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Biosimilars

Set Alert for Biosimilars

EMA Moves Ahead With Tailored Scientific Advice For Biosimilars

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.

Biosimilars Europe

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

Central Role For Industry Beckons As Europe Rebuilds After COVID

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.

Policy Regulation

Viatris’ Interchangeable Semglee Lands On Express Scripts Formulary

Months after obtaining the first US FDA designation of interchangeability, for its Semglee biosimilar to Sanofi’s Lantus, Viatris has seen a return on its investment, with the biosimilar scooping preferred status on one of the largest national formularies in the US.

Biosimilars Commercial

Roche Feels Lucentis Market Could Move On Before Biosimilars Debut

Roche upended expectations for biosimilar Lucentis (ranibizumab) in the US, with a recent licensing deal signed with biosimilar sponsor Samsung Bioepis keeping the first proposed rival from the market until June 2022. The originator is also confident its pipeline assets will stem competition.

Biosimilars Commercial

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

Sandoz Partner Gan & Lee Wraps Phase III Insulin Glargine Trial

Sandoz’ partnership with China’s Gan & Lee covering three biosimilar insulin products continues to make progress, with the conclusion of a pair of Phase III trials involving a proposed biosimilar to Lantus (insulin glargine).

Biosimilars Clinical Trials

FDA Will Take Action On Biosimilars Delayed By Inspection Lag

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.

Biosimilars FDA

France’s Gemme Pushes Back Against Lack Of Government Action

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.

Policy France
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