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Strategy

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Roche Makes Tocilizumab Launch Prediction As Biosimilars Progress

Roche gave small insight into its expectations around biosimilar competition for its Actemra/RoActemra (tocilizumab) treatment for inflammatory diseases. Extraordinary demand for the biologic led sales to skyrocket by 143% in the third quarter and caused supply constraints for the originator.

Biosimilars Market Access

180 Life Sciences’ Woody Sets Out Vision For Repurposing Anti-TNF Biologics

After 180 Life Sciences recently struck a deal with Korea’s Celltrion to support its work in repurposing off-patent biologics, CEO Jim Woody speaks to Generics Bulletin about what the collaboration means for the company and its next steps.

Deals Strategy

Hyloris Prepares For UK And Ireland Maxigesic IV Launch

Value-added medicines specialist Hyloris has announced launch plans for its Maxigesic IV analgesic in the UK and Ireland after receiving approvals for the intravenous paracetamol/ibuprofen solution. The nods follow two deals aimed at bolstering the firm’s pipeline.

Approvals Deals

Sawai Cites Broader Supply Issue As It Plots Construction Of A New Facility

Japan’s Sawai was cautioned by one analyst earlier this year that it lacked sufficient excess production capacity to handle the sharp expansion in demand for its products. Now the company has announced plans to build a new solid dosage form facility.

Manufacturing Strategy

Phlow Seeks To Build On Fresenius Kabi Collaboration

US-based Phlow and Fresenius Kabi have announced an alliance to supply essential medicines, including injectables, for public health emergencies and to Children’s Hospital Coalition, a project by Phlow. In an exclusive interview with Generics Bulletin, Phlow chief business officer Dan Hackman talks about the partnership, addressing US supply chain disruptions, domestic manufacturing and more.

United States Deals

Dr Reddy’s Eyes Generic Revlimid Exclusivity With ANDA Approval

With Natco poised to debut the first batch of Revlimid generics in the US in March next year, fellow Indian ANDA sponsor Dr Reddy’s Laboratories has secured its own approval from the FDA for two strengths of the blockbuster multiple myeloma treatment.

Generic Drugs Approvals

First Interchangeable Humira Biosimilar Approved In US

Boehringer Ingelheim has won a landmark first US interchangeability designation for a biosimilar to Humira, with the firm’s Cyltezo version of adalimumab representing the second ever interchangeable biosimilar approved by the FDA.

Biosimilars Approvals

Troubled Teligent Enters Bankruptcy Proceedings As CEO Resigns

Teligent is pursuing an asset sale process to “maximize the value of the company” after entering into Chapter 11 bankruptcy proceedings in the US. The firm – which has also seen CEO Tim Sawyer resign – had been struggling of late with remediation issues to address a warning letter at its Buena manufacturing facility in New Jersey, as well as a recent recall.

Legal Issues Deals

Generics Bulletin Editor’s Picks For Q3 2021

Looking back over a busy third quarter in 2021, Generics Bulletin executive editor David Wallace picks out highlights from July to September that include major legal and regulatory developments, multiple firsts in the biosimilars arena, significant M&A activity and our annual ranking of the off-patent sector’s top 50 companies.

Generic Drugs Biosimilars
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