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Coherus Biosimilar Used ‘Scientific Justification’ To Skip Switch Study, Still Get Interchangeability With Lucentis

 
• By Sue Sutter

Information on mechanism of action, pharmacokinetics, immunogenicity and toxicity convinced the US FDA there was no risk in terms of safety or diminished efficacy of switching between Cimerli and the reference product, Genentech’s eye drug Lucentis.

Eye data binary
Cimerli was not subject to a 'switching' study prior to earning an interchangeability nod • Source: Shutterstock

Coherus BioSciences and partner Bioeq provided “sufficient justification” that Cimerli (ranibizumab-eqrn), a biosimilar of Genentech’s macular degeneration treatment Lucentis (ranibizumab), will produce the same clinical result in any given patient for each condition of use, the US Food and Drug Administration said in deciding to award an interchangeability designation in the absence of a “switching” study.

This scientific justification took into account information on mechanism of action, pharmacokinetics, immunogenicity and toxicity, the FDA said in a multidisciplinary review memo.

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Samsung Bioepis Heads For Spin Out To Unlock ‘Hidden Value’

 
• By Dean Rudge

Samsung Biologics will retain solely its significant CDMO business, eliminating a perceived conflict of interest, as it pursues an equity spin-off for its biosimilars business Samsung Bioepis.

Amgen And Samsung Soliris Biosimilars Skirt UK Infringement On Claim Construction

 
• By Dean Rudge

Just days after a court in Canada barred Amgen’s Soliris biosimilar until patent expiry in 2027, a UK High Court has handed a favorable ruling to the California-based firm and Samsung Bioepis, ruling that their products do not infringe a patent shielding the branded treatment for paroxysmal nocturnal hemoglobinuria.

Formycon Hopes Stelara Biosimilar Sales To Pull Through FY2025 As Q1 Revenues Slump

 
• By Urtė Fultinavičiūtė

Formycon said it predicted low earnings in the first quarter of 2025, after enjoying milestone payments last year. Now, the pressure is on the growing biosimilars portfolio to pull the company through this year.

Gedeon Richter Feels Biosimilar Model ‘Is Looking For An Equilibrium’

 
• By Dean Rudge

Gedeon Richter’s CEO weighed in on the pricing landscape for biosimilars as the firm admitted the market for biosimilar denosumab was set to be more crowded than it had initially anticipated.

More from Products

ANI Raises Generics Guidance As Exclusive Prucalopride Drives Growth

 
• By Dean Rudge

ANI Pharmaceuticals says it has delivered an “exceptionally strong first quarter,” with total sales reaching over $197m, amid plans to kick off a Phase IV clinical trial for Cortrophin Gel for acute gouty arthritis later this year.

Aurobindo, MSN Fall To US Nuplazid Patent Expiring In August 2038

 
• By Dean Rudge

Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis is looking safe from generic competition – for now – until well into the next decade, following a favorable infringement and validity decision by a US district court.

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.