From The Editor | January 4, 2019

Biosimilar "Fake Views" Roundup

anna rose welch author page

By Anna Rose Welch, Editor, Biosimilar Development

biosimilar industry

Over the past few years, I’ve been envious of the editorial fun other publications have in the weeks leading up to the new year. For example, given my background in poetry, I was sad to realize that STAT beat me to the “turn-life-sciences-into-poetry” punch with its end-of-year limerick round-up. But as we enter the new year, I decided to have a little bit of fun myself. The “news” excerpts below are all works of fiction written by yours truly (with some help from a secret partner-in-crime). But the end goal of this creative biosimilar-related exercise is to reflect upon and make light of the most prominent market hurdles we’ve faced thus far in the biosimilar industry. Enjoy, and I wish you (and all your biosimilars) a happy, healthy, and prosperous 2019!


FDA Revisits Biologics Naming Protocol Following Industry Criticism

After several years of contentious debate amongst members of the pharmaceutical industry and stakeholder groups, in a historic moment, the FDA has announced it is reversing its course on biologic and biosimilar naming. While biologics and biosimilars were formerly required to add a four-letter, non-meaningful suffix to their non-proprietary names, the FDA has proposed a drastic revision: the introduction of emoji-suffixes.

“One of the most common concerns we heard from stakeholders has been that the non-meaningful suffixes are too difficult to remember,” said a senior member of the FDA’s Center for Drug Evaluation and Research (CDER). “We have taken the industry’s comments to heart and have reconsidered the appropriate naming convention to maximize the success of biosimilar products and interchangeable products. We hope that, by changing the suffixes from non-meaningful letters to a series of emojis, stakeholders will better be able to identify each product and improve reporting accuracy — which can now be done by text messaging,” they added.   

In 2017, the FDA finalized its Nonproprietary Naming of Biological Products, which specified that novel biologics and their biosimilar counterparts be given a four-letter non-meaningful suffix to aid in adverse event reporting and to ensure long-term safety and efficacy — for instance, infliximab-dyyb or adalimumab-atto. Now, under the new policy, the FDA has sent out a call to manufacturers with products already approved and available on the market to send in 10 emoji-suffix options. In its draft guidance, the FDA has requested that manufacturers select a series of emojis that best tell the product’s story.

For example, as one reputable industry consultant described in an interview with this publication, this new naming policy provides manufacturers with a chance to invoke the positive impact biologics can have on patients’ lives.

“I highly anticipate the use of emojis that suggest a renewed sense of youthful vitality — for example, the comet, the flying money, the Xbox controller, or the weightlifter,” they offered. “Companies may even choose to embrace the flag emojis to be transparent about where each product is manufactured. The possibilities are seemingly endless.”    

The FDA has also included a list of emojis that would best be stricken from any suffix considerations, as they may unintentionally invoke negative physician and patient bias against these products. Examples of banned emojis include: anything resembling a devil’s head, the puking face, the skull and cross-bones, all representations of snakes and dragons, the crying cat, and the saxophone.  

Similarly, in instances where products have been provided a prefix, for example Tbo-filgrastim, the FDA has asked for industry feedback on several specific proposals, including bringing in an unbiased audience to assist in the naming process. One possible angle the agency is seeking industry commentary on is employing Starbuck’s baristas, many of whom have had ample experience with creative naming exercises.

“We’re looking forward to receiving the industry’s comments on this new draft guidance, and we hope that giving manufacturers the opportunity to tell their product’s story through a meaningful emoji suffix will foster a seamless and memorable prescribing and treatment experience for physicians and patients,” said an FDA spokesperson.


New RECREATE Act To Address Pharma REMS Abuse

For years, the generics and biosimilars industries have called for legislation addressing Risk Evaluation and Mitigation Strategies (REMS) abuse, a critical hurdle in the efficient development of cost-effective alternative treatments. Today, the industry’s pleas may finally be answered, thanks to a newly proposed bipartisan bill introduced by the newly formed House Pharmaceutical Industry Issues Committee (PIIC). Known as the RECREATE Act, this legislation takes a page from the formerly proposed CREATES Act, which has yet to be signed into law since its introduction in 2017.

As many in the pharmaceutical industry have testified, a handful of brand companies have argued that their FDA-required REMS program or their company-implemented risk management program stipulate they are unable to provide their products for safety reasons. Much like the CREATES Act, the RECREATE Act aims to ensure the timely development of small molecule generics and biosimilars by providing a process through which these companies can ascertain originator product lots for the necessary analytical testing. However, as the name of the RECREATE Act suggests, there will be a new “recreational” method through which generics and biosimilar companies can attain these originator samples.

The bill outlines a competitive process in which a case of the much-needed originator drug will be placed at a private, remote location (biologics-temperature-appropriate). Neither the innovator nor the biosimilar/generics company will be apprised of the location. Through innovative thinking and by solving a well-crafted set of clues, members of each company — which will be known as biotrackers — will team up to solve the mystery and ascertain the geographic coordinates of the originator samples. Whichever company finds the samples will be permitted to keep it. (Should it not be claimed by the generic/biosimilar maker, they either may choose to eliminate the development of the product from their pipeline, or they may file an injunction to receive the samples, in keeping with the formerly proposed CREATES Act.)  

“We’ve found the pharmaceutical industry is at its best when there is an element of competition in place,” one senator involved in drafting the legislation shared. “This new legislation was crafted to permit originator companies the opportunity to embrace and further showcase the innovation upon which the core of their company’s identity rests. This also gives biosimilar companies the chance to prove just how prepared they are to take on the challenging commercial risks they will no doubt be facing in the global market. And, we also think it just will be plain fun.”

