Roche and My­lan set­tle a scrap over Her­ceptin, clear­ing path to a glob­al launch of a knock­off drug

Heather Bresch, CEO of My­lan

Two weeks ago Roche shares jumped on the news that the phar­ma gi­ant had scored win­ning Phase III da­ta sup­port­ing the com­bi­na­tion of Her­ceptin and Per­je­ta in fight­ing ear­ly-stage breast can­cer. And to­day, Roche and My­lan are an­nounc­ing that they’ve agreed to a set­tle­ment of their long-run­ning dis­pute over a biosim­i­lar of Her­ceptin, leav­ing My­lan with boast­ing rights for its shot at be­com­ing the first com­pa­ny to get a knock­off on­to the US mar­ket.

My­lan and Roche ham­mered out a glob­al li­cens­ing pact that gives My­lan launch dates for mar­kets around the world. But the com­pa­nies are keep­ing the sched­ule un­der wraps. As part of the set­tle­ment, My­lan is drop­ping a le­gal chal­lenge to two of Genen­tech’s patents.

From the state­ment:

Fol­low­ing this set­tle­ment and the re­cent ac­cep­tance of My­lan’s ap­pli­ca­tion for its pro­posed biosim­i­lar trastuzum­ab with the U.S. Food and Drug Ad­min­is­tra­tion (FDA), My­lan an­tic­i­pates po­ten­tial­ly be­ing the first com­pa­ny to launch a biosim­i­lar to Her­ceptin in the US.

My­lan is fac­ing a Sep­tem­ber 3rd PDU­FA date on their knock­off of Her­ceptin, a megablock­buster for Roche that brought in $6.7 bil­lion last year. The com­pa­ny has man­aged to stall com­peti­tors to its big fran­chise drug, though, giv­ing it time to ma­neu­ver for­ward with a com­bo suc­ces­sor that should help keep it high­ly com­pet­i­tive. Just a week ago Roche lost a three-year run­ning fight with My­lan and Bio­con over its at­tempt to break in­to the key In­di­an mar­ket.

Roche’s Dan O’Day said ear­li­er that he didn’t be­lieve a biosim­i­lar of Her­ceptin would reach the US mar­ket be­fore the fall of this year.

Roche’s po­si­tion now will lean heav­i­ly on da­ta from its APHIN­I­TY study, which demon­strat­ed pos­i­tive da­ta for the com­bi­na­tion of Per­je­ta and Her­ceptin in post-surgery pa­tients.

Am­gen and No­var­tis, mean­while, have been spar­ring over the rules on in­tro­duc­ing new biosim­i­lars. Leg­is­la­tion re­quires a 180-day no­tice of sales be­fore biosim­i­lar mar­ket­ing can start, and No­var­tis wants to sup­ply the no­tice ahead of a for­mal ap­proval to al­low for a quick start. Am­gen and op­po­nents, though, ar­gue that the no­tice should be on­ly al­lowed af­ter an ap­proval, in or­der to avoid mar­ket “chaos.” And both sides are tak­ing the case, which in­cludes a dis­pute over re­quir­ing biosim­i­lars man­u­fac­tur­ers to dis­close ap­pli­ca­tions, to the Supreme Court next month.

The set­tle­ment is big news for My­lan, which de­vel­oped the biosim­i­lar with In­dia’s Bio­con. My­lan has sole mar­ket­ing con­trol in the US, Cana­da, Japan, Aus­tralia, New Zealand and in the Eu­ro­pean Union and Eu­ro­pean Free Trade As­so­ci­a­tion coun­tries, with Bio­con hold­ing co-sales rights in the rest of the world.

