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

 
• By Ian Schofield

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...

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EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
• By Eliza Slawther and Neena Brizmohun

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

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

 
• By Neena Brizmohun

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

 
• By Eliza Slawther

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.

More from Biosimilars & Generics

‘Prescription Drugs Are Not Golf Balls’: FTC/DoJ Solicit Clashing Opinions On Patents

 
• By Urtė Fultinavičiūtė

Innovator drug advocates argued that the number of patents asserted by industry is not too dissimilar to other fields. But should drugs be compared to golf balls?

ANDA User Fees: Complex Generics, Transparency, Communications Are Early Negotiation Targets

 
• By Sue Sutter

Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.

US FDA Will Not Pull Teva And MSN Hetlioz ANDAs, Rejects Vanda Citizen Petitions

 
• By Dean Rudge

The FDA concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements and there was no “mistake” or untrue statement in the original ANDA approvals.