Sen­a­tors seek changes to FDA guid­ance to speed en­try of in­sulin biosim­i­lars

As Eli Lil­ly an­nounced Mon­day that it would in­tro­duce an au­tho­rized gener­ic ver­sion of its Hu­ma­log in­sulin at half the orig­i­nal price, four sen­a­tors on both sides of the aisle are seek­ing tweaks to re­cent FDA guid­ance to speed up the mar­ket­ing of new biosim­i­lar in­sulin prod­ucts.

The guid­ance is part of FDA’s work to be­gin, start­ing in March 2020, tran­si­tion­ing ap­proved mar­ket­ing ap­pli­ca­tions for a sub­set of prod­ucts, in­clud­ing in­sulin and hu­man growth hor­mone — pre­vi­ous­ly ap­proved as drugs un­der sec­tion 505 of the FD&C Act — to be bi­o­log­ics.

But ques­tions re­main on whether this tran­si­tion pe­ri­od will briefly halt com­pa­nies from seek­ing to bring in­sulin com­pe­ti­tion to mar­ket.

Sens. Dick Durbin (D-IL), Kevin Cramer (R-ND), Tina Smith (D-MN) and Bill Cas­sidy (R-LA) wrote in a let­ter sent Fri­day to FDA Com­mis­sion­er Scott Got­tlieb that al­though this FDA guid­ance will fa­cil­i­tate the sub­mis­sion of biosim­i­lar in­sulin prod­ucts for the first time, “the cur­rent reg­u­la­to­ry frame­work still in­tro­duces per­verse in­cen­tives that could de­lay the in­tro­duc­tion of low-cost in­sulin prod­ucts in­to the mar­ket in the short-term, when they are need­ed most.”

“Our first con­cern is that ap­proved in­sulin ‘fol­low-ons’ un­der the FD&C will not tran­si­tion to biosim­i­lar li­cens­es, mean­ing they can­not be sub­sti­tut­ed for brand name ver­sions by phar­ma­cists,” they wrote.

They al­so take is­sue, as sev­er­al oth­ers have, with the fact that com­pa­nies with fol­low-on in­sulin ap­pli­ca­tions pend­ing or ten­ta­tive­ly ap­proved on 23 March 2020 will be re­ject­ed by FDA and have to be re-sub­mit­ted by the com­pa­nies.

“If FDA has the abil­i­ty to of­fer flex­i­bil­i­ty in one do­main, rec­og­niz­ing the cum­ber­some re­quire­ment to with­draw and re-sub­mit an ap­pli­ca­tion, then FDA should of­fer sim­i­lar flex­i­bil­i­ty for pend­ing and/or ten­ta­tive­ly ap­proved” in­sulin ap­pli­ca­tions, the sen­a­tors write. “No po­ten­tial ap­pli­cant who is oth­er­wise pre­pared to file to­day would sen­si­bly do so in the face of the loom­ing March 23, 2020 cut-off date—such ap­pli­cants would in­stead wait over a year un­til they would sub­mit un­der the biosim­i­lar ap­pli­ca­tion path­way.”

The sen­a­tors al­so seek ex­pla­na­tions from FDA, by 15 March, on three is­sues: “(1) the steps FDA is tak­ing the ex­pe­dite the ap­proval of in­sulin fol­low-on ap­pli­ca­tions pri­or to the March 23, 2020 dead­line, (2) how many ap­pli­ca­tions are cur­rent­ly pend­ing, and (3) whether FDA an­tic­i­pates ap­prov­ing any in­sulin fol­low-on ap­pli­ca­tions pri­or to the March 23, 2020 dead­line.”

In clos­ing, the sen­a­tors said they “re­main con­cerned the Agency’s 2018 guid­ance has flaws in the con­text of in­sulin prod­ucts that must be quick­ly reme­died.”

The let­ter comes as both the House and Sen­ate’s fo­cus on the price of in­sulin has in­ten­si­fied re­cent­ly.

Late last month, the Sen­ate Fi­nance Com­mit­tee be­gan a bi­par­ti­san in­ves­ti­ga­tion in­to in­sulin prices. That move fol­lowed sim­i­lar ques­tions from the House Com­mit­tee on En­er­gy and Com­merce in Jan­u­ary seek­ing more in­for­ma­tion on the root caus­es of the ris­ing cost of in­sulin from the three US in­sulin man­u­fac­tur­ers: Eli Lil­ly, No­vo Nordisk and Sanofi.

In ad­di­tion, Rep. Pe­ter Welch (D-VT) re­cent­ly in­tro­duced a bill to al­low for the im­por­ta­tion of in­sulin from Cana­da, and lat­er on as FDA sees fit, oth­er sim­i­lar coun­tries.

Let­ter to Got­tlieb

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.

Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,100+ biopharma pros reading Endpoints daily — and it's free.

As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,100+ biopharma pros reading Endpoints daily — and it's free.

Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.