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.”

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,400+ biopharma pros reading Endpoints daily — and it's free.

An Endpoints Zoom meeting; and the email header employees will see if your company is a Premium subscriber

What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Michelle McMurry-Heath, BIO CEO (BIO via YouTube)

BIO looks to re­struc­ture, lay­ing off staff amid chal­lenge to the trade org's nor­mal face-to-face style

The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. But for BIO, the industry’s leading trade organization, the pandemic has prompted a reconsideration of the game plan.

BIO will pivot to digital as the Covid-19 pandemic continues to rage, making “some staff reductions” as it looks to bring its roughly 37,000 in-person meetings each year to the web, the organization said Thursday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,400+ biopharma pros reading Endpoints daily — and it's free.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,400+ biopharma pros reading Endpoints daily — and it's free.

Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,400+ biopharma pros reading Endpoints daily — and it's free.

Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Fast on Glax­o­SmithK­line's heels, Au­rinia wins OK to steer a sec­ond lu­pus nephri­tis drug straight to the mar­ket

GlaxoSmithKline’s Benlysta isn’t alone in the small circle of approved lupus nephritis drugs anymore.

Little Aurinia Pharmaceuticals has gotten the green light from the FDA to start marketing its first and only program, voclosporin, under the brand name Lupkynis — something CEO Peter Greenleaf says it’s been ready to do since December.

Regulators went right down to the wire on the decision, keeping the company and the entire salesforce it’s already assembled on its toes.