FDA com­mish cheers on biosim­i­lars as Am­gen, Al­ler­gan score OK for knock­off of Roche's Avastin

Roche now has an­oth­er big biosim­i­lar ri­val to con­tend with.

Scott Got­tlieb

The FDA has OK’d Mvasi, a knock­off of a drug that earned $3 bil­lion in the US — $7 bil­lion world­wide — last year as a main­stay in Roche’s drug port­fo­lio. Am­gen and Al­ler­gan — which wound up with mar­ket­ing rights af­ter it emerged on top af­ter a se­ries of merg­ers over the last 5 years — can now start lin­ing up a launch, as the big com­pa­nies scrap over the patents that ex­pire in 2018 and 2019.

The big col­lab­o­ra­tors al­so re­cent­ly filed for an FDA OK for a biosim­i­lar of Roche’s Her­ceptin.

In what is now stan­dard op­er­at­ing pro­ce­dure at the FDA, reg­u­la­tors hand­ed out their ap­proval for most of the full string of la­bel in­di­ca­tions Roche won in the US. And there are plen­ty more ap­pli­ca­tions for oth­er Avastin biosim­i­lars in the in­dus­try pipeline, as these new biosim­i­lar plays clus­ter around the big fran­chise ther­a­pies on the mar­ket.

No­var­tis, mean­while, snagged a Eu­ro­pean OK for its copy of Roche’s Rit­ux­an in June, fol­low­ing Cell­tri­on’s win on the same front.

The ap­proval fol­lows a unan­i­mous pan­el rec­om­men­da­tion in Mvasi’s fa­vor, as well as a high-lev­el en­dorse­ment from the agency to ush­er these copy­cats in­to the mar­ket as soon as pos­si­ble. The grow­ing flank at­tack on its big drugs al­so un­der­scores the re­cent rash of set­backs that Roche has had to con­tend with, as a string of late-stage ef­forts have run in­to se­ri­ous trou­ble at ex­act­ly the wrong mo­ment for Roche.

“Bring­ing new biosim­i­lars to pa­tients, es­pe­cial­ly for dis­eases where the cost of ex­ist­ing treat­ments can be high, is an im­por­tant way to help spur com­pe­ti­tion that can low­er health­care costs and in­crease ac­cess to im­por­tant ther­a­pies,” said FDA com­mis­sion­er Scott Got­tlieb in a state­ment “We’ll con­tin­ue to work hard to en­sure that biosim­i­lar med­ica­tions are brought to the mar­ket quick­ly, through a process that makes cer­tain that these new med­i­cines meet the FDA’s rig­or­ous gold stan­dard for safe­ty and ef­fec­tive­ness.”

Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.

Pfiz­er, Bris­tol My­ers dom­i­nate top 10 pre­dic­tions for the best-sell­ing drugs of 2022

The annual exercise where analysts try and predict which drugs will become blockbusters and make the most money tends to highlight the biggest trends in biopharma R&D. 2022 is no exception.

The team at Evaluate Vantage published its predictions for the top 10 selling drugs for the year — expecting tens of billions of dollars in sales and highlighting an industry-wide focus on certain diseases and indications.

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Nabiha Saklayen, Cellino co-founder and CEO (via Cellino)

Backed by Bay­er's Leaps, Boston-based Celli­no lands $80M for cell ther­a­py-in-box

The summer before Cellino CEO and co-founder Nabiha Saklayen started at Harvard, she lost her grandmother following complications to diabetes. Before then, she hadn’t taken a biology class since ninth or tenth grade — the mark of a classic physicist — but it was then she decided she wanted the rest to sit at the intersection of the two for the rest of her career

Combine that with being across the way from the University’s stem cell institute in Cambridge, and you get the birth of Cellino, an autonomous cell therapy manufacturing company that just announced the closing of its Series A.