In the few hours since the bill’s release, several pharmaceutical industry trade groups have expressed their immediate praise and support for the senators’ efforts, as well as their interest in providing commentary on the proposed law. In fact, several members of one of the biosimilar-specific trade groups have jumped at the opportunity to participate in a pilot for this proposed process.

Earlier today, members of the PIIC confirmed with this publication they have begun the drafting process for a series of riddles that will both entertain and seamlessly guide companies toward a future of greater market competition. Riddles for this pilot are expected to be completed and released to involved parties as soon as 2025.  


PBM’s New App Allows Formulary Management Professionals “To Swipe Right”

As the U.S. strives to reduce healthcare costs, one leading pharmacy benefit manager (PBM) has announced the launch of an innovative new tool that promises to rapidly decrease pharmaceutical-payer contract negotiation periods and formulary committee decisions. In a press release, the PBM introduced its new, proprietary app Tender®, specifically geared toward busy formulary management committee professionals and manufacturers.

In this day and age in which calls for lower prices and quicker competition are increasing in volume, payers are chomping at the bit to make the American healthcare system great again by bringing the U.S. on par with the successful healthcare savings seen in Europe. To do this, PBMs need a more transparent, less tedious method of making formulary decisions and forming partnerships with pharmaceutical manufacturers.

Tender® exists to clarify manufacturer and payer expectations up-front. As the U.S. biosimilar industry gains its footing, a key issue standing in the way of success is the misalignment of market expectations amongst different stakeholders. As one pharmaceutical industry trade group executive told us, “If biosimilar companies got a nickel for every time they’ve heard a payer say it was expecting higher discounts or larger rebates, we’d already be seeing a return-on-investment for our biosimilar portfolios.”

But what if these pricing misconceptions are simply telling us that not all biosimilar manufacturers and payers are an appropriate contracting match?

A VP at the company and the inventor of the Tender® app emphasized the importance of having choices in the U.S. healthcare system. “Manufacturers and payers can now strike up relationships with those healthcare partners who best match their long-term business and market access goals,” he explained. “Thanks to Tender®, each manufacturer and payer can begin the tenuous, often daunting task of treatment negotiations from the comfort and honesty of their own couches.”

A standard manufacturer Tender® profile will feature several types of information, including: A picture of the product’s primary packaging; the non-proprietary name of its drug, along with any brand names it goes by in the real world (including a pronunciation guide); a brief description of the drug’s clinical and pharmacoecomic data; and the manufacturer’s proposed price, discount, and rebate offering.

A standard payer’s profile will consist of their current formulary status (including which drugs it currently favors); a list of their partnership qualifications and expectations; and their expected pricing ranges for specific products.

With an easy, single swipe left for “unviable partnership offer” or a swipe right for “proposition of interest” payers and manufacturers can easily be matched with the most suitable partners. Following a mutual match, potential partners can start a dialogue using the app’s chat function prior to meeting officially in the boardroom. The chat function can also be used to share similar hobbies and movie preferences.

“We are excited to offer a valuable new solution for our employees, pharmaceutical partners, and our plan members,” a company spokesperson told shareholders today at a press conference. “Tender® will guarantee a more transparent contracting process for payers and manufacturers, in turn providing the treatments patients need today in a timely and affordable fashion.”


USPTO Modernizes Patent Extension Process With New Gameshow Format

Pharmaceutical giant AbbVie announced Tuesday that it has won a whopping eight more years of U.S. market exclusivity for its leading product, extending its current exclusivity period from 2023 to 2031. This new market exclusivity period became possible thanks to a recently passed law outlining modern and more transparent methods for granting patent extensions to innovative treatments currently on the market.

In the past, patent extensions were typically granted following a particularly complex review and approval process by the U.S. Patent and Trademark Office. “There were just so many hard forms we had to fill out — we always worried the patent would run our before we even finished filing for it,” one legal expert from the pharmaceutical industry shared in an email.

However, in the past few years, thanks to healthcare industry stakeholder commentary calling for “fewer legal terms that sound like witchcraft” and “more laws real people can read,” pharmaceutical companies have been afforded a new, more general-populace-friendly method of patenting.

AbbVie, in particular, owes its recent win to its performance last night on the newly formed Biopardy, a gameshow closely resembling that of Jeopardy created specifically for pharmaceutical industry executive competitors.

In keeping with Jeopardy’s format, Biopardy features three contestants — all of which are members of a pharmaceutical company’s executive leadership team. Each contestant provides answers (in the form of questions) from one of six different categories over the course of three rounds. However, instead of earning a specific dollar amount for each correct answer, the player answering each question correctly is awarded a certain number of months of additional U.S. market exclusivity, ranging anywhere from one to six additional months. These patent-terms can also be doubled via the “daily biosimilar” or increased during Final Biopardy. Big winners are invited back to the tournament of Patent Champions.

In keeping with the scientific and business knowledge of pharma executive leadership, categories of questions last night included, “Draw that molecule,” “Provide the non-meaningful suffix,” “Famous lab explosions,” and “Tender-breaking.”  

The innovator clinched its big win, however, during the Final Biopardy round, which required participants to properly spell 8 out of 10 brand names correctly. The winning executive spelled all but one right (forgetting the critical h in Cyloterexsyivhyalta), successfully doubling its bet of 48-months of additional patent protection.

The company’s Chief Patent Officer shared the good news with shareholders at a live-streamed company update early this morning. “We are thrilled to have been given the opportunity to extend the patent life our lead product, which, over the past 75 years, has demonstrated its immense value for patients,” he said. “We look forward to reappearing as the reigning champion on Biopardy to attain more much-needed market exclusivity to ensure patients continue to receive this critical treatment until 2050, or even later.”