First US Lucentis Biosimilar Expected By Year End, Roche Confirms

Samsung Bioepis’ SB11 Biosimilar Pending With FDA

Another of Roche’s biologic blockbusters is due to bite the dust this year, the originator has confirmed, with biosimilar competition to Lucentis forecast in the second half of 2021.

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Samsung Bioepis' SB11 candidate is pending approval with the USFDA • Source: Shutterstock

Roche has confirmed that the first biosimilar to its Lucentis (ranibizumab) eye-disease biologic is expected to launch in the US in the second half of 2021.

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Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
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While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Despite Multiple Headwinds, Formycon Remains Positive For Its Biosimilars Growth

 

Partnering opportunities, paused marketing, approvals, litigations, and many more. Formycon sets out the agenda for 2025, after seeing a bumpy start to the year.

Medicines For Europe Sets Out Vision For Biosimilars Reforms

 
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Four key areas for policy reform were identified by industry association Medicines for Europe at its biosimilars conference in early April, as sector chair Isabell Remus set out the importance of removing barriers to biosimilar competition.

Samsung Rolls Out Second US Soliris Biosimilar – At 30% WAC Discount

 
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Samsung Bioepis and Teva have provided clarity on the pricing of their Epysqli biosimilar to Soliris in the US, as the firms launched only the second rival to the rare diseases treatment.

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Samsung Rolls Out Second US Soliris Biosimilar – At 30% WAC Discount

 
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Samsung Bioepis and Teva have provided clarity on the pricing of their Epysqli biosimilar to Soliris in the US, as the firms launched only the second rival to the rare diseases treatment.

Biosimilars Industry Buoyed By EMA Paper On Reducing Clinical Trials

 
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The EMA’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam. Generics Bulletin discusses the new draft reflection paper and its significance for industry, reports on reactions from the event, and reveals the next steps unveiled by EMA officials.

Meitheal Adds To US Liraglutide List As It Looks To Ease Shortage Concerns

 
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Meitheal Pharmaceuticals said that its generic version of the GLP-1 agonist Victoza would be one of 22 planned launches during 2025, as the firm continues to build out its portfolio with the aid of its parent, Hong Kong King-Friend Industrial.