Move over, Lu­cen­tis. The FDA has ap­proved the first in­ter­change­able biosim­i­lar to Roche’s block­buster an­ti-VEGF drug.

Co­herus’ Cimer­li is ex­pect­ed to hit the mar­ket in Oc­to­ber af­ter get­ting the FDA’s thumbs-up in five reti­nal in­di­ca­tions, the com­pa­ny an­nounced on Tues­day. Cimer­li isn’t the first biosim­i­lar to ri­val Roche’s eye drug — but it is the first to win in­ter­change­able sta­tus, mean­ing it can be sub­sti­tut­ed at the phar­ma­cy in some cas­es.

“We’ve hired a ded­i­cat­ed reti­na sales team, all of whom have years of ex­pe­ri­ence sell­ing to reti­na spe­cial­ists,” a Co­herus spokesper­son said in an email to End­points News. 

Lu­cen­tis, al­so known as ranibizum­ab in­jec­tion, was first ap­proved back in 2006 for wet AMD, a chron­ic eye dis­or­der that can lead to blind­ness. It has since picked up a suite of in­di­ca­tions, from di­a­bet­ic retinopa­thy (DR) to di­a­bet­ic mac­u­lar ede­ma (DME).

Cimer­li is ap­proved to treat wet AMD, DR, DME, mac­u­lar ede­ma fol­low­ing reti­nal vein oc­clu­sion (RVO), and my­opic choroidal neo­vas­cu­lar­iza­tion (mC­NV).

While Lu­cen­tis raked in $1.4 bil­lion last year, the mar­ket is a bit more crowd­ed now. Sam­sung Bioepis and Bio­gen snagged ap­proval ear­li­er this year for the US’ first Lu­cen­tis biosim­i­lar, By­ooviz, in three in­di­ca­tions in­clud­ing wet AMD. While Bio­gen and Sam­sung priced By­ooviz at a rough­ly 40% dis­count to Lu­cen­tis, ac­cord­ing to Mizuho’s Sal­im Syed, Co­herus has not yet com­ment­ed on pric­ing.

Co­herus not­ed Cimer­li’s in­ter­change­able sta­tus and pos­i­tive head-to-head re­sults, adding that: “These com­bined will give reti­nal spe­cial­ists a high de­gree of con­fi­dence to pre­scribe CIMER­LI for pa­tients cur­rent­ly re­ceiv­ing Lu­cen­tis as well as for any new­ly di­ag­nosed new pa­tient with­in in­di­ca­tion, and our mar­ket re­search con­firms that de­pend­ing on ac­cess and prac­tice eco­nom­ics, op­por­tu­ni­ty ex­ists to ex­pand CIMER­LI use in­to Avastin and Eylea.”

Roche’s Genen­tech, how­ev­er, isn’t go­ing down with­out a fight. Back in Oc­to­ber, the phar­ma gi­ant got ap­proval for Susvi­mo, a new ranibizum­ab ad­min­is­tra­tion route that al­lows wet AMD pa­tients to ditch their cur­rent month­ly in­jec­tions and opt in­stead for as few as twice-an­nu­al treat­ments.

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.

Days after Enhertu reeled in another FDA nod, with the first-ever green light for HER2-low breast cancer, another antibody drug conjugate biotech claims it has secured the largest preclinical ADC pact to date for a single asset.

AstraZeneca and Daiichi Sankyo made waves with their nearly $7 billion collaboration back in spring 2019, but at that point, Enhertu was already nearing the FDA’s doors with clinical data. The latest ADC tie-up to enter the biopharma fray centers around a preclinical asset, Mersana Therapeutics’ XMT-2056.