Am­gen took their ar­gu­ment that its biosim­i­lar ri­vals should be forced to de­lay their 180-day mar­ket­ing no­tices un­til af­ter the FDA had made up its mind on the mar­ket­ing ap­pli­ca­tion all the way to the Supreme Court — and lost.

In a unan­i­mous rul­ing hand­ed down mid-day Mon­day, the Supreme Court de­cid­ed the key ques­tion by de­ter­min­ing that the law nev­er im­posed a two-tier tim­ing sys­tem for these no­tices. There­fore “the ap­pli­cant may pro­vide no­tice ei­ther be­fore or af­ter re­ceiv­ing FDA ap­proval.”

That marked a clear win for San­doz, the big No­var­tis gener­ics unit which is field­ing a full slate of these copy­cat bi­o­log­ics. The group is launch­ing a knock­off of Am­gen’s Ne­u­pogen, and in the process helped speed the ar­rival of a fresh wave of biosim­i­lars hit­ting US mar­ket shores.

It’s a set­back for Am­gen, but be­fore the Supreme Court ruled against it, the phar­ma gi­ant was able to cel­e­brate a dif­fer­ent kind of win. The FDA re­ject­ed Co­herus’ ap­pli­ca­tion for a biosim­i­lar of Neu­las­ta, which ef­fec­tive­ly de­lays any ri­val there from this year un­til 2018, at the ear­li­est.

Lawyers for San­doz had ar­gued that Con­gress clear­ly nev­er in­tend­ed to pro­vide bonus time to the 12 years of mar­ket­ing ex­clu­siv­i­ty pro­vid­ed by the law. And the com­pa­ny cel­e­brat­ed the rul­ing Mon­day af­ter­noon.

“The Jus­tices’ unan­i­mous rul­ing on the no­tice of com­mer­cial mar­ket­ing will help ex­pe­dite pa­tient ac­cess to life-en­hanc­ing treat­ments. We al­so ap­pre­ci­ate the clar­i­ty pro­vid­ed on the patent dance, which will help the biosim­i­lars in­dus­try move for­ward,” said Car­ol Lynch, Glob­al Head of Bio­phar­ma­ceu­ti­cals, San­doz, in a state­ment. “As the glob­al leader in biosim­i­lars, it is our re­spon­si­bil­i­ty to help elim­i­nate bar­ri­ers so pa­tients can ac­cess more af­ford­able med­i­cine. The re­sults of this Supreme Court case re­in­force that the work we are do­ing every day has mean­ing to the pa­tients and cus­tomers we are here to help.

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.