Cell­tri­on re­ceives CRLs for Rit­ux­an, Her­ceptin biosim­i­lars

Cell­tri­on has re­ceived com­plete re­sponse let­ters (CRLs) from the FDA for two bi­o­log­ics li­cense ap­pli­ca­tions for rit­ux­imab and trastuzum­ab biosim­i­lars, a Cell­tri­on spokesman told Fo­cus on Thurs­day.

The CRLs fol­low an FDA warn­ing let­ter is­sued to Cell­tri­on in Jan­u­ary, which the spokesman said “was di­rect­ly re­lat­ed to the re­ceipt of the CRL. Cell­tri­on is mak­ing progress ad­dress­ing these con­cerns and is com­mit­ted to work­ing with the agency to ful­ly re­solve all out­stand­ing is­sues with the high­est pri­or­i­ty and ur­gency.”

The BLAs were sub­mit­ted in June 2017 for the pro­posed biosim­i­lar to Rit­ux­an (rit­ux­imab) and in Au­gust 2017 for a biosim­i­lar to Her­ceptin (trastuzum­ab).

The warn­ing let­ter fol­lowed an in­spec­tion of Cell­tri­on’s In­cheon, South Ko­rea-based man­u­fac­tur­ing site in May and June 2017 that re­sult­ed in a Form 483. FDA al­so re­cent­ly re­leased the 59-page, par­tial­ly redact­ed Es­tab­lish­ment In­spec­tion Re­port.

Ac­cord­ing to the warn­ing let­ter, FDA ob­served “mul­ti­ple poor asep­tic prac­tices” dur­ing the set­up and fill­ing of a batch of ster­ile drug prod­uct. The site man­u­fac­tures mul­ti­ple bi­o­log­ics.

In the EU, the Eu­ro­pean Med­i­cines Agency’s Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use last De­cem­ber is­sued a pos­i­tive opin­ion rec­om­mend­ing that Herzu­ma, the biosim­i­lar for trastuzum­ab, be grant­ed mar­ket­ing au­tho­riza­tion in the EU. Cell­tri­on’s biosim­i­lar for rit­ux­imab was ap­proved by the Eu­ro­pean Com­mis­sion in Feb­ru­ary 2017 and has launched in the UK, Ger­many, Nether­lands, Spain and Ko­rea.

An­oth­er Hu­mi­ra biosim­i­lar com­ing to EU in 2018

Mean­while, Ab­b­Vie and Bio­gen an­nounced ear­ly Thurs­day that they have set­tled lit­i­ga­tion and Bio­gen and Sam­sung Bioepis’ Hu­mi­ra (adal­i­mum­ab) biosim­i­lar, known as Im­ral­di, will come to mar­ket in the EU on 16 Oc­to­ber 2018.

Hu­mi­ra is cur­rent­ly the top sell­ing drug in the world, and two oth­er com­peti­tors from Boehringer In­gel­heim and Am­gen have al­so won au­tho­riza­tion in the EU.

Am­gen’s Hu­mi­ra biosim­i­lar is ex­pect­ed to come to mar­ket at the same date as Im­ral­di in the EU, while in the US, Am­gen and Ab­b­Vie set­tled on 31 Jan­u­ary 2023 for a launch. Sam­sung, how­ev­er, said in the US, if ap­proved, its Hu­mi­ra biosim­i­lar will launch on 30 June 2023.


First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion. Im­age: A Cell­tri­on man­u­fac­tur­ing fa­cil­i­ty. CELL­TRI­ON

Author

Zachary Brennan

managing editor, RAPS

In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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UP­DAT­ED: Have a new drug that promis­es to fight Covid-19? The FDA promis­es fast ac­tion but some de­vel­op­ers aren't hap­py

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

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The race to de­vel­op Covid-19 drugs and vac­cines is on — here’s what’s hap­pen­ing in the UK

Weeks away from the results of ongoing US and China trials testing its experimental antiviral remdesivir, Gilead is going to trial the failed Ebola drug in a small group of coronavirus patients in England and Scotland. The United Kingdom is also home to a range of other therapeutic efforts, as the pandemic rages on across the globe.

On Tuesday, Southampton, UK-based startup Synairgen kicked off a mid-stage placebo-controlled study testing its experimental drug, SNG001 — an inhaled formulation of interferon-beta-1a — that has previously shown to be safe and effective in improving lung function in asthma patients with a respiratory viral infection in a pair of Phase II trials.

‘There was a grow­ing weari­ness’: Rush­ing against a pan­dem­ic clock, As­pen Neu­ro­sciences se­cures $70M Se­ries A

Just before Christmastime, Howard Federoff got a tip from Washington: There was a new virus in China. And this one could be bad.

News report of the virus had not yet appeared. Federoff, a neuroscientist, was briefed because years before, he was vetted as part of a group — he didn’t give a name for the group — to consult for the US government on emerging scientific issues. His day job, though, was CEO of Aspen Neurosciences, a Parkinson’s cell therapy startup that days before had come out of stealth mode and gave word to investors they were hoping to raise $70 million. That, Federoff realized, would be difficult if a pandemic shut down the global economy.

FDA puts pe­di­atric aGVHD drug on pri­or­i­ty re­view lane — will they go vir­tu­al with the ad­comm?

Despite worries about regulatory delays due to new work arrangements under Covid-19, the FDA appears intent to go full speed ahead with its everyday work, not only granting priority review to a stem cell therapy for acute graft versus host disease but also plotting an advisory committee meeting for it.

With a PDUFA date of September 30, the journey of the drug — remestemcel-L, or Ryoncil — could shed light on the agency’s capacity to facilitate drug development unrelated to Covid-19.

Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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Covid-19 roundup: Trump push­es his new fa­vorite, untest­ed drug; CRISPR out­lines crip­pling im­pact of Covid-19

President Trump has a new favorite Covid-19 drug.

After a conversation with Japanese Prime Minister Shinzo Abe, Politico reports, the president is pressuring the FDA to issue emergency use authorization for favipiravir, a flu drug that showed glimpses of success in China but remains unproven and carries a list of worrying side effects. The push comes after a week-plus in which the White House touted a potentially effective but unproven malaria medication despite the concerns of scientific advisors such as NIAID director Anthony Fauci. And Trump ally Rudy Giuliani has been talking up unproven cell therapy efforts on Twitter.

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ITeos nabs $125M as they prep Keytru­da com­bi­na­tion tri­al — if Covid-19 will let them

For iTeos, it turned out, $75 million could only last so long.

Two years after announcing their eye-catching Series B raise, the Belgian biotech is back with an even larger Series B-2: $125 million.

The now $175 million financing – $25 million of the first B round is considered part of the second – illustrates the vast capital available for those with promising new immuno-oncology compounds, particularly those that might be used in combination with existing therapies. In December, iTeos announced a collaboration with Merck to test its lead compound with Keytruda this year. The proceeds will push forward that trial and help fund the ongoing Phase I/II trials for that compound, EOS-850, and a second one, EOS-448.

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