FDA of­fers a pro­pos­al to help gener­ic drug de­vel­op­ers get si­mul­ta­ne­ous ap­provals in mul­ti­ple mar­kets

The FDA re­vealed Thurs­day that it’s of­fer­ing a pro­pos­al to the In­ter­na­tion­al Coun­cil on Har­mon­i­sa­tion — ICH — to bet­ter har­mo­nize sci­en­tif­ic and tech­ni­cal stan­dards for gener­ic drugs.

The plan is to let gener­ic drug de­vel­op­ers im­ple­ment a sin­gle glob­al drug de­vel­op­ment pro­gram, with com­mon el­e­ments of ap­pli­ca­tions to file, which will al­low for si­mul­ta­ne­ous ap­provals in mul­ti­ple mar­kets.

“This would make it eas­i­er for de­vel­op­ers that would oth­er­wise on­ly seek gener­ic drug ap­proval in one re­gion to al­so seek ap­proval in the Unit­ed States, in­creas­ing com­pe­ti­tion in Amer­i­ca. And it would al­so make it eas­i­er for de­vel­op­ers that would oth­er­wise on­ly seek gener­ic drug ap­proval in the US mar­ket to gain ac­cess to oth­er mar­kets,” FDA com­mis­sion­er Scott Got­tlieb said in a state­ment.

More specif­i­cal­ly, FDA is propos­ing that ICH de­vel­op a se­ries of guide­lines on stan­dards for demon­strat­ing bioe­quiv­a­lence for both non-com­plex and com­plex dosage forms, and drug prod­ucts. FDA ex­pects that ICH will re­view FDA’s pro­pos­al and that the ICH As­sem­bly will en­dorse the pro­pos­al at its next meet­ing in No­vem­ber 2018.

As far as ar­eas for po­ten­tial con­sid­er­a­tion, There­sa Mullin, as­so­ciate di­rec­tor for strate­gic ini­tia­tives at FDA, told at­ten­dees of the As­so­ci­a­tion for Ac­ces­si­ble Med­i­cines con­fer­ence in Sep­tem­ber, of the pos­si­bil­i­ties:

  • A se­ries of ICH guide­lines on bioe­quiv­a­lence stan­dards for sim­ple and com­plex dosage forms;
  • Asur­vey of ex­ist­ing ICH guide­lines for up­dat­ing as need­ed to in­cor­po­rate rec­om­men­da­tions for gener­ic drugs.

“These ac­tiv­i­ties in­clude pur­su­ing op­por­tu­ni­ties like a har­mo­nized bioe­quiv­a­lence study de­sign that could be ex­pand­ed to in­clude ad­di­tion­al study arms to ac­com­mo­date more than one ref­er­ence prod­uct for bridg­ing pur­pos­es,” Got­tlieb added.

Man­u­fac­tur­ing spec­i­fi­ca­tions may al­so dif­fer be­tween coun­tries.

“For ex­am­ple, right now a spe­cif­ic drug may need to be test­ed un­der dif­fer­ent dis­so­lu­tion meth­ods and ac­cep­tance cri­te­ria to sat­is­fy both the FDA and the Eu­ro­pean Med­i­cines Agency’s reg­u­la­to­ry re­quire­ments,” Got­tlieb said, not­ing that the lack of har­mo­niza­tion across ba­sic com­po­nents of gener­ic drug de­vel­op­ment re­duces the op­por­tu­ni­ties for gener­ic drug de­vel­op­ers to use their da­ta and in­for­ma­tion across mul­ti­ple ap­pli­ca­tions in dif­fer­ent ju­ris­dic­tions.

AAM said in a state­ment that it sup­ports FDA in this ini­tia­tive and looks for­ward to work­ing close­ly with them on it.

FDA al­so re­cent­ly con­duct­ed a pre­lim­i­nary analy­sis that found there are sig­nif­i­cant op­por­tu­ni­ties to ex­pand the avail­abil­i­ty and in­crease mar­ket com­pe­ti­tion for gener­ic drugs be­yond their cur­rent mar­kets.

In par­tic­u­lar, FDA ex­plored the ques­tion of whether there ap­pear to be op­por­tu­ni­ties for coun­tries to gain ac­cess to gener­ic drugs not cur­rent­ly avail­able. In ad­di­tion to the US mar­ket, FDA used da­ta avail­able from 2017 for a sam­pling of nine oth­er coun­tries in­clud­ing five in the EU (France, Ger­many, Greece, Poland and the UK), Japan, Cana­da, Switzer­land and Aus­tralia.

“First, FDA looked at whether the top 100 drugs dis­pensed in the U.S. were al­so avail­able in those nine oth­er coun­tries and found that all of the nine ex­pe­ri­enced some lack of avail­abil­i­ty of these drugs, which ranged from 5 (of 100) un­avail­able in Cana­da to 25 (of 100) un­avail­able in Japan,” Got­tlieb said.

