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Biosimilars Viability Debate Boils Up Between US Experts

 
• By Aidan Fry

The latest salvo has been fired in a fierce debate between US healthcare experts on whether US policymakers and payers should give up on biosimilars in favor of price controls on original biologics.

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A fierce debate over whether biosimilar competition can cut costs in the US is boiling up • Source: Shutterstock

Proponents of encouraging biosimilar competition in the US are depending on “flawed data” to support their arguments, according to the latest Health Affairs blog post for a group including leading oncologist Peter Bach that believes the US would be better served by regulating prices for original biologics after their period of market exclusivity.

In April this year, Bach ­– the director of Memorial Sloan Kettering’s Center for Health Policy and Outcomes – ­joined with his colleagues Preston Atteberry and Jennifer Ohn, as well...

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Teva Brings In European Trastuzumab With Prestige BioPharma Agreement

 
• By Dean Rudge

Teva will now market biosimilar Herceptin in both the US and Europe, after penning an agreement with Singaporean firm Prestige BioPharma for its Tuznue rival to the monoclonal antibody to treat HER2-positive breast cancer and HER2-positive metastatic stomach cancer.

SteinCares Deal Leads Lupin’s Ranibizumab Into Latin America

 
• By Dave Wallace

Lupin is planning to make inroads into the Latin American biosimilars market through a deal with local player SteinCares for a ranibizumab rival to Lucentis.

Hikma Gears Up To Enter US Biosimilars Market With Ustekinumab Nod

 
• By Dave Wallace

Hikma is set to make its first launch into the competitive US biosimilars market after its Bio-Thera-partnered Stelara rival, Starjemza, was approved by the FDA.

Regulatory Recap: ICH To Determine The Future Of Biosimilar Comparative Efficacy Studies

 
• By Urtė Fultinavičiūtė

Generics Bulletin reviews global regulatory developments across the world.

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Advanz Allies With Pharmathen On Long-Acting Injectable

 
• By Dave Wallace

Advanz Pharma has announced details of a fresh alliance on long-acting injectables with Pharmathen.

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.