Pfiz­er launch­ing first US mAb biosim­i­lar with Rem­i­cade knock­off, but you can for­get about any fire sale

Diem Nguyen, Pfiz­er

Pfiz­er $PFE plans to launch the first mAb copy­cat and the sec­ond biosim­i­lar ever in the US in the next few weeks. But the price will look al­most as close to the orig­i­nal as the drug it­self, as Pfiz­er will on­ly cut 15% off the whole­sale price for this pi­o­neer­ing biosim­i­lar.

Dubbed In­flec­tra (in­flix­imab-dyyb), the ther­a­py is a xe­rox of Rem­i­cade, a main­stay bi­o­log­ic that has bol­stered J&J $JNJ for years. De­vel­oped by South Ko­rea’s Cell­tri­on, Pfiz­er bagged the US com­mer­cial­iza­tion rights with its ac­qui­si­tion of Hos­pi­ra, which part­nered with Cell­tri­on. And Cell­tri­on has been steadi­ly eat­ing in­to Mer­ck’s fran­chise rev­enue from Rem­i­cade af­ter be­gin­ning sales in Eu­rope last year.

The launch comes af­ter J&J had vowed to fight to the last at­tor­ney in their le­gal bat­tle to pro­tect the US Rem­i­cade fran­chise, but a judge ruled against the phar­ma gi­ant in Au­gust, clear­ing a path for Pfiz­er.

Pay­ers had been look­ing for ini­tial dis­counts of 15% to 30%, but it looks like they’ll have to wait un­til No­var­tis and oth­ers come along with their own ri­val biosim­i­lars to be­gin a price war. No­var­tis CEO Joe Jimenez has pre­dict­ed that the dis­counts will even­tu­al­ly reach 75%, though the mar­ket has a long way to go be­fore it reach­es the bar­gain base­ment.

Diem Nguyen, re­gion­al pres­i­dent North Amer­i­ca, Pfiz­er Es­sen­tial Health Busi­ness, said:

“By in­tro­duc­ing IN­FLEC­TRA to the U.S. mar­ket­place, Pfiz­er is help­ing cus­tomers ac­cess an ad­di­tion­al high qual­i­ty treat­ment op­tion that promis­es greater sav­ings for the health­care sys­tem. We are proud of our glob­al lead­er­ship in biosim­i­lars, and will con­tin­ue our ef­forts to ad­vance a sus­tain­able, com­pet­i­tive mar­ket­place for these ther­a­pies to de­liv­er a high qual­i­ty, con­sis­tent sup­ply of prod­uct and long-term sav­ings and val­ue for pa­tients and physi­cians.”

J&J, though, is hang­ing tough. Dur­ing the Q3 call on Tues­day, man­age­ment was dis­count­ing the dis­count­ed com­pe­ti­tion.

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

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Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.
Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

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FDA slaps a hold on an AML tri­al as Mark­er scraps a fail­ing ovar­i­an can­cer pro­gram, sink­ing shares

The FDA has placed a hold on a Phase II AML trial from the small immuno-oncology biotech Marker Therapeutics. Marker disclosed the issue two weeks after responding to FDA concerns, adding it to the Q3 release Tuesday. The company also announced it was scrapping a Phase II ovarian cancer program it determined was unlikely to succeed.

The agency’s concern centers around two reagents used in manufacturing for their trial for acute myeloid leukemia patients who have received a stem cell transplant. The reagents are from third parties and not present in the final product, Marker said.

Eli Lil­ly-backed biotech grabs $100M to dis­patch an­ti­body-oligonu­cleotide con­ju­gates af­ter mus­cu­lar dy­s­tro­phy

Hold up your hand. Make a fist. Now open it. And again.

If you can do it fully and with ease, then the proteins in your hand are likely working properly. If you can’t then they may not be. In people with myotonic muscular dystrophy, something more atomic is going on.

In those folks, the problem is RNA. Certain base pairs repeat far beyond normal, up to 11,000 superfluous letters in some cases. The extended strands form “clumps.” Proteins misform and can’t function properly. They often allow one movement but not the reverse, a condition called myotonia that gives the dystrophy its name.

As­traZeneca sets stage for mar­ket­ing ap­pli­ca­tion with promis­ing piv­otal lu­pus drug da­ta

After fumbling in its first late-stage lupus study, AstraZeneca disclosed that a second pivotal trial testing its experimental drug, anifrolumab, had met the main goal, in August. Earlier this week, the British drugmaker broke out the numbers from its successful study.

Last year, anifrolumab failed to meet the main goal of diminishing disease activity in the 460-patient TULIP I study, a 52-week trial that tested two doses of the drug versus a placebo. But in the 373-patient TULIP II study, the higher dose (300 mg) was compared to patients given a placebo — patients in both arms were on baseline standard care.

FDA Vas­cepa re­view spot­lights new safe­ty sig­nals, pos­si­ble min­er­al oil spoil­er as Amarin hunts a block­buster ap­proval

An in-house FDA review of Amarin’s Vascepa raises a set of hurdles the biotech will have to clear if the biotech expects to get the long-awaited FDA approval that could set it on a path to superstar status. But it appears that Amarin has survived another potential setback without introducing a major new threat to its prospects.

The stakes don’t get much higher, with analysts saying a win this week for Amarin could lead to billions in new sales — provided the agency stamps it with an OK. And investors liked what they say in the FDA review this morning, bumping the stock $AMRN 17%.

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FDA puts Sol­id Bio’s lead gene ther­a­py pro­gram on hold — again — af­ter an­oth­er pa­tient is hurt by SGT-001

Solid Biosciences continues to be plagued by safety issues.

Close to 18 months after the gene therapy biotech was able to quickly shed an FDA hold on their lead Duchenne muscular dystrophy program for SGT-001, regulators have stepped back in to force another halt after another patient was hit hard by a set of serious adverse events remarkably similar to the first set.

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