Samsung Bioepis’s Biosimilar Enbrel ‘Substitutable’ In Australia As Pfizer Patent Case Is Rebuffed

Samsung Bioepis’s Brenzys has become the second biosimilar product to be reimbursed as substitutable at the pharmacy level in Australia, and a court has scotched Pfizer’s plans to initiate a patent infringement claim over the manufacturing process for the Enbrel/etanercept biosimilar.

Magnifying glass focusing on Australia
Biosimilar etanercept is the latest biosimilar to be substitutable in Australia

Samsung Bioepis Co. Ltd./Merck Sharp & Dohme Australia’s biosimilar etanercept product, Brenzys, a version of Amgen Inc./Pfizer Inc.’s anti-TNF Enbrel, has been made available under the Australian Pharmaceutical Benefits Scheme as a drug that can be substituted at pharmacy level for the originator.

Meanwhile, in another plus for Samsung Bioepis, an Australian court has denied Pfizer’s application for the disclosure of documents on...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Biosimilars

EU Biosimilar Filings, Opinions And Approvals

 

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.

EU Decision Time For Madrigal’s MASH Drug Resmetirom And 11 Others

 

Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.

US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 

FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.

More from Biosimilars & Generics

US Supreme Court Wants Solicitor General Input On Hikma Skinny Label Case

 
• By 

The US Supreme Court is seeking the administration's view following the Federal Circuit decided to reopen Amarin’s case against the ‘skinny-label’ generic Vascepa (icosapent ethyl).

Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 

Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.