My­lan CEO Heather Bresch com­ment­ed:

There is an un­met need for ac­cess to more af­ford­able ver­sions of bi­o­log­ic prod­ucts such as trastuzum­ab. We look for­ward to en­hanc­ing ac­cess to this im­por­tant treat­ment op­tion, which com­ple­ments our com­pre­hen­sive can­cer care of­fer­ings, in the U.S. and around the world. With 16 biosim­i­lar prod­ucts in de­vel­op­ment, we be­lieve My­lan has one of the in­dus­try’s broad­est port­fo­lios of biosim­i­lars and that we will be a leader in bring­ing high-qual­i­ty biosim­i­lar prod­ucts to mar­ket giv­en our abil­i­ty not on­ly to de­vel­op and man­u­fac­ture such com­plex prod­ucts, but al­so to nav­i­gate the in­tri­cate reg­u­la­to­ry and le­gal en­vi­ron­ment and suc­cess­ful­ly com­mer­cial­ize these prod­ucts on a glob­al ba­sis.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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Sanofi and Re­gen­eron clear the fin­ish line in an in­flam­ma­to­ry esoph­a­gus dis­ease, leav­ing Take­da in the dust

With atopic dermatitis rivals breathing down Dupixent’s neck, Sanofi and Regeneron on Friday secured a first win in new territory in what Sanofi’s head of immunology and inflammation Naimish Patel called the fastest approval he’s ever seen.

The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.

Fu­ji­film con­tin­ues its biotech build­ing spree with new fa­cil­i­ty in Chi­na

A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.

Fujifilm Irvine Scientific has opened its new Innovation and Collaboration Center in Suzhou New District, China, an area in Jiangsu province specifically designated for technological and industrial development.

According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.

Rob Etherington, Clene CEO

Mary­land of­fers loan to Clene de­spite ALS tri­al bumps

Even after Utah-based Clene failed to hit its primary endpoints for its ALS drug last year, the state of Maryland is putting its money at least behind Clene’s manufacturing facility.

The Maryland Board of Public Works has finalized a $3 million, 60-month loan facility with Clene Nanomedicine. The loan was provided by the state’s Neighborhood BusinessWorks program within the Maryland Department of Housing and Community Development.

Armon Sharei, SQZ founder and CEO

SQZ's out­side-the-box man­u­fac­tur­ing method slash­es pro­duc­tion time in ear­ly in study

At ASCO 2021 in June of last year, SQZ Biotech showcased a glimpse of its unorthodox cell therapy manufacturing tech. And on Wednesday, the Watertown, MA, company announced that its first-generation system showed comparable or better performance than a conventional clean-room-based manufacturing process.

The study was non-clinical. Clinical trials are expected by the first half of 2023.

SQZ’s device opens up a temporary window by cell-squeezing to deliver cargoes into cells. Its average processing time was less than six hours per batch, which is more than half the time than conventional methods. The company is planning to use the technology in its first red blood cell derived program for celiac disease. That IND is set to be submitted in the first half of 2023, the company said.

Bobby Sheng, Bora Pharmaceuticals CEO

With new ac­qui­si­tion, Bo­ra to ven­ture in­to bi­o­log­ics

Last week, Taiwan-based CDMO Bora Pharmaceuticals announced that it acquired Eden Biologics. Now, it says that purchase has helped established Bora Biologics, expanding into the biopharmaceutical market.

The acquisition of the company’s assets, which are located in the Hsinchu Biomedical Science Park in Taiwan, is helping Bora build its presence in the biopharma world by expanding production capacity of cell lines for the production of protein drugs. It will also improve the quality control and inspection specifications, as well as cell bank generation. The facility has four 500-liter bioreactors that have been approved by European and Taiwanese regulators.

Paul Chaplin, Bavarian Nordic president and CEO

With mon­key­pox cas­es ris­ing, one Eu­ro­pean coun­try is lock­ing down a small­pox vac­cine con­tract

As the global number of confirmed and suspected monkeypox cases continues to slowly climb, one country is trying to get a head start on potential vaccine stocking.

Bavarian Nordic signed a contract with an undisclosed European nation to supply its smallpox vaccine in response to new cases this month, the company announced Thursday morning. The continent saw its first monkeypox case confirmed about two weeks ago, with both the UK and Portugal seeing cases, according to the Washington Post.

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