FDA re­vers­es course, de­cides not to add suf­fix­es to old­er bi­o­log­ics’ non­pro­pri­etary names

The FDA has de­cid­ed not to go back and re­name bi­o­log­ics’ non­pro­pri­etary names with non­sense suf­fix­es, as it once said it would, rais­ing ques­tions about the con­fu­sion that will like­ly come from a sub­set of bi­o­log­ics’ and biosim­i­lars’ names con­tain­ing suf­fix­es while an­oth­er sub­set of bi­o­log­ics’ names will not con­tain suf­fix­es.

Since 2015, the FDA has been adding the mean­ing­less suf­fix­es to biosim­i­lars’ non­pro­pri­etary names as part of an ef­fort to im­prove phar­ma­covig­i­lance. And since No­vem­ber 2017, the agency al­so be­gan adding the suf­fix­es to new­ly ap­proved bi­o­log­ics’ names, with the in­ten­tion of go­ing back and adding suf­fix­es to all bi­o­log­ics’ non­pro­pri­etary names.

Cur­rent­ly, all 17 ap­proved biosim­i­lars have been ap­proved with the four-let­ter suf­fix­es, as have the prop­er names of 27 orig­i­na­tor bi­o­log­ics.

Scott Got­tlieb

But now, ac­cord­ing to draft guid­ance re­leased Thurs­day, the FDA says that the non­pro­pri­etary names of pre­vi­ous­ly ap­proved prod­ucts “need not be re­vised in or­der to ac­com­plish the ob­jec­tives of the nam­ing con­ven­tion.” The FDA in Jan­u­ary 2017 pub­lished its fi­nal guid­ance on how the suf­fix­es would be added.

The ob­jec­tives from that plan — “phar­ma­covig­i­lance and safe use” — can be ac­com­plished, the FDA says, by ap­ply­ing the nam­ing con­ven­tion to bi­o­log­i­cal prod­ucts “at the time they are li­censed” and “with­out ap­ply­ing it to li­censed bi­o­log­i­cal prod­ucts that do not con­tain a suf­fix in their prop­er names.”

So why is the FDA de­cid­ing not to go back and re­name bi­o­log­ics with the suf­fix­es?

“This ap­proach is in­tend­ed to min­i­mize the po­ten­tial bur­den for spon­sors and the health­care sys­tems, and to avoid po­ten­tial con­fu­sion for health­care providers and pa­tients, giv­en that the non­pro­pri­etary names of drugs sel­dom change postap­proval,” the draft guid­ance says.

But the guid­ance will al­so mean that all biosim­i­lars will have ran­dom non­sense suf­fix­es, while their ref­er­ence prod­ucts will not have the suf­fix­es — po­ten­tial­ly rais­ing ques­tions about whether the prod­ucts are sim­i­lar.

The Biosim­i­lars Fo­rum said in a state­ment that the FDA’s “de­ci­sion aban­dons the ret­ro­spec­tive ad­di­tion of a suf­fix to orig­i­na­tion bi­o­log­ics, lead­ing to an un­sub­stan­ti­at­ed no­tion that strict phar­ma­covig­i­lance is on­ly es­sen­tial for biosim­i­lars.”

FDA Com­mis­sion­er Scott Got­tlieb said in a state­ment: “We ex­pect that as time goes on, and more bi­o­log­i­cal prod­ucts are in­tro­duced to the mar­ket with dis­tin­guish­able suf­fix­es, pa­tients and providers in­creas­ing­ly will un­der­stand that the suf­fix­es re­flect a con­sis­tent nam­ing con­ven­tion and are not an in­di­ca­tor of prod­uct qual­i­ty.”

And for in­ter­change­able prod­ucts, the draft guid­ance says unique suf­fix­es will be used to “fa­cil­i­tate man­u­fac­tur­er-spe­cif­ic phar­ma­covig­i­lance.”

“An ap­pli­cant for a pro­posed in­ter­change­able prod­uct sub­mit­ted un­der sec­tion 351(k) of the PHS Act should pro­pose a suf­fix com­posed of four low­er­case let­ters for use as the dis­tin­guish­ing iden­ti­fi­er in­clud­ed in the prop­er name des­ig­nat­ed by FDA at the time of li­cen­sure. Such sub­mis­sions can be made dur­ing the in­ves­ti­ga­tion­al new drug ap­pli­ca­tion (IND) phase or at the time of BLA sub­mis­sion. An ap­pli­cant should sub­mit up to 10 pro­posed suf­fix­es, as de­scribed in the Nam­ing Guid­ance, in the or­der of the ap­pli­cant’s pref­er­ence,” the draft says.

