Intellectual Property

Sandoz has indicated that Amgen’s recently-announced at-risk US launch of a rival to Eylea doesn’t change its thinking around launch timing for its own FDA-approved aflibercept biosimilar.

The latest twist in MSN’s legal fight with Novartis over Entresto has seen a US court rule that the FDA was correct to approve MSN’s skinny-label generic, which carves out certain protected Entresto indications. However, an appeal has already been filed and an imminent generic launch looks unlikely.

In the space of a few days, all four generics manufacturers that had successfully petitioned for a re-examination of a key patent shielding Novo Nordisk’s mega blockbuster Ozempic have reached settlement agreements terminating their challenges.

Fresenius Kabi is facing up to a patent-litigation suit over its proposed biosimilars to Amgen’s Prolia/Xgeva brands – although a prior lawsuit involving biosimilar sponsor Sandoz concluded with a settlement agreement.

The US FTC and FDA both received letters from the Senate but with different messaging. One commends for achieved findings and requests a new investigation and another scalds for not doing the assigned job.

As broad stock markets finished the third quarter of 2024 on a high, two large biotech companies battled on more than one front. Despite both announcing positive news in the last week of the quarter, neither seemed to be a clear winner over that period.

Gilead strikes voluntary licensing agreements with six generic manufacturers for lenacapavir but health groups seek clarity on pricing and seeming API supply restrictions. All eyes are also on the patent opposition case in India.

The world’s best-selling diabetes medicine, with sales last year across the globe of around $14bn, is now in the crosshairs in the US for Viatris’ Mylan and its partner Natco, after the firms announced an agreement settling litigation that was pending before the US Patent and Trademark Office’s Patent Trial and Appeal Board.

Gilead strikes voluntary licensing agreements with six generic manufacturers for lenacapavir but health groups seek clarity on pricing and seeming API supply restrictions. All eyes are also on the patent opposition case in India.

Generics Bulletin reviews several critical US bills and the off-patent industry’s response, along with budget calculations and new proposals.