Litigation

Walmart has launched an attack on a host of industry-leading generics firms over historical price-fixing allegations, with the US retail giant seeking treble damages from a Pennsylvania district court.

CRN petition argues against general preclusion while NPA petition addressed specifically FDA’s wielding of the provision to prohibit the use of NMN supplements available in US. “FDA has acknowledged that they really can't answer one without answering. The two are inextricably linked,” says CRN CEO Steve Mister.

Fresenius Kabi has become the latest biosimilar sponsor to settle US litigation with Amgen over its Prolia/Xgeva rivals. The German firm revealed to Generics Bulletin details of launch dates for its denosumab in both the US and Europe.

It wasn’t a quick decision for Xlear to accept DoJ attorneys’ offer to dismiss the case. “I want the I want the FTC to change its policy and its behaviors,” says Xlear president Nathan Jones.

Health and Human Services Secretary Robert F. Kennedy Jr. is moving FDA Chief Counsel Robert Foster to a new senior position as Chief Counsel for Food, Research, and Drugs at HHS. Hilary Perkins will become FDA chief counsel.

Sandoz CEO Richard Saynor has spoken of his frustration at a lawsuit from J&J seeking to prevent the launch of a private-label ustekinumab biosimilar in the US, which he described as “the desperate actions of an originator trying to protect its market.”

The US Association for Accessible Medicines says it is looking to “protect the public’s interests in ensuring that patents do not let inventors control more than they invented,” as it moved to file in support of MSN Laboratories’ legal tussle with Novartis over a key patent shielding the originator’s $7.8bn Entresto blockbuster.

The same day as Samsung Bioepis and Sandoz launched their partnered Pyzchiva biosimilar rival to Stelara in the US, originator J&J hit the Korean developer with a lawsuit claiming that a private-label commercialization deal with a US pharmacy benefit manager violates the ustekinumab settlement that allowed the firms to launch.

“We have made significant strides in finding new ways to return money to consumers, but a fix to our 13(b) authority is badly needed,” says Sam Levine.

A lot can happen in 24 hours, as Novartis can attest. The Swiss originator has managed to win a court order temporarily putting the brakes on MSN’s Entresto ANDA product – just hours after a lower court refused a similar request.