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What’s Next? Five Things To Look Out For In January

Alvotech Waits On Pivotal FDA Inspection; JP Morgan Conference Hits San Francisco

 
• By Dean Rudge

Generics Bulletin previews the most noteworthy and anticipated events for January 2024.

What's Next Image

Alvotech is set to face a long-awaited US Food and Drug Administration reinspection of its Reykjavik facility in January, in a key milestone for the Icelandic firm that could pave the way finally to a US approval for its Teva-partnered AVT02 adalimumab high-concentration interchangeable biosimilar to Humira.

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More from Manufacturing

As US Launches Pharma Probe, AAM Warns Tariffs ‘Will Only Amplify Problems’

 
• By Dave Wallace

News of a fresh US investigation into the pharma sector has sparked renewed concerns over the impact that US trade tariffs would have on the generics and biosimilars industry. The AAM has responded with a warning over the potential effects on shortages and access, while Medicines for Europe has proposed five key action areas to bolster the sector in Europe.

Who’s Hired? Alvotech Appoints Strategy And Quality Chiefs

 
• By Dave Wallace

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.

Sandoz And Delpharm Renew Canadian Injectables Supply Agreement For 10 Years

 
• By Dean Rudge

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 Teams Up With Civica On US Insulin Production

 
• By Dave Wallace

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.

More from Business

Sandoz Attacks Amgen Over US Enbrel Exclusivity

 
• By Dave Wallace

Having failed in US patent litigation over Amgen’s Enbrel, Sandoz is taking an alternative approach in trying to get its Erelzi biosimilar to market in the US ahead of patent expiry in 2029: launching an antitrust attack against the originator for “unlawfully extending and entrenching its monopoly."

Cipla Welcomes Abraxane ANDA Approval After Tackling Goa Compliance Issues

 
• By Dean Rudge

Cipla will look to give its US operations a boost later this year by launching only the second Abraxane ANDA product.

Emcure’s Subsidiary Tillomed Boosts Portfolio With $20m+ Manx Deal

 
• By Adam Zamecnik

The company did not disclose which particular drugs it secured through the deal that further boosted its portfolio that already includes more than 100 assets.