FDA (via Endpoints News)

FDA tar­gets faster re­views for biosim­i­lar sup­ple­ments, draft guid­ance says

The FDA  on Thurs­day pub­lished new draft guid­ance ex­plain­ing how it will speed its re­view of biosim­i­lar or in­ter­change­able ap­pli­ca­tion sup­ple­ments, which can be used to up­date the ini­tial biosim­i­lar ap­proval when it is for few­er than all the ref­er­ence prod­uct’s li­censed con­di­tions of use.

The 9-page draft de­tails how FDA can­not li­cense a biosim­i­lar or in­ter­change­able prod­uct for an in­di­ca­tion pro­tect­ed by or­phan-drug ex­clu­siv­i­ty or pe­di­atric ex­clu­siv­i­ty un­til the ex­pi­ra­tion of that ex­clu­siv­i­ty. Ap­pli­cants al­so may de­cide not to seek li­cen­sure of a pro­posed biosim­i­lar or pro­posed in­ter­change­able prod­uct for con­di­tions of use that are pro­tect­ed by a patent or for oth­er rea­sons.

For in­stance, when Pfiz­er’s In­flec­tra (in­flix­imab-dyyb) and Mer­ck’s Ren­flex­is (in­flix­imab-ab­da) were first ap­proved, FDA ap­proved them for all the same in­di­ca­tions as J&J’s Rem­i­cade (in­flix­imab), ex­cept pe­di­atric ul­cer­a­tive col­i­tis. This in­di­ca­tion was ex­clud­ed be­cause J&J at the time en­joyed an FDA-grant­ed pe­ri­od of or­phan ex­clu­siv­i­ty. Sim­i­lar­ly, when Am­gen won ap­proval for its Hu­mi­ra (adal­i­mum­ab) biosim­i­lar Am­je­vi­ta (adal­i­mum­ab-at­to), the com­pa­ny did not seek ap­proval for sev­er­al in­di­ca­tions be­cause of or­phan ex­clu­siv­i­ty.

But af­ter that ex­clu­siv­i­ty or patent ex­pires, an ap­pli­cant may de­cide to sub­mit a sup­ple­ment to the li­censed 351(k) bi­o­log­ics li­cense ap­pli­ca­tion (BLA) for the pre­vi­ous­ly pro­tect­ed in­di­ca­tion.

And al­though FDA com­mit­ted to re­view­ing and act­ing on orig­i­nal 351(k) BLA sup­ple­ments with clin­i­cal da­ta with­in 10 months of re­ceipt, the agency now says such sup­ple­ments will be re­viewed and act­ed up­on in a 6-month time­frame.

“As not­ed, the Bs­U­FA II Goals Let­ter de­scribes a 10-month goal date for orig­i­nal 351(k) BLA sup­ple­ments with clin­i­cal da­ta. How­ev­er, at this time, FDA be­lieves that a re­view time­frame of 6 months will gen­er­al­ly be ap­pro­pri­ate for a sup­ple­ment to a li­censed 351(k) BLA seek­ing li­cen­sure of the biosim­i­lar or in­ter­change­able prod­uct for an ad­di­tion­al con­di­tion of use that has been pre­vi­ous­ly li­censed for the ref­er­ence prod­uct, as­sum­ing the sup­ple­ment does not raise nov­el re­view is­sues,” the draft says.

If an ap­pli­cant does not want FDA to take ac­tion on a 351(k) BLA or sup­ple­ment be­fore a spec­i­fied date, the ap­pli­cant should re­quest that FDA re­frain from act­ing on the ap­pli­ca­tion, the draft adds.

To make such a re­quest, the draft says that an ap­pli­cant should in­clude the fol­low­ing lan­guage on the cov­er let­ter of their BLA or sup­ple­ment, in bold type­face and promi­nent­ly placed above the body of the cov­er let­ter:

351(k) BLA ac­tion tim­ing re­quest: [Ap­pli­cant Name] re­quests that FDA not take ac­tion on this [ap­pli­ca­tion/sup­ple­ment] be­fore [spec­i­fied date].

The draft al­so ex­plains how the pro­posed la­bel­ing for a biosim­i­lar will de­pend on whether the ap­pli­cant is seek­ing li­cen­sure for all (or few­er) of the con­di­tions of use li­censed for the ref­er­ence prod­uct. And an ap­pli­cant may sub­mit a jus­ti­fi­ca­tion as to why, in the ap­pli­cant’s view, the draft la­bel­ing meets the re­quire­ments for ap­proval, con­sid­er­ing the con­di­tions of use for which the ap­pli­cant is seek­ing li­cen­sure.

FDA al­so says that it rec­om­mends that an ap­pli­cant seek­ing li­cen­sure for a pro­posed in­ter­change­able prod­uct seek li­cen­sure for all of the ref­er­ence prod­uct’s li­censed con­di­tions of use when pos­si­ble.

RAPS: 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.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and fully exited just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.

Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.

As­traZeneca pub­lish­es Covid-19 vac­cine PhI­II pro­to­cols in lock­step with Mod­er­na and Pfiz­er. How are they dif­fer­ent?

Following in the steps of Moderna and Pfizer, the other two American drugmakers currently in Phase III trials for their Covid-19 vaccines, AstraZeneca posted its own study protocols over the weekend. The move is the latest in a series of rare peeks behind the curtain, as such blueprints are typically shared once such trials are completed.

“Given the unprecedented global impact of the Coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial. As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials. AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company said in a statement.

Sebastian Nijman (file photo)

Roche looks to ge­net­ic mod­i­fiers for new drug tar­gets, team­ing up with Dutch biotech in $375M deal

Roche is gambling on a new way of discovering drug targets and, ultimately, promising to infuse more than $375 million into a small biotech if all goes well.

A spinout of the Netherlands Cancer Institute and Oxford University, Scenic Biotech set out to pioneer a field that’s gaining some traction among top VCs in the US: to harness the natural protecting powers of genetic modifiers — specific genes that suppress a disease phenotype.

Eli Lilly CSO Dan Skovronsky (file photo)

UP­DAT­ED: #ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.

Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.

#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.