Al­most 10 years have passed since its first FDA ap­proval and Re­gen­eron’s mac­u­lar de­gen­er­a­tion in­jec­tion Eylea con­tin­ues to pile up sales to the tune of about $5 bil­lion per year, or more than half of Re­gen­eron’s an­nu­al rev­enues.

Those bil­lions are not ex­pect­ed to go any­where any­time soon thanks to com­pe­ti­tion, even as No­var­tis sub­sidiary San­doz an­nounced Mon­day that it’s be­gin­ning a Phase III tri­al for an Eylea biosim­i­lar in 460 pa­tients across 20 coun­tries.

Ge­of­frey Porges

SVB Leerink biotech an­a­lyst Ge­of­frey Porges said in an in­vestor note on Mon­day that al­though San­doz has a strong rep­u­ta­tion for qual­i­ty biosim­i­lars since the in­cep­tion of biosim­i­lars in the US (the first-ever FDA ap­proval for a biosim­i­lar went to San­doz’s Zarxio), an ap­proval for the Eylea biosim­i­lar may not come un­til 2024 or 2025.

And by then, the mar­ket may have changed.

“We be­lieve 2024 will be a dis­ad­van­ta­geous time for an Eylea biosim­i­lar to en­ter the mar­ket since Eylea may po­ten­tial­ly have the high-dose for­mu­la­tion on the mar­ket along with com­peti­tors that should ex­tend treat­ment in­ter­vals much longer than every 12 weeks,” Porges wrote.

He al­so said to ex­pect mar­ket share loss from Eylea to be dri­ven by the en­trance of com­peti­tors that en­able im­proved vi­su­al acu­ity.

Eylea com­peti­tors out­side of the biosim­i­lar space may come from Roche, No­var­tis, As­cle­piX, Ko­di­ak, or oth­ers.

And Re­gen­eron’s cash cow al­so may be ex­posed to any po­ten­tial con­gres­sion­al ac­tion to low­er drug prices or spend­ing re­lat­ed to Medicare Part B.

Eylea is the top-sell­ing drug in Medicare Part B. Since 2013, the pro­gram has spent more than $11.5 bil­lion on the drug, which typ­i­cal­ly costs over $10,000 per year.

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.