Roche $RHB­BY un­veiled a cheer­ful up­date on its per­for­mance in the first nine months of this year, with de­mand for its new­er drugs — pri­mar­i­ly in on­col­o­gy/im­munol­o­gy — dri­ving sales, par­tic­u­lar­ly in Chi­na where can­cer is on the rise. In its press re­lease, the Swiss drug­mak­er men­tioned its pend­ing $4.3 bil­lion ac­qui­si­tion of Spark Ther­a­peu­tics $ONCE, promis­ing the deal — which has seen de­lay af­ter de­lay due to un­re­lent­ing scruti­ny by com­pe­ti­tion reg­u­la­tors — will be con­sum­mat­ed by the end of the year.

The com­pa­ny — the world’s largest can­cer drug­mak­er — lift­ed its full-year sales fore­cast, spurred by a 12% jump to about $36.7 bil­lion in phar­ma­ceu­ti­cal sales. Sales were fu­eled by de­mand for Roche’s mul­ti­ple scle­ro­sis drug Ocre­vus, he­mo­phil­ia treat­ment Hem­li­bra, and its on­col­o­gy prod­ucts: check­point in­hibitor Tecen­triq and mon­o­clon­al an­ti­body Per­je­ta and old­er Avastin — which more than off­set de­clines in the sales of its can­cer drugs Her­ceptin and MabThera/Rit­ux­an.

Sales in Eu­rope were down 1% due to Her­ceptin (-44%) and MabThera/Rit­ux­an (-33%), but the strong growth of new­er treat­ments al­most stead­ied the ship.

Bill An­der­son Roche

“The im­pact of biosim­i­lars (in Eu­rope) is tail­ing off,” not­ed Roche’s head of phar­ma­ceu­ti­cals Bill An­der­son in a post-earn­ings con­fer­ence call on Wednes­day. Her­ceptin biosim­i­lars launched in Eu­rope about two years ago, while MabThera biosim­i­lar ero­sion in the re­gion kicked off last year.

Roche’s three lega­cy on­col­o­gy drugs — Rit­ux­an, Her­ceptin, and Avastin — are ripe for biosim­i­lar com­pe­ti­tion in the Unit­ed States — and ear­li­er this year the com­pa­ny saw the launch of the first Her­ceptin and Avastin biosim­i­lar. (Al­though if oth­er biosim­i­lar launch­es are any kind of barom­e­ter, the ero­sion of drug fran­chis­es in the Unit­ed States is fair­ly mut­ed com­pared to Eu­rope.)

Still, An­der­son preached cau­tion. “We do ex­pect there to be sig­nif­i­cant im­pact from biosim­i­lars in the US, be­cause there will be biosim­i­lars to all three of our lega­cy on­col­o­gy prod­ucts — but al­so be­cause there’s a need for ad­di­tion­al com­pe­ti­tion, and we’ve been ex­pect­ing it.”

He pre­dict­ed the first five biosim­i­lars for Rit­ux­an will come some­time over the next quar­ter, with at least a cou­ple of more Her­ceptin biosim­i­lars in the next six months, and an­oth­er Avastin biosim­i­lar at the end of the year and/or ear­ly 2020.

In­ter­na­tion­al sales grew a healthy 20% main­ly due to a strong up­take in Chi­na, where rates of can­cer are high due to pol­lu­tion and smok­ing. At some point the com­pa­ny will see lim­it­ed biosim­i­lar com­pe­ti­tion in Chi­na, al­though “there may be some ques­tions about the qual­i­ty of some of those ear­ly biosim­i­lars so I think will we see our­selves as able to com­pete,” An­der­son said. “In fact, one of the ways that will be com­pet­ing in Chi­na is get­ting drugs like Per­je­ta and Hem­li­bra added to the na­tion­al drug re­im­burse­ment list.”

As is the tra­di­tion, the com­pa­ny al­so culled a num­ber of ex­per­i­men­tal drugs across its pipeline:

Sev­erin Schwan Roche

One of the key cuts is pe­tesi­cat­ib (RG7625), which was be­ing de­vel­oped to treat celi­ac dis­ease and au­toim­mune dis­or­ders, in­clud­ing Sjö­gren’s syn­drome and pso­ri­a­sis. The oral com­pound was en­gi­neered to tar­get cathep­sin-S. Years ago, Mer­ck had tout­ed the com­mer­cial po­ten­tial of its cathep­sin-K in­hibitor for os­teo­poro­sis, al­though it was forced to ter­mi­nate the pro­gram af­ter it was linked to an in­creased risk of car­dio­vas­cu­lar events.

At the tail end of the con­fer­ence call, the ques­tion of the Spark ac­qui­si­tion fi­nal­ly cropped up. Roche chief Sev­erin Schwan did not go in­to specifics but re­it­er­at­ed that he was con­fi­dent the deal would be com­plet­ed by year-end.

So­cial im­age: Roche

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.