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A $31bn Opportunity? Future Of Biosimilars Inches Closer With Samsung Keytruda Study

Kick Off For Samsung Phase I Study Follows Recent Phase III News From Sandoz

 
• By Dean Rudge

Samsung Bioepis is among a small pool of players heading to the clinic for a proposed biosimilar to Merck & Co’s PD-1 mega-blockbuster, as interest and investment rises ahead of patent expiry at the end of the decade.

Samsung Bioepis has kicked off a Phase I clinical study for its SB27 biosimilar Keytruda (pembrolizumab) candidate, putting another player in the race to develop competition to the definitive immuno-oncology powerhouse that has been tipped to generate sales of $31bn by the time biosimilars roll around at the end of the current decade.

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More from Biosimilars

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 
• By Derrick Gingery

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

Henlius And Outlook Move Forward With Ophthalmic Bevacizumab

 
• By Dave Wallace

Henlius has reported progress in its development of a bevacizumab product for treating ophthalmic diseases, with its Essex-partnered HLX04-O candidate meeting its primary endpoint in a Phase III trial. Meanwhile, Outlook Therapeutics has taken another shot at getting its own ophthalmic bevacizumab approved in the US after resubmitting its filing.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

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

 
• By Urtė Fultinavičiūtė

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

More from Products

Spanish Authorities Investigate Sandoz Over Information-Sharing

 
• By Dave Wallace

Spanish competition regulator the CNMC has announced an investigation into Sandoz and its Bexal subsidiary – as well as Alliance Healthcare España and Bluetab Solutions – over sharing sensitive commercial information relating to pharmacy orders for generics.

Despite Multiple Headwinds, Formycon Remains Positive For Its Biosimilars Growth

 
• By Urtė Fultinavičiūtė

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

 
• By Dave Wallace

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.