FDA of­fers No­var­tis a thumbs-up on En­brel biosim­i­lar as Am­gen plays of­fense/de­fense si­mul­ta­ne­ous­ly

On Fri­day, the FDA gave Am­gen a clean bill of health for its biosim­i­lar of Ab­b­Vie’s Hu­mi­ra. To­day, it’s Am­gen’s turn to watch a megablock­buster go un­der the biosim­i­lar gun, as the FDA of­fers a clear thumbs up to No­var­tis’ knock­off of the $9 bil­lion drug En­brel.

Two days ahead of a pan­el re­view, FDA in­sid­ers said that No­var­tis’ gener­ics di­vi­sion San­doz had of­fered all the da­ta need­ed to con­clude that the copy­cat was good for all in­di­ca­tions Am­gen sells En­brel for in the U.S. The FDA’s in­sid­er con­clu­sion:

“In con­sid­er­ing the to­tal­i­ty of the ev­i­dence, the da­ta sub­mit­ted by San­doz show that GP2015 is high­ly sim­i­lar to US-li­censed En­brel, notwith­stand­ing mi­nor dif­fer­ences in clin­i­cal­ly in­ac­tive com­po­nents, and that there are no clin­i­cal­ly mean­ing­ful dif­fer­ences be­tween GP2015 and US-li­censed En­brel in terms of the safe­ty, pu­ri­ty, and po­ten­cy of the prod­uct to sup­port the demon­stra­tion that GP2015 is biosim­i­lar to the US-li­censed En­brel in the stud­ied in­di­ca­tion of PsO. The Ap­pli­cant has al­so pro­vid­ed an ex­ten­sive da­ta pack­age to ad­dress the sci­en­tif­ic con­sid­er­a­tions for ex­trap­o­la­tion of da­ta to sup­port biosim­i­lar­i­ty to oth­er con­di­tions of use and po­ten­tial li­cen­sure of GP2015 for each of the in­di­ca­tions for which US-li­censed En­brel is cur­rent­ly li­censed and for which GP2015 is el­i­gi­ble for li­cen­sure.”

The de­ci­sion, which is like­ly to pave the way to a quick ap­proval, is a mir­ror re­flec­tion of the FDA’s view of Am­gen’s Hu­mi­ra biosim­i­lar, which threat­ens Ab­b­Vie’s $14 bil­lion fran­chise. But where Am­gen is fight­ing to get its biosim­i­lar on the mar­ket, it’s fight­ing tooth and nail against No­var­tis, wag­ing a le­gal war against No­var­tis’ de­vel­op­ment strat­e­gy, which stud­ied the drug on­ly for pso­ri­a­sis but is look­ing for an ap­proval on a full slate of in­di­ca­tions.

In this case, the FDA doesn’t have a prob­lem with in­di­ca­tion ex­trap­o­la­tion, as it is called, but de­pend­ing whether you’re play­ing of­fense or de­fense, it’s a flash point on the le­gal front.

These back-to-back biosim­i­lar ap­pli­ca­tions mark a new stage in the field. No­var­tis won a pi­o­neer­ing ap­proval for the first biosim­i­lar with Zarxio, a knock­off of fil­gras­tim, and has its eyes on Hu­mi­ra and oth­er ag­ing block­busters. The agency clear­ly has its doors open to these big play­ers who are threat­en­ing to top­ple some of the most lu­cra­tive drug fran­chis­es in the world. And the first wave of ap­pli­ca­tions are blaz­ing a trail for oth­ers to fol­low. But in the end, the near-term prospects for the field may be lim­it­ed if the com­pa­nies play­ing de­fense can pre­vail in the courts and pro­tect their patents for years to come.

The ju­ry is still out on that, but the FDA is mak­ing its po­si­tion crys­tal clear.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

An­gion's or­gan dam­age drug strikes out again, this time in high-risk kid­ney trans­plant pa­tients

After flopping a test in Covid-19 earlier this year, Angion’s lead organ damage drug has now hit the skids again in kidney transplant patients.

Angion and partner Vifor Pharma’s ANG-3777 failed to beat out placebo in terms of improving eGFR, a measure of kidney function, in patients who had received a deceased donor kidney transplant and were at high risk of developing what is known as delayed graft function, according to Phase III results released Tuesday.

An image of Alzheimer's brain tissue. The red show gingipains, a protein from P. gingivalis, intermixing with neurons (yellow) and glial cells (green)

An Alzheimer's dark­horse fails its first big tri­al, but of­fers hope for a long-over­looked hy­poth­e­sis

Three years ago, Cortexyme emerged out of obscurity with some big-name backers and an unorthodox approach to treating Alzheimer’s.

They moved their drug into a pivotal study the next year, offering one of the first major tests for a hypothesis that has fluttered on the outskirts of Alzheimer’s research for decades: that, in many cases, the disease is driven by infectious agents — the havoc they wreak in the brain and the inflammation the body uses to try to fend them off. And that quashing the infection could slow patients’ cognitive decline.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.