In the wake of signing a drug transfer and development agreement with Biosimilar Solutions in the firms’ native Puerto Rico, OcyonBio’s CEO Robert Salcedo spoke with Generics Bulletin about the company’s ambitions to put the US territory on the map for biosimilars.
In the space of less than a month, Biosimilar Solutions has initiated registrational clinical trials for biosimilar products referencing the cornerstone granulocyte colony-stimulating factor proteins: Neupogen (filgrastim) and Neulasta (pegfilgrastim).
Biosimilar Solutions is a client and partner of another Puerto Rico-based company, OcyonBio, which describes itself as a cell and gene therapy
The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.
Thanks to its efficient development pipeline, sales of Amgen’s biosimilars neared $750m for the first three months of the year, offering some comfort as the firm gears up for the loss of exclusivity for its denosumab franchise.
During Organon’s first-quarter results call, CEO Kevin Ali discussed the exposure of the biosimilars business to US tariffs, as well as pointing to the recent acquisition of Tofidence (tocilizumab-bavi) from Biogen as an opportunity for growth, as the segment saw a double-digit decline.
As Sandoz continues development of its planned pembrolizumab biosimilar rival to Keytruda, the company has revealed plans to slim down its Phase III trial amid the latest moves from regulators towards streamlining clinical study requirements for biosimilar registration.
After receiving a favorable court ruling last year, Lupin has secured its first-place spot for generic tolvaptan tablets in the US.
As Sandoz continues development of its planned pembrolizumab biosimilar rival to Keytruda, the company has revealed plans to slim down its Phase III trial amid the latest moves from regulators towards streamlining clinical study requirements for biosimilar registration.
Amgen told investors during its 1 May first-quarter earnings call that its Pavblu biosimilar to Eylea 2mg had flown out of the gates, while Regeneron admitted “some difficult news related to our retinal franchise.”
