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.

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.

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.

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.

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.

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.

The Bill & Melinda Gates Foundation has extended a financial commitment of up to $120m to secure a dedicated, low-cost supply of generic molnupiravir to lower-income countries. The Gates Foundation is looking to “significantly reduce the time it takes for a new drug to reach low-income countries after it becomes available in high-income markets.”

With multiple US biosimilar applications held up by the FDA’s inability to conduct necessary inspections in the context of the COVID-19 pandemic, the agency tells Generics Bulletin that it is “actively working” on a solution.

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.

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.

New Jersey-based Teligent reported a low quarter as the company continues to focus on remediation measures to lift the FDA warning letter hanging over its Buena New Jersey manufacturing facilty. Teligent has also recently recalled a batch of its 4% lidocaine hydrochloride topical solution because the firm’s testing found it to be super potent.

India’s Alkem has delivered a strong quarter with a boost in its domestic business on the back of “strong volume-led growth in the acute therapies and faster than market growth in chronic therapies.” However, the company saw a slight YoY decline in the US.

The US Association for Accessible Medicines has for the first time appointed two member-focused roles within its organization, as long-serving policy executive Christine Simmon was also handed a promotion.

Sandoz’s Rebecca Guntern has been named as interim president of Medicines for Europe for a three-month term, after Teva’s Christoph Stoller stepped down at the end of his two-year tenure.

Neuraxpharm has appoints Viatris’ head of finance in Germany as its new commercial central region officer and country manager to strengthen its position in the German market, while Stada has hired a new head of consumer health in Germany. Meanwhile, the AAM has made multiple key appointments and Hyloris, Siegfried and Mayne Pharma have made top-level additions.