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.

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.”

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.

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.

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.

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.

A European Medicines Agency pilot scheme offering tailored scientific advice on biosimilar development has been viewed by applicants as a “valuable opportunity” and the process will continue as part of regular operations, according to an agency report.

Generic and biosimilar medicines must become central to European healthcare policy as the region looks to rebuild in the wake of the COVID-19 pandemic, Medicines for Europe’s new president, Rebecca Guntern of Sandoz, tells Generics Bulletin in an exclusive interview.

A continuing lack of legal certainty continues to plague suppliers to the Northern Ireland market despite the latest proposals from the EU Commission, UK and European off-patent industry leaders Mark Samuels and Adrian van den Hoven tell Generics Bulletin.

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.

French off-patent association Gemme has hit back after the country’s latest annual PLFSS social security legislation contained a lack of measures to boost generics and biosimilars. Three key policy proposals have been outlined by the industry body.

As Boehringer Ingelheim’s Cyltezo has become the second-ever interchangeable biosimilar approved by the US FDA – as well as the first monoclonal antibody to garner the designation and offering the first published data from a switching trial to support interchangeability – the debate around the potential impact for interchangeable products in the keenly-watched adalimumab space and beyond continues to grow.

Generic and biosimilar medicines must become central to European healthcare policy as the region looks to rebuild in the wake of the COVID-19 pandemic, Medicines for Europe’s new president, Rebecca Guntern of Sandoz, tells Generics Bulletin in an exclusive interview.

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.”

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.

A European Medicines Agency pilot scheme offering tailored scientific advice on biosimilar development has been viewed by applicants as a “valuable opportunity” and the process will continue as part of regular operations, according to an agency report.

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.

Generic and biosimilar medicines must become central to European healthcare policy as the region looks to rebuild in the wake of the COVID-19 pandemic, Medicines for Europe’s new president, Rebecca Guntern of Sandoz, tells Generics Bulletin in an exclusive interview.

Adamis has announced receiving FDA approval for Zimhi, its high-dose naloxone hydrochloride for injection, indicated for the treatment of opioid overdose. The company has partnered with US WorldMeds to market Zimhi by the first quarter of 2022. 

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.

Glenmark is celebrating the approval of its Ryaltris nasal spray in 13 European countries, with the Indian company and partner Menarini set to begin rolling out the allergic rhinitis combination product.