lacked the clarity of mined diamonds, they were put to industrial use until GE created the first jewelry-worthy stones in 1971. 

As is the case for most industries earning their footing, GE’s process was not commercially feasible as it required a “colossal” amount of energy and financial resources to accomplish. However, technology has since become better, faster, and cheaper (familiar words to pharma). As such, diamond labs have continued springing up in the U.S., India, and China. In 2012, Genesis Diamond Company became the first to succeed in creating a colorless and very valuable type IIa diamond in the lab. (Only 2 percent of mined diamonds attain this qualification.) To the naked eye — and even to experts without the aid of spectroscopy — these lab-created gems are identical in structure and appearance. They also cost 20 to 30 percent less than mined diamonds.

Regardless of these qualities, lab-grown diamonds still have not quite caught on. These stones account for less than 1 percent of the overall diamond industry. And public perception is clearly one of the roadblocks to industry growth. To lab-growers’ chagrin, lab-grown diamonds are referred to as “synthetic” in the jewelry industry. Because of this, lab-grown diamonds are often perceived as knockoffs or “cheaters” like cubic zirconia and moissanite, which are chemically different from diamonds altogether.

How Are Biosimilars “Similar” To Lab-Grown Diamonds?

Biosimilars are (contentiously) referred to as “knockoffs” and “copy-cats” in the media. “Bathtub biosimilars” is one of the more horrifying terms of endearment I’ve stumbled upon. And at least one physician statement I’ve read compared biosimilars to snake oil. Obviously, biosimilars are not “identical” to the originator molecule in the way a lab-grown diamond is to a mined diamond. And perhaps it’s callous to compare a piece of jewelry to a life-saving biologic therapy. But there is something to be said of the parallel of the skepticism in both the diamond and pharma industries about these cost-effective, alternative products.

How Diamonds (And Biosimilars) Can Garner Trust

For biosimilars, any problems with safety or efficacy at this point in the game could lead to a loss of physician and patient trust. The diamond industry also requires consumer trust to succeed. How the diamond industry has chosen to embrace this challenge seems relevant to the biosimilar industry, as well. A few months ago, several lab-grown diamond companies teamed up to create the International Grown Diamond Association (IGDA). Like the biosimilar interest groups that have sprung up lately in the pharma industry, the IGDA aims to educate the public and promote honesty within the diamond industry. As the secretary general of the IGDA told Racked, “We felt it was important for people in the market to be fully transparent, to promote their material as truly lab-grown, and to be differentiated from the mined diamonds.” For instance, instead of classifying the exact color of a lab-grown diamond, as would be done for a mined diamond, these gems are classified by a category range (e.g., D-F, G-J). This ensures that lab-made diamonds are not sold as natural diamonds; in turn, hopefully bolstering consumer trust and product transparency.

In the past few months, the FDA has determined that biosimilar international non-proprietary names (INNs) will have unique, meaningless (for now) suffixes. Similarly, while biosimilar labels won’t include comparative data (as per the draft guidance), there must be a statement of biosimilarity. Following these draft guidances, biosimilar makers expressed concern over the fact that biosimilars are being differentiated from their reference products. After all, to reach the market, analytical and clinical evidence proving similarity, safety, and efficacy was required. Many experts are worried the differences in naming and labeling will serve as a roadblock to market growth. I have often expressed the same concerns when looking at the growing success of biosimilars in the EU without the use of suffixes and differing labels. But having spoken with patient advocacy groups, and after reading this Racked feature, I’m starting to wonder if these differences will be as harmful as anticipated for biosimilars in the U.S., or if they could be a way to encourage uptake.  

Physicians and patients have been expressing their support for meaningful suffixes and other differentiations between the reference product and biosimilar. In the end, the success of biosimilars will depend on building trust with patients, physicians, and pharmacists. Though biosimilars have been proven safe and effective for years in the EU, the U.S. is intent on forging its own path — one which requires changes to biosimilar naming and labeling protocol. The analytical and clinical data will continue to speak for the similarity of a biosimilar to its reference product — both structurally and in terms of efficacy. But biosimilars, falling in the middle of the generic-innovator spectrum, are in a unique position. If we step back and think about the lab-grown diamond industry’s willingness to proclaim the differences between their gems and mined diamonds to build consumer trust, then perhaps this too will be the way biosimilar makers can begin to win over U.S. doctors and patients.