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

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

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.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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Marty Duvall, Oncopeptides CEO

On­copep­tides stock craters as it pulls can­cer drug Pepax­to from the mar­ket

Shares of Oncopeptides crashed more than 70% in early Friday trading after the company said it’s pulling its multiple myeloma drug Pepaxto (melphalan flufenamide) from the US market after failing a confirmatory trial. The move will force the company to close its US and EU business units and enact significant layoffs.

The FDA had scheduled an adcomm meeting next Thursday to discuss Pepaxto, which first won accelerated approval in February and costs about $19,000 per course of treatment. The committee was to weigh in on whether the confirmatory trial demonstrated a worse overall survival in the treatment arm compared to the control arm.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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Pfiz­er pitch­es its Covid-19 vac­cine for younger chil­dren ahead of ad­comm next week

Pfizer will present its case to the FDA’s vaccine adcomm next week, seeking authorization for a lower-dose version of its Covid-19 vaccine for kids ages 5 through 12, which the Biden administration said will likely begin rolling out early next month.

Two primary doses of the 10 µg vaccine (the dose for those ages 12 and up is 30 μg) given 3 weeks apart in this group of children “have shown a favorable safety and tolerability profile, robust immune responses against all variants of concern including Delta, and vaccine efficacy of 90.7% against laboratory-confirmed symptomatic COVID-19,” the company said in briefing documents ahead of next Tuesday’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

Jay Flatley, new Zymergen CEO

Fol­low­ing Au­gust melt­down, Zymer­gen hints at sal­vage plans — cut­ting jobs and rene­go­ti­at­ing loans

Two months after a spectacular implosion that saw its founding CEO leave his post amid customer reports its only product didn’t work, Zymergen provided the first peek behind the curtain for its plans moving forward.

In an SEC filing Wednesday, Zymergen told regulators it would slash about 100 jobs and had renegotiated a $100 million loan from Perceptive that loomed like a storm cloud over the company, moving up the maturity date 18 months to June 30, 2022. Jed Dean, one of Zymergen’s three co-founders and VP of operations, will also step down at the end of the month.

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