“Next, FDA ex­am­ined the set of ap­prox­i­mate­ly 400 gener­ic drugs with the low­est vol­umes sold in the U.S. used as a proxy for low­est lev­el of U.S. avail­abil­i­ty. FDA found that on­ly 35 per­cent of these drugs were avail­able in the oth­er nine coun­tries and 65 per­cent of these drugs ap­pear to be un­avail­able,” he added.

First pub­lished here. reg­u­la­to­ry fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Levi Garraway, Roche CMO (Source: Genentech)

UP­DAT­ED: FDA hands out a quick OK for po­ten­tial SMA block­buster ris­diplam, giv­ing Genen­tech and Roche a chance to chal­lenge ri­vals on the price

US regulators handed Roche and Genentech a big win Friday afternoon, one that has market-shaping potential for its high-priced rivals from Novartis and Biogen.

The FDA has green-lit the companies’ spinal muscular atrophy drug risdiplam, which will be marketed as Evrysdi in the US, for use in patients two months and older. It’s the first SMA drug that can be taken orally, as Biogen’s Spinraza is injected into the spine while Novartis’ Zolgensma is a gene therapy.

Moncef Slaoui, Getty Images

When will it end? Big Phar­ma's top vac­cine ex­pert at OWS of­fers a speedy time­line for a Covid-19 vac­cine — ei­ther be­fore or right af­ter the elec­tion

Moncef Slaoui hasn’t started making plans for his summer vacation next year. But he offers high odds that all Americans will be able to do that in the not too distant future.

In an interview with a pair of sympathetic podcasters at the conservative American Enterprise Institute, Slaoui provides an education to listeners on how any drug or vaccine can be sped through trials. And he leaves the door wide open to the notion that the leading vaccine developers can demonstrate efficacy and safety in a compelling fashion as early as October — or as late as the end of this year.

President Trump (AP Images)

UP­DAT­ED: FDA takes the lead on defin­ing es­sen­tial un­der Trump's 'Buy Amer­i­can' ex­ec­u­tive or­der — as phar­ma warns of sup­ply chain dis­rup­tion

President Donald Trump has signed an executive order detailing how the federal government should help on-shore drug manufacturing — and the FDA will play a central role.

The agency now has three months to draw up the list of “essential medicines, medical countermeasures, and their critical inputs” that the US must have available at all times. Various departments and agencies are then directed to buy these drugs and their ingredients from American manufacturers.

Covid-19 roundup: Gates Foun­da­tion pours $150M in­to In­dia’s Serum In­sti­tute; Pfiz­er teams with Gilead on remde­sivir

By CEO and scion Adar Poonawalla’s estimation, the Serum Institute in India has already poured hundreds of millions of dollars into scaling up the unproven Covid-19 vaccine being developed by AstraZeneca and Oxford for use in low and middle income countries. It’s meant taking on a risk that other companies, including AstraZeneca, have mitigated with huge amounts of government funding.

Now, for the first time, Poonawalla is getting some outside help. The Gates Foundation has agreed to pay the institute $150 million to supply 100 million vaccines to India and other emerging economies next year, Reuters reported. That includes both the vaccine being developed by AstraZeneca and the one being developed by Novavax. Those vaccines will be available in 92 countries and be priced at $3 per dose.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Bio­haven adds near­ly $1B in Nurtec deals with Roy­al­ty Phar­ma, Sixth Street

Biohaven just added nearly $1 billion to their balance sheet.

On Friday morning, the neuroscience biotech announced a pair of creative agreements with Royalty Pharma and the investment firm Sixth Street to bolster the commercial launch of their new migraine drug, Nurtec. Biohaven will sell a sliver of its royalties on Nurtec and 3% of the royalties on their experimental migraine drug zavegepant to Royalty Pharma as part of a larger agreeement that will pay $450 million. At the same time, the company announced they took out a $500 million loan from Sixth Street.

Ab­b­Vie set­tles in­sur­ance fraud suit, agrees to tweak nurse am­bas­sador pro­gram; CStone aims for NSCLC OK with pos­i­tive PhI­II da­ta

AbbVie has resolved a California lawsuit alleging insurance fraud in the promotion of its cash cow Humira, paying $24 million to settle things with the state’s insurance regulator.

The settlement comes almost four years after a whistleblower first reported AbbVie’s practice of deploying registered nurses to visit patients at home or call them by phone to ensure that Humira prescriptions are filled. AbbVie was also charged with providing illegal kickbacks to doctors in an attempt to encourage them to prescribe Humira for a range of anti-inflammatory diseases.