United States

Direct seller's going to need more than larger number of distributors to generate sustainable growth, analysts say.

Firm’s future, as a separate business nearly 90% owned by Bausch Health, or as a standalone with different ownership or one not controlled by a majority owner, claims high profile in analysts’ comments and predictions. B+L is in the driver’s seat, they say.

Sponsors of generic drug applications that miss a goal date, but do not receive an action because of complex scientific or legal questions, would get a notice outlining the lingering issue as part of a new pilot program that might become permanent in the next review cycle.

Beachbody offers supplement sales using health savings accounts; PlantX, Boka launches oral health supplements; supplements take Form from RTE meal provider Factor; LIV3 JV behind marketing SugarShield; Ghost among Keurig Dr Pepper brands; and Nutra-Med Packaging expands with Legacy Pharma.

In a citizen petition to the FDA, Alvotech has called on the US agency to refrain from approving as interchangeable certain Stelara biosimilars that use a different cell line to its own ustekinumab product – including the Pyzchiva version set to be brought to market by Samsung Bioepis and Sandoz.

All eyes are on Eylea, after Amgen said last week that it would launch the first US biosimilar in the face of ongoing litigation. The California-based player has spoken of its prospects in the wet-AMD space, including a desire to chart its own path amid supply shortages for Avastin.

The wait for US competition to AbbVie’s Lumigan 0.01% glaucoma brand, launched more than a decade ago, goes on, after Mankind bowed to infringement of a key US patent.

Trade group ready to work hand-in-hand with agency and other supplement industry stakeholders on potential regulatory changes or improvements, says president and CEO Steve Mister. “None of them are upsetting the basic balance of things that DSHEA was attempting to do, but there are things with 30 years that we've identified that need to be kind of fixed.”

In a citizen petition to the FDA, Alvotech has called on the US agency to refrain from approving as interchangeable certain Stelara biosimilars that use a different cell line to its own ustekinumab product – including the Pyzchiva version set to be brought to market by Samsung Bioepis and Sandoz.

While Roche admits that an acceleration of biosimilar competition to its blockbuster IL-6 inhibitor Actemra/RoActemra is anticipated in the final three months of the year, the Swiss originator has been surprised by the lack of challenge to its franchise so far.