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

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

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.

Covid-19 roundup: J&J be­gins piv­otal Phase III tri­al for vac­cine; Sanofi and GSK reach deal with Cana­da for 72 mil­lion vac­cine dos­es

Johnson & Johnson announced it’s beginning a pivotal Phase III trial for its Covid-19 candidate, JNJ-78436735 — the first single-dose vaccine in this stage.

The Phase III trial, dubbed ENSEMBLE, will enroll 60,000 patients worldwide, making it the largest Phase III study of a Covid-19 vaccine to date. J&J said the candidate achieved positive interim results in a Phase I/IIa study, which will be published “imminently.” There’s a possibility that the first batches will be ready for potential emergency use in early 2021, according to the biotech.

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FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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Patrick Enright, Longitude co-founder (Longitude)

As its biotechs hit the pan­dem­ic ex­it, Lon­gi­tude rais­es $585M for new neu­ro, can­cer, ag­ing and or­phan-fo­cused fund

The years have been kind to Longitude Capital. This year, too.

A 2006 spinout of Pequot Capital, its founders started their new firm just four years before the parent company would go under amid insider trading allegations. Their first life sciences fund raised $325 million amid the financial crisis, they added a second for $385 million and then in, 2016, a third for $525 million. In the last few months, the pandemic biotech IPO boom netted several high-value exits from those funds, as Checkmate, Vaxcyte, Inozyme and Poseida all went public.

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Scoop: ARCH’s Bob Nelsen is back­ing an mR­NA up­start that promis­es to up­end the en­tire man­u­fac­tur­ing side of the glob­al busi­ness

For the past 2 years, serial entrepreneur Igor Khandros relied on a small network of friends and close insiders to supply the first millions he needed to fund a secretive project to master a new approach to manufacturing mRNA therapies.

Right now, he says, he has a working “GMP-in-a-box” prototype for a new company he’s building — after launching 3 public companies — which plans to spread this contained, precise manufacturing tech around the world with a set of partners. He’s raised $60 million, recruited some prominent experts. And not coincidentally, he’s going semi-public with this just as a small group of pioneers appears to be on the threshold of ushering in the world’s first mRNA vaccines to fight a worldwide pandemic.

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Isaac Veinbergs, Libra CEO

With $29M in Se­ries A, Boehringer-backed Li­bra looks to tack­le neu­rode­gen­er­a­tion through cel­lu­lar clean­ing

Can the natural process by which cells clean out toxic proteins be harnessed to create potential treatments for neurodegenerative disorders?

That’s the question Libra Therapeutics will be trying to answer, as the new biotech officially launched Wednesday morning with $29 million in Series A financing. The company has three preclinical programs at the ready, with its lead candidate targeting ALS and frontotemporal dementia. But CEO Isaac Veinbergs said he hopes to develop therapies for a wide range of diseases, including Parkinson’s, Alzheimer’s and Huntington’s.

Gene Wang, Immetas co-founder and CEO (file photo)

Im­metas Ther­a­peu­tics nabs $11M Se­ries A to nar­row their bis­pe­cif­ic work tar­get­ing in­flam­ma­tion in age-re­lat­ed dis­eases

How does a biotech celebrate its two-year anniversary? For Immetas Therapeutics, it’s with an $11 million Series A round and a game plan to fight age-related disease.

Co-founders Gene Wang and David Sinclair came together years ago around the idea that inflammation is the ultimate process driving age-related illnesses, including cancer. The duo launched Immetas in 2018 and packed the staff with industry experts. Wang, who says he’s always had an entrepreneurial spirit, has held lead roles at Novartis, GSK, Bristol Myers Squibb and Merck. He’s worked on blockbuster drugs like Humira, Gardasil, Varubi and Zolinza. And now, he’s channeling that spirit as CEO.