For­get biosim­i­lars. Pe­ter Bach and Mark Trusheim be­lieve price con­trols are the bet­ter way to rein in bi­o­log­ics prices

The prover­bial so­cial con­tract that drug­mak­ers of­ten cite to de­fend pre­scrip­tion drug prices hinges on the im­age of a patent cliff: Af­ter a pe­ri­od of ex­clu­siv­i­ty that al­lows de­vel­op­ers to re­coup R&D costs, any treat­ment — even those with ex­or­bi­tant price tags — even­tu­al­ly suc­cumb to gener­ic com­pe­ti­tion that in­evitably brings down its cost, if not ren­der it ob­so­lete.

That mod­el has large­ly held true for small mol­e­cule drugs. But out­spo­ken pol­i­cy re­searchers Pe­ter Bach and Mark Trusheim, along with two of Bach’s as­so­ciates at the Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter, are ar­gu­ing that the new gen­er­a­tion of bi­o­log­ics may need an ex­tra push down that cliff, and the force of biosim­i­lars won’t be enough.

Bi­o­log­ics, they write in a two-part blog­post in Health Af­fairs, are fun­da­men­tal­ly dif­fer­ent from small mol­e­cules, cre­at­ing nat­ur­al mo­nop­o­lies that are dif­fi­cult to over­come with com­pe­ti­tion-based price re­duc­tions:

While the mo­nop­oly held by in­no­va­tor small mol­e­cules is a prod­uct of gov­ern­ment poli­cies, in­no­v­a­tive bi­o­log­ic ther­a­pies pos­sess in­trin­sic sci­en­tif­ic un­cer­tain­ties that make cre­at­ing repli­cas dif­fi­cult, cost­ly, slow, and risky. Com­peti­tors to brand­ed bi­o­log­ics are called biosim­i­lars rather than “bio-iden­ti­cals” or gener­ics to re­flect this dif­fer­ence.

Mark Trusheim

Giv­ing up en­tire­ly on biosim­i­lars, Bach, Trusheim (of MIT Sloan), Pre­ston At­te­ber­ry and Jen­nifer Ohn pro­pose a reg­u­la­to­ry ap­proach to rein­ing in bi­o­log­ics costs that they say can gen­er­ate $250-$300 bil­lion of net sav­ings, while in­cur­ring one-time costs of $10-$20 bil­lion over five years. Their es­ti­mates for sav­ings are based on “the cur­rent 12-year ex­clu­siv­i­ty pe­ri­od and an as­sump­tion that dis­counts ap­proach the tra­di­tion­al gener­ic dis­counts of 70-90 per­cent,” while the one-time costs go to­ward com­pen­sat­ing biosim­i­lar firms.

The pol­i­cy would re­quire in­no­va­tor bi­o­log­ic man­u­fac­tur­ers to low­er their prices af­ter the pe­ri­od of mar­ket ex­clu­siv­i­ty — a price set by an in­de­pen­dent body that takes in­to ac­count the re­port­ed cost, a markup, a de­fined prof­it mar­gin, re­turn on cap­i­tal and so on.

The au­thors an­tic­i­pat­ed some push­back. You can be sure that fresh­ly re­tired FDA com­mis­sion­er Scott Got­tlieb was among the first to de­fend con­tin­ued pol­i­cy­mak­ing around biosim­i­lars.

A vo­cal cham­pi­on of biosim­i­lars as a means of low­er­ing drug prices, Got­tlieb has pre­vi­ous­ly lam­bast­ed a “rigged pay­ment scheme” on the in­sur­ance and phar­ma­cy ben­e­fit man­agers side that hin­der mar­ket pen­e­tra­tion for biosim­i­lars.

The Biosim­i­lar Coun­cil, a di­vi­sion of the gener­ic drug­mak­er coali­tion known as the As­so­ci­a­tion for Ac­ces­si­ble Med­i­cines, told Bio­Cen­tu­ry that “mar­ket­ed biosim­i­lars cur­rent­ly av­er­age 47% off the brand bi­o­log­ics’ price” and aban­don­ing it al­to­geth­er would be “toss­ing out the ba­by with the bath wa­ter.”

Some al­so took is­sue with the premis­es of the ar­gu­ment.

As a no­table talk­ing point of Pres­i­dent Don­ald Trump’s plan for low­er­ing drug prices — with big bio­phar­ma play­ers like Pfiz­er and Bio­gen dou­bling down on their in­vest­ments — biosim­i­lars are un­like­ly to go away any time soon. But Bach’s will be one of many ideas to come as politi­cians and com­pa­nies alike fran­ti­cal­ly search for ways to tam­per the roar­ing de­bate around high pre­scrip­tion drug prices, in which ex­pen­sive bi­o­log­ics play an ever en­larg­ing role.


Im­age: Pe­ter Bach at an End­points pan­el, Jan­u­ary 2019.

In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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UP­DAT­ED: Have a new drug that promis­es to fight Covid-19? The FDA promis­es fast ac­tion but some de­vel­op­ers aren't hap­py

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

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Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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The race to de­vel­op Covid-19 drugs and vac­cines is on — here’s what’s hap­pen­ing in the UK

Weeks away from the results of ongoing US and China trials testing its experimental antiviral remdesivir, Gilead is going to trial the failed Ebola drug in a small group of coronavirus patients in England and Scotland. The United Kingdom is also home to a range of other therapeutic efforts, as the pandemic rages on across the globe.

On Tuesday, Southampton, UK-based startup Synairgen kicked off a mid-stage placebo-controlled study testing its experimental drug, SNG001 — an inhaled formulation of interferon-beta-1a — that has previously shown to be safe and effective in improving lung function in asthma patients with a respiratory viral infection in a pair of Phase II trials.

‘There was a grow­ing weari­ness’: Rush­ing against a pan­dem­ic clock, As­pen Neu­ro­sciences se­cures $70M Se­ries A

Just before Christmastime, Howard Federoff got a tip from Washington: There was a new virus in China. And this one could be bad.

News report of the virus had not yet appeared. Federoff, a neuroscientist, was briefed because years before, he was vetted as part of a group — he didn’t give a name for the group — to consult for the US government on emerging scientific issues. His day job, though, was CEO of Aspen Neurosciences, a Parkinson’s cell therapy startup that days before had come out of stealth mode and gave word to investors they were hoping to raise $70 million. That, Federoff realized, would be difficult if a pandemic shut down the global economy.

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As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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FDA puts pe­di­atric aGVHD drug on pri­or­i­ty re­view lane — will they go vir­tu­al with the ad­comm?

Despite worries about regulatory delays due to new work arrangements under Covid-19, the FDA appears intent to go full speed ahead with its everyday work, not only granting priority review to a stem cell therapy for acute graft versus host disease but also plotting an advisory committee meeting for it.

With a PDUFA date of September 30, the journey of the drug — remestemcel-L, or Ryoncil — could shed light on the agency’s capacity to facilitate drug development unrelated to Covid-19.

Covid-19 roundup: Trump push­es his new fa­vorite, untest­ed drug; CRISPR out­lines crip­pling im­pact of Covid-19

President Trump has a new favorite Covid-19 drug.

After a conversation with Japanese Prime Minister Shinzo Abe, Politico reports, the president is pressuring the FDA to issue emergency use authorization for favipiravir, a flu drug that showed glimpses of success in China but remains unproven and carries a list of worrying side effects. The push comes after a week-plus in which the White House touted a potentially effective but unproven malaria medication despite the concerns of scientific advisors such as NIAID director Anthony Fauci. And Trump ally Rudy Giuliani has been talking up unproven cell therapy efforts on Twitter.

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