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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.

The Korean firm’s study will compare the pharmacokinetics, efficacy, safety, and immunogenicity of SB27 versus EU-sourced and US-sourced Keytruda, in patients with stage II-IIIA non-small cell lung cancer

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More from Biosimilars

Aurobindo Racks Up Another Biosimilar Nod With Filgrastim In UK

 
• By Dave Wallace

Aurobindo’s run of biosimilar registration successes continues, with the firm’s CuraTeQ subsidiary picking up approval for its Zefylti version of filgrastim in the UK.

J&J Hits Back Over Private-Label Stelara Biosimilar In US

 
• By Dave Wallace

After being refused an injunction as part of ongoing litigation over a private-label ustekinumab biosimilar being marketed in the US by Sandoz and Samsung Bioepis, Stelara originator Johnson & Johnson is continuing to pursue an appeal. However, newly-unsealed court documents suggest the brand company had demonstrated a likelihood of success - and reveal further details about the case, including the identity of the PBM involved and why the injunction request was denied.

Amgen Locked Out Of Canadian Eculizumab Market Until 2027

 
• By Dean Rudge

Rejecting Amgen’s challenges on the grounds of anticipation and obviousness, Canada’s Federal Court has issued an injunction against the biosimilars firm until patent expiry in March 2027.

‘We Can’t Keep Going On Like This’ – Biosimilars Forum’s Reed Calls For Urgent Changes In US

 
• By Dave Wallace

As the US biosimilars market moves into its second decade, urgent changes are needed at the FDA if biosimilars are to meet their full potential, according to Biosimilars Forum chief executive Julie Reed.

More from Products

Hikma Eyes $5bn Sales Target As It Sets Out Plans To 2030

 
• By Dave Wallace

Unveiling a new name for its generics business, Hikma has at the same time set out medium-term financial goals for its business that include three-year growth objectives for its sales and profits, as well as aiming at a $5bn turnover target by 2030.

Cipla Leadership’s Early Take On Trump’s Pricing EO And Pipeline Progress

 
• By Anju Ghangurde

Cipla's CEO underlines that US generic prices are already “very significantly comparable” with the rest of the world and expects President Donald Trump's executive order on drug pricing to primarily impact branded pharmaceuticals. The company also shared updates on its US pipeline.

Gedeon Richter: General Medicines Unit Deserves ‘More Attention And Credit’

 
• By Dean Rudge

Gedeon Richter’s CEO has urged analysts and the firm itself to give more attention to its “unfairly neglected” General Medicines division – which includes both generics and licensed-in innovative products – during the Hungarian firm’s first-quarter earnings call.