EMA takes a stand against in­ter­change­abil­i­ty, says all ap­proved biosim­i­lars are in­ter­change­able

When Ab­b­Vie’s block­buster rheuma­toid arthri­tis drug fi­nal­ly sees some com­pe­ti­tion in the US in 2023, there’s like­ly to be a split field, with some biosim­i­lars, and some in­ter­change­able biosim­i­lars. The added des­ig­na­tion al­lows phar­ma­cists to switch the ref­er­ence prod­uct for the in­ter­change­able with­out a pre­scriber’s con­sent.

And while the US and Eu­ro­pean drug reg­u­la­tors typ­i­cal­ly agree on just about every­thing (with some ex­cep­tions), when it comes to this con­cept of biosim­i­lar in­ter­change­abil­i­ty, the Eu­ro­pean Med­i­cines Agency made clear in a state­ment yes­ter­day that all biosim­i­lars ap­proved in the EU are in­ter­change­able with their ref­er­ence prod­uct or with an equiv­a­lent biosim­i­lar.

The EMA said it’s mak­ing its stance known “be­cause the ab­sence of a clear EU-wide po­si­tion on in­ter­change­abil­i­ty has been iden­ti­fied as a fac­tor caus­ing un­cer­tain­ty among stake­hold­ers on the use of biosim­i­lars in clin­i­cal prac­tice,” point­ing to a study pub­lished last year that said, “many pre­scribers still have doubts on the safe­ty and in­ter­change­abil­i­ty of biosim­i­lars, es­pe­cial­ly mon­o­clon­al an­ti­bod­ies (mAbs) and fu­sion pro­teins.”

EMA said it con­sid­ers a clear EU-wide po­si­tion on in­ter­change­abil­i­ty nec­es­sary “to re­duce any un­cer­tain­ty that pre­scribers may have when de­cid­ing to pre­scribe bi­o­log­i­cal med­i­cines.”

But the an­nounce­ment should come as no sur­prise giv­en the fact that sev­er­al heads of Eu­ro­pean reg­u­la­tors in 2017 spelled out this same stance:

Our con­clu­sion is that a switch be­tween com­pa­ra­ble ver­sions of the same ac­tive sub­stance ap­proved in ac­cor­dance with EU leg­is­la­tion is not ex­pect­ed to trig­ger or en­hance im­muno­genic­i­ty. On the ba­sis of cur­rent knowl­edge, it is un­like­ly and very dif­fi­cult to sub­stan­ti­ate that two prod­ucts, com­pa­ra­ble on a pop­u­la­tion lev­el, would have dif­fer­ent safe­ty or ef­fi­ca­cy in in­di­vid­ual pa­tients up­on a switch. Our con­clu­sion is that biosim­i­lars li­censed in the EU are in­ter­change­able.

The Eu­ro­pean con­cept of in­ter­change­abil­i­ty is al­so dif­fer­ent than in the US, as de­ci­sions re­gard­ing med­i­cine sub­sti­tu­tion at the phar­ma­cy lev­el (i.e. the prac­tice of dis­pens­ing one med­i­cine in­stead of an­oth­er with­out con­sult­ing the pre­scriber) are man­aged by in­di­vid­ual EU mem­ber states, the EMA notes.

The po­si­tion comes as Eu­rope has gained ad­di­tion­al ex­pe­ri­ence in re­view­ing and ap­prov­ing biosim­i­lars so far, with 86 ap­provals since 2006, com­pared with 38 ap­provals in the US since 2015.

Of those ap­provals in the US, on­ly three biosim­i­lars have won this in­ter­change­abil­i­ty des­ig­na­tion, in­clud­ing one for in­sulin, Vi­a­tris and Bio­con’s Sem­glee; one for Ab­b­Vie’s Hu­mi­ra, Boehringer In­gel­heim’s Cyl­te­zo; and one for Roche’s Lu­cen­tis and Co­herus Bio­Sciences’ Cimer­li.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; 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.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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Up­dat­ed: Al­ny­lam re­in­forces APOL­LO-B patisir­an da­ta be­fore head­ing to the FDA

Weeks after uncorking some mostly positive data for patisiran in transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy, Alnylam is bolstering its package with new exploratory and subgroup data before shipping it off to regulators.

The RNAi drug maintained “generally consistent” benefits in efficacy and quality of life across several prespecified subgroups at month 12, Alnylam announced on Friday afternoon, including age, baseline tafamidis use, ATTR amyloidosis type, baseline six-minute walk test score and others.

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Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

#AAO22 conference in Chicago (Photo credit: Associate editor Kyle LaHucik)

#AAO22: In bid for first FDA nod in ge­o­graph­ic at­ro­phy, Apel­lis claims an­oth­er first in eye dis­ease field

CHICAGO — Eight weeks before patients and industry find out if the FDA approves the first treatment for geographic atrophy, an advanced form of age-related macular degeneration, the biotech behind the drug is out with some new data on a secondary endpoint.

In what study investigator Charles Wykoff called the “first direct evidence of function preservation by slowing GA growth” in an investigational treatment, Apellis Pharmaceuticals’ drug pegcetacoplan led to less loss of retinal sensitivity versus sham  within 250 microns on either side of the GA lesion over 24 months.

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BioCryst's new website for its HAE unbranded campaign encourages patients to take charge of treatment decisions.

BioCryst launch­es aware­ness cam­paign around man­age­ment of rare vas­cu­lar dis­ease

While hereditary angioedema (HAE) is rare, treatment options for the condition have become much more common. So BioCryst Pharmaceuticals is taking a new angle in its recently launched HAE awareness campaign encouraging patients to take control of their disease management.

“Hereditary angioedema (HAE) isn’t the author of your story — you are … #cHAEngetheplan. Not the goal,” the US campaign website advises.

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