Manufacturing
Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.
Along with financial backing from the Canadian government, a fresh, decade-long partnership with Sandoz Canada will allow Delpharm to carry out modernization plans for its manufacturing facility in Boucherville, securing the local supply chain for sterile injectable medicines.
Biocon Biologics is partnering with Civica to supply insulin aspart drug substance that will be used for final US manufacturing by Civica at its plant in Petersburg, Virginia.
Viatris anticipates that half-a-billion dollars will disappear from its top line in 2025 on the back of the recent import alert for its oral solids facility in Indore, with much of the pain being caused by the firm’s failure to have its generic version of Revlimid exempt from the restrictions.
South Africa’s Adcock Ingram struck a downbeat tone during its financial first-half results call, as multiple factors conspired to produce a performance “well below expectations.”
In an update to its strategy for dealing with US tariffs, Korea’s Celltrion has revealed actions taken so far, as well as outlining plans to consider moving “swiftly” to secure US manufacturing for APIs if circumstances demand.
Momentum is building around the European Commission’s race to propose a Critical Medicines Act, which aims to tackle drug shortages and create a better framework for establishing manufacturing facilities of essential medicines in the EU.
Speaking during its financial Q3 earnings call, Sun Pharma’s management has again pooh-poohed any idea of jumping into biosimilars in the near future, while providing updates on its trio of stricken Indian manufacturing facilities.
Slovenian firm Krka addressed concerns about potential capacity restrictions during its recent preliminary annual earnings call, stating that it was continuing to work with partners while maintaining its own investments to meet its goals.
Celltrion may consider establishing or acquiring US manufacturing facilities as well as securing more US inventory and shifting its focus onto drug substance rather than drug product imports, the Korean biosimilars giant has suggested, as it sought to assuage investor concerns over pharmaceutical tariffs announced by US president Donald Trump.
Biocon Biologics has announced a change in regulatory status for a manufacturing plant in Malaysia that could pave the way for a pair of long-awaited FDA biosimilar approvals, after similar positive news for an Indian site late last year.
Viatris has told investors it will incorporate any potential future financial impact into its soon-to-be-released 2025 guidance ranges, after the firm’s oral finished dose manufacturing facility in Indore, India, was slapped with a US Food and Drug Administration import alert and warning letter.
Aurobindo is looking to finally put a key manufacturing disruption behind it in Europe, enabling the firm to gain traction for some of its early biosimilar filings.
Attended by several government delegates, the opening of the multi-million dollar antibiotic plant highlighted the Indian government’s ongoing policy to bolster domestic pharmaceutical manufacturing.
Biocon Biologics chief commercial officer for advanced markets Matt Erick says the firm is a “quiet giant” in the biosimilars space, but speaks up about the firm’s plans to grow its business in Europe, explore in-licensing as well as in-house development, and capitalize on the upcoming loss of exclusivity for Stelara in the US.
Alkem and Torrent said the tested batches were not manufactured by them, as a recent CDSCO report pinned their drugs as “not of standard quality”. Meanwhile, other firms informed the agency themselves about counterfeit drugs on the market.
Amneal will lend its expertise in product development and manufacturing under a collaboration with obesity and metabolic disorders start-up Metsera – the latest in a recent string of deals involving the highly sought-after GLP-1 analogs.
The US FDA has issued a Form 483 to Granules India, with six observations, spanning document and vent mismanagement to bird droppings and rust.
Coherus BioSciences has warned that a supply interruption is coming for its Udenyca biosimilar pegfilgrastim rival to Neulasta in the US, after a CMO used for final packaging revealed capacity constraints.
Zydus Lifesciences must provide the US Food and Drug Administration with a detailed action plan addressing specific violations of current good manufacturing practice at its injectables site in Vadodara, Gujarat.