Pfiz­er fi­nal­ly fin­ish­es a 3-year reg­u­la­to­ry odyssey, bag­ging an FDA OK for 1st Epogen knock­off

A decade af­ter Hos­pi­ra launched its biosim­i­lar of Am­gen’s ag­ing ane­mia drug Epogen in Eu­rope, its suc­ces­sors at Pfiz­er have fi­nal­ly pushed it over the fin­ish line at the FDA. The ap­proval of the first Epogen copy­cat to­day — sold by J&J as Pr­o­crit — comes af­ter their knock­off Re­tacrit was snubbed twice at the FDA, first in 2015 and again last sum­mer, when reg­u­la­tors voiced dis­sat­is­fac­tion with their man­u­fac­tur­ing cen­ter.

Leah Christl

The reg­u­la­to­ry path­way proved much longer and hard­er than Pfiz­er an­tic­i­pat­ed when it bought Hos­pi­ra in 2015. But the phar­ma gi­ant has been plug­ging away, join­ing No­var­tis, Cell­tri­on and Am­gen it­self as they ad­vanced var­i­ous gener­ic copies of first-gen­er­a­tion bi­o­log­ics to the FDA. 

Un­der com­mis­sion­er Scott Got­tlieb, the FDA has voiced its will­ing­ness to help move things along as ef­fi­cient­ly as pos­si­ble, but that hasn’t pre­vent­ed a se­ries of re­jec­tions over the past few years.

Epogen was first ap­proved by the FDA in 1989, cre­at­ing a fran­chise that sus­tained Am­gen as it de­vel­oped Big Phar­ma sta­tus. And Am­gen con­tin­ued to wage a long-run­ning le­gal bat­tle to de­lay the ar­rival of Re­tacrit, even though in the long run it didn’t need to. The FDA ac­com­plished that task on its own.

Even as the Eu­ro­pean ri­val ate in­to Epogen’s rev­enue and Am­gen low­ered prices, it’s been a durable block­buster, earn­ing a lit­tle more than a bil­lion dol­lars last year af­ter gar­ner­ing about $1.3 bil­lion in 2016. But its block­buster days are num­bered, es­pe­cial­ly as the Trump ad­min­is­tra­tion push­es low­er cost al­ter­na­tives as a way to re­duce the coun­try’s drug bill.

“It is im­por­tant for pa­tients to have ac­cess to safe, ef­fec­tive and af­ford­able bi­o­log­i­cal prod­ucts and we are com­mit­ted to fa­cil­i­tat­ing the de­vel­op­ment and ap­proval of biosim­i­lar and in­ter­change­able prod­ucts,” said Leah Christl, di­rec­tor of the Ther­a­peu­tic Bi­o­log­ics and Biosim­i­lars Staff in the FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search. “Biosim­i­lars can pro­vide greater ac­cess to treat­ment op­tions for pa­tients, in­creas­ing com­pe­ti­tion and po­ten­tial­ly low­er­ing costs.”

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

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Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

In­tro­duc­ing End­pointsF­DA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

UP­DAT­ED: Feds clear the road for J&J to start de­liv­er­ing mil­lions of dos­es of their Covid-19 vac­cine — but frets linger about run­ner-up sta­tus

All the pieces needed to trigger a third wave of Covid-19 vaccine supply to start washing over the US fell neatly into place over the weekend.

After providing for a brief mime of regulatory judiciousness, the FDA stamped their emergency approval on J&J’s Covid-19 vaccine Saturday, adding to the Biden administration’s plan aimed at ending the pandemic in the near term — at least in the US. The CDC came through on Sunday with its stamp of approval and J&J is reportedly expected to start delivering vaccine sometime in the next few days.

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