But the FDA al­so says that it “does not in­tend to ap­ply the nam­ing con­ven­tion de­scribed in the Nam­ing Guid­ance to tran­si­tion bi­o­log­i­cal prod­ucts.”

Sim­i­lar­ly, the FDA is “re­con­sid­er­ing whether vac­cines should be with­in the scope of the nam­ing con­ven­tion.” Sanofi wrote to the FDA last month ex­plain­ing how the ad­di­tion of suf­fix­es to vac­cine la­bels could cause con­fu­sion among health care providers and neg­a­tive­ly im­pact pub­lic health.

“In view of the ex­ist­ing frame­work for en­sur­ing safe­ty re­port­ing and mon­i­tor­ing for vac­cines, the agency is care­ful­ly con­sid­er­ing whether the in­for­ma­tion that’s al­ready avail­able to us through iden­ti­fi­ca­tion sys­tems as­so­ci­at­ed with the ad­min­is­tra­tion of vac­cines is suf­fi­cient­ly ro­bust for en­sur­ing phar­ma­covig­i­lance such that we may not need dis­tin­guish­able prop­er names with suf­fix­es for vac­cines,” Got­tlieb added.

The FDA’s use of the non­sense suf­fix­es is al­so unique in that no oth­er coun­try in the world has em­ployed their use. Cana­da re­cent­ly de­cid­ed to not use suf­fix­es in the non-pro­pri­etary names of bi­o­log­ics or biosim­i­lars.

Read more: Pro­ce­dures for Han­dling Re­quests for Non­pro­pri­etary Name Suf­fix Re­view for Bi­o­log­i­cal Prod­ucts New­ly Li­censed Un­der Sec­tion 351of the PHS Act​

First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion.

Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,400+ biopharma pros reading Endpoints daily — and it's free.

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,400+ biopharma pros reading Endpoints daily — and it's free.

The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,400+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis jumps in­to Covid-19 vac­cine hunt, as Big Phar­ma and big biotech com­mit to bil­lions of dos­es

After spending most of the pandemic on the sidelines, Novartis is offering its aid in the race to develop a Covid-19 vaccine.

AveXis, the Swiss pharma’s gene therapy subsidiary, has agreed to manufacture the vaccine being developed by Massachusetts Eye and Ear and Massachusetts General Hospital. The biotech will begin manufacturing this month, while the vaccine undergoes further preclinical testing. They’ve agreed to provide the vaccine for free for clinical trials beginning in the second half of 2020, but have not disclosed financials for after.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,400+ biopharma pros reading Endpoints daily — and it's free.

Bris­tol My­ers Squibb fi­nal­ly gets in the front­line NSCLC game dom­i­nat­ed by Mer­ck, adding a sec­ond Op­di­vo/Yer­voy-based op­tion

Bristol Myers Squibb may be trailing Merck and Roche in the checkpoint race to treat frontline cases of non-small cell lung cancer, but as it does, it makes sure to bring its best feet forward.

Just days after scoring a landmark NSCLC approval for Opdivo and Yervoy alone for PD-L1 positive patients, the company said the FDA has also OK’d using the two agents with a limited course of chemo regardless of the biomarker status.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,400+ biopharma pros reading Endpoints daily — and it's free.

Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.

Stymied by the pan­dem­ic, Im­munomedic­s' new CEO bows out, tak­ing a mil­lion bucks plus perks as he heads out the vir­tu­al ex­it

Just a little more than a month since taking over as the latest CEO to helm Immunomedics, $IMMU Harout Semerjian is exiting the company after being confronted by “logistical” obstacles thrown up by the pandemic that made it impossible for him to move from London to carry out the job. And he’s getting a little over a million dollars in cash plus perks to grease the skids on the way out.

Word of the changeup arrived right after the market closed Wednesday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,400+ biopharma pros reading Endpoints daily — and it's free.

Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,400+ biopharma pros reading Endpoints daily — and it's free.