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

UP­DAT­ED: In a stun­ning turn­around, Bio­gen says that ad­u­canum­ab does work for Alzheimer's — but da­ta min­ing in­cites plen­ty of ques­tions

Biogen has confounded the biotech world one more time.

In a stunning about-face, the company says that a new analysis of an old dataset on aducanumab has restored its faith in the drug as a game-changer for Alzheimer’s and, after talking it over the FDA, they’ll now be filing for an approval of a drug that had been given up for dead.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,700+ biopharma pros reading Endpoints daily — and it's free.

Bris­tol-My­ers makes Op­di­vo pitch for front­line lung can­cer with open la­bel PhI­II study

Despite a head start, when Bristol-Myers Squibb and its pioneering checkpoint inhibitor Opdivo suffered a key lung cancer setback in 2016, they found themselves relegated to the backseat as Merck’s Keytruda seized the wheel on the road to immunotherapy stardom. Bristol-Myers has since suffered blow after blow in its quest to take a big slice of the lucrative market, peppered with some small successes. On Tuesday, the New Jersey drugmaker touted positive data from a Phase III open-label study in a bid to carve itself a piece of the frontline lung cancer market.

UP­DAT­ED: Clay Sie­gall’s $614M wa­ger on tu­ca­tinib pays off with solid­ly pos­i­tive piv­otal da­ta and a date with the FDA

Back at the beginning of 2018, Clay Siegall snagged a cancer drug called tucatinib with a $614 million cash deal to buy Cascadian. It paid off today with a solid set of mid-stage data for HER2 positive breast cancer that will in turn serve as the pivotal win Siegall needs to seek an accelerated approval in the push for a new triplet therapy.

And if all the cards keep falling in its favor, they’ll move from 1 drug on the market to 3 in 2020, which is shaping up as a landmark year as Seattle Genetics prepares for its 23rd anniversary on July 15.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,700+ biopharma pros reading Endpoints daily — and it's free.

Vas Narasimhan. Getty Images

Failed PhI­II fe­vip­iprant tri­als pour more cold wa­ter on No­var­tis' block­buster R&D en­gine — and spread the chill to a high-pro­file biotech

Back in July, during an investor call where Novartis execs ran through an upbeat assessment of their Q2 performance, CEO Vas Narasimhan and development chief John Tsai were pressed to predict which of the two looming Phase III readouts — involving cardio drug Entresto and asthma therapy fevipiprant, respectively — had a higher likelihood of success. Tsai gave the PARAGON-HF study with Entresto minimally better odds, but Narasimhan emphasized that their strategy of giving fevipiprant to more severe patients gave them confidence.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,700+ biopharma pros reading Endpoints daily — and it's free.

Take­da tees up $420M deal for celi­ac an­ti­dote, con­tin­u­ing R&D re­fo­cus

Sometime in the 1st century AD, a patient presented to Arataeus looking like a varicose ghost. He was “emaciated and atrophied, pale, feeble and incapable of performing any of his accustomed works,” the Greek physician wrote, with hollow temples and huge veins running all over his body.

A dysfunctional digestive system, Arataeus concluded – an imbalance he attributed to a “heat” deficiency in a system he and other Greeks regarded as functioning similarly to an oven – and coined a term: coeliac disease, after the Greek word for abdomen.

UP­DAT­ED: The FDA sets a reg­u­la­to­ry speed record, pro­vid­ing a snap OK for Ver­tex's break­through triplet for cys­tic fi­bro­sis

The FDA has approved Vertex’s new triplet for cystic fibrosis at a record-setting speed.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,700+ biopharma pros reading Endpoints daily — and it's free.

IM­brave150: Roche’s reg­u­la­to­ry crew plans a glob­al roll­out of Tecen­triq com­bo for liv­er can­cer as PhI­II scores a hit

Just weeks after Bristol-Myers Squibb defended its failed pivotal study pitting Opdivo against Nexavar in liver cancer, Roche says it’s beat the frontline challenge with a combination of their PD-L1 Tecentriq with Avastin. And now they’re rolling their regulatory teams in the US, Europe and China in search of a new approval — badly needed to boost a trailing franchise effort.
Given their breakthrough and Big Pharma status as well as the use of two approved drugs, FDA approval may well prove to be something of a formality. And the Chinese have been clear that they want new drugs for liver cancer, where lethal disease rates are particularly high.
Researchers at their big biotech sub, Genentech, say that the combo beat Bayer’s Nexavar on both progression-free survival as well as overall survival — the first advance in this field in more than a decade. We won’t get the breakdown in months of life gained, but it’s a big win for Roche, which has lagged far, far behind Keytruda and Opdivo, the dominant PD-1s that have captured the bulk of the checkpoint market so far.
Researchers recruited hepatocellular carcinoma — the most common form of liver cancer — patients for the IMbrave150 study who weren’t eligible for surgery ahead of any systemic treatment of the disease.
Roche has a fairly low bar to beat, with modest survival benefit for Nexavar, approved for this indication 12 years ago. But they also plan to offer a combo therapy that could have significantly less toxicity, offering patients a much easier treatment regimen.
Cowen’s Steven Scala recently sized up the importance of IMbrave150, noting:

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,700+ biopharma pros reading Endpoints daily — and it's free.

That $335M JV Bay­er set up on CRISPR/Cas9? They’re let­ting the biotech part­ner car­ry on

Bayer committed $300 million to set up a joint venture on CRISPR/Cas9 tech with CRISPR Therapeutics $CRSP. But they’re handing off control now to the smaller biotech while retaining a couple of opt-ins for programs nearing an IND.

Bayer $BAY made much of the fact that they were going all-in on gene editing when they did their deal 3 years ago with CRISPR Therapeutics, which pitched $35 million in on their end. This was the cornerstone of their plan to set up new JVs that could make some serious leap forwards in hot new R&D spaces. Now CRISPR will have full management control of Casebia as they pursue programs in hemophilia, ophthalmology and autoimmune diseases.
Samarth Kulkarni, the CEO at CRISPR, made it sound like a natural progression.

J&J's block­buster Ste­lara wins US ap­proval for ul­cer­a­tive col­i­tis

J&J’s Stelara, which is set to be in the top ten list of blockbusters come 2025, is now cleared by the FDA for use in ulcerative colitis (UC), an inflammatory disease of the large intestine.

The biologic targets interleukin (IL)-12 and IL-23 cytokines, which are known to play a key role in inflammatory and immune responses. Stelara, which generated about $4.7 billion in the first nine months of 2019, is a key player in the crowded marketplace of drugs to treat autoimmune disorders such as psoriasis, rheumatoid arthritis and Crohn’s disease. AbbVie’s star therapy, Humira, continues to dominate, despite its looming patent cliff in the United States, while others including J&J’s $JNJ own anti-IL23 Tremfya, Lilly’s $LLY anti-IL-17 Taltz and AbbVie’s $ABBV recently approved anti-IL-23 antibody Skyrizi carve out a slice of market share.