Ab­b­Vie digs in for a long war as Am­gen bags first OK for a Hu­mi­ra biosim­i­lar

The FDA pro­vid­ed its stamp of ap­proval on Am­gen’s biosim­i­lar of Ab­b­Vie’s an­ti-in­flam­ma­to­ry megablock­buster Hu­mi­ra. But don’t look for any cheap­er copies of the drug any­time soon. Ab­b­Vie plans to fight to the last lawyer keep­ing the com­peti­tor off the mar­ket, claim­ing it has patents in place to bar this and oth­er ri­vals in the works for an­oth­er six years.

Janet Wood­cock

Ab­b­Vie has plen­ty to gain and much to lose when it comes to Hu­mi­ra and the biosim­i­lar mar­ket. The com­pa­ny earned about $14 bil­lion off the one fran­chise last year, and the num­bers keep head­ed north. In the sec­ond quar­ter, its flag­ship drug brought in $4.15 bil­lion. Hu­mi­ra pro­vides rough­ly two thirds of its rev­enue and Ab­b­Vie has been fight­ing for more time — lots more time — to de­vel­op new drugs to take its place.

Am­gen, mean­while, will be push­ing to get their copy­cat — named Am­je­vi­ta — on the mar­ket some­time next year, hop­ing that once the main patent laps­es in De­cem­ber they can fight their way out front. Mean­while, Mer­ck/Sam­sung Bioepis, No­var­tis and Shire (Bax­al­ta)/Mo­men­ta al­so have knock­offs in the clin­ic, look­ing to line up for a share of the mar­ket as well.

The slate of new ap­provals on biosim­i­lars, with one un­ex­plained re­jec­tion for No­var­tis, has helped il­lu­mi­nate the FDA’s at­ti­tudes to­ward biosim­i­lars. Clean da­ta on one cen­tral in­di­ca­tion ap­pears good enough to win ap­provals for a full slate of in­di­ca­tions. And the agency ap­pears ready to move quick and fast to green light these drugs, even if patent bat­tles are like­ly to take much longer to play out.

Am­gen, for ex­am­ple, has been play­ing de­fense on the biosim­i­lars front as well as of­fense. The com­pa­ny has been fight­ing a de­lay­ing ac­tion against No­var­tis’ ap­proved ri­val Zarxio, a copy of ne­u­pogen.

“This is the fourth FDA-ap­proved biosim­i­lar. The biosim­i­lar path­way is still a new fron­tier and one that we ex­pect will en­hance ac­cess to treat­ment for pa­tients with se­ri­ous med­ical con­di­tions,” said Janet Wood­cock, M.D., di­rec­tor of the FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

Joe Papa (Ryan Remiorz/The Canadian Press via AP, File)

Joe Pa­pa re­signs as chair of Bausch Health as bil­lion­aire John Paul­son takes over

Joe Papa, chair of Bausch Health, officially resigned on Thursday and the board appointed billionaire hedge fund manager John Paulson as the new chair, effective immediately.

The specialty pharma company sought to make clear that Papa’s abrupt departure “was not due to any dispute or disagreement with the Company, its management or the Board on any matter relating to the Company’s operations, policies or practices.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

When will the FDA re­scind a break­through des­ig­na­tion? New draft guid­ance spells out the com­pli­cat­ed de­tails

Although it’s exceedingly rare for the FDA to rescind a breakthrough designation once it’s granted, there has been a recent uptick — as in 2020 and 2021 combined, the agency rescinded 17 BTDs, compared to just 18 rescinded from 2015 to 2019 combined.

Protagonist Therapeutics saw this reality up close and personal in April after a clinical hold lifted on its experimental blood cancer drug, as the company revealed that the FDA sought to revoke the BTD. The decision, Protagonist says, stems from “observed malignancies” related to the hold, initially imposed in September 2021.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.