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.”

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Pfiz­er, Sarep­ta and two oth­ers sug­gest Duchenne drug safe­ty is­sues tied to "class ef­fect"

Since the first experimental Duchenne gene therapy programs came about, the space has proven rife with safety issues and patient deaths in clinical trials. Pfizer and three biotechs now think they’ve found a reason why.

The four companies suggested there may be a “class effect” causing the adverse events in Duchenne gene therapies, they wrote in a new study. They specifically highlighted how side effects in five patients across three trials, who all showed muscle weakness with cardiac involvement, were “strikingly similar.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

De­spite fed­er­al ef­forts to di­ver­si­fy clin­i­cal tri­als, progress re­mains 'stag­nan­t' — re­port

While calls to diversify clinical trials have grown louder in recent years — gaining support from federal agencies such as the FDA and NIH — progress has largely stalled, according to a new report from the National Academies of Sciences, Engineering and Medicine.

Swaths of patients in racial and ethnic minority groups, as well as LGBTQIA+, pregnant and older adult populations continue to be left out of clinical trials. While some advances have been made in the last 30 years — women now account for roughly half of clinical trial participants — growth in other areas remains stagnant, according to the report, which was mandated by Congress and sponsored by the NIH.

Paul Chaplin, Bavarian Nordic president and CEO

Bavar­i­an Nordic se­cures BAR­DA con­tract for small­pox vac­cine

It seems that smallpox vaccination production is weighing on the mind of the US government. And manufacturer Bavarian Nordic is the latest company to benefit.

Just a few days after Emergent, a company that has made government contracts its lifeblood, acquired the exclusive rights to Tembexa from Chimerix, with a $225 million cash payment and an expected BARDA contract, the agency has offered a contract for smallpox vaccine production.

Lina Khan, FTC chair (Saul Loeb/Pool via AP)

New FTC com­mis­sion­er could turn the tide for an in­ves­ti­ga­tion in­to PBMs

The Senate last week voted along party lines, 51-50, with Vice President Kamala Harris casting the tie-breaker, to make President Biden appointee Alvaro Bedoya the deciding vote on a split 2-2 Federal Trade Commission.

The addition of Bedoya to the FTC could not only spell more trouble for biopharma M&A activity, as he may align with his Democrat partners to break the FTC ties, but it may also mean that FTC Chair Lina Khan has what she needs to move forward on a study around the pharma middlemen known as pharmacy benefit managers.

Patty Murray (D-WA) (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Long-ex­pect­ed UK lay­offs im­mi­nent for No­var­tis fol­low­ing sale

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.