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Humira competitors fall away
Posted 30 November 2018
The local biosimilar market for AbbVie's Humira has been left empty after another competitor for the therapy drops out of the race.
Boehringer Ingelheim has announced it will abandon development of its biosimilars outside the US, including its Humira biosimilar Cyltezo.
"At this point in time, future biosimilar activities will be driven out of the US market... while BI is stopping development activities for the rest of the world," a BI spokesperson told US publication BioProcess.
The announcement comes after both Amgen and MSD said they would not be proceeding with PBS listing of their biosimilars Amgevita and Hadlima despite the July meeting of the PBAC recommending the copies.
In September 2017, Amgen made a deal with AbbVie delaying the launch of Amgevita in certain jurisdictions. This included a delay until 2023 for the US and until late 2018 for Europe, while the Australian date was not disclosed.
Samsung Bioepis, which manufactures MSD's Hadlima, also made a similar deal with AbbVie in April.
Meanwhile Mylan reached an agreement in July for its Humira biosimilar and Novartis' Sandoz did so just last month.
Currently BI is one major Humira biosimilar player which has yet to reach a resolution with AbbVie in ongoing US patent litigation. However, should the company succeed in defending its biosimilar, its results would not affect Australia given the company's withdrawal of launches outside of the US.
It means it is uncertain when there will be a PBS-listed biosimilar for the blockbuster, preserving its $316 million pre-rebate R/PBS benefits market.
Amgevita's PBAC public summary document revealed the expected PBS listing of a biosimilar would incur savings of $30 to $60 million per year in the first six years - without accounting for price disclosure cuts.
"This would increase to more than $100 million by year six if price disclosure cuts are realised," it said, adding the listing would most likely also remove SPA agreements for Humira.
"The sponsor estimated the rebate to be 28 per cent, based on the revealed rebate when [Pfizer's] Enbrel moved from F1 to F2," it said.
Yajun Ma
Posted 30 November 2018
The local biosimilar market for AbbVie's Humira has been left empty after another competitor for the therapy drops out of the race.
Boehringer Ingelheim has announced it will abandon development of its biosimilars outside the US, including its Humira biosimilar Cyltezo.
"At this point in time, future biosimilar activities will be driven out of the US market... while BI is stopping development activities for the rest of the world," a BI spokesperson told US publication BioProcess.
The announcement comes after both Amgen and MSD said they would not be proceeding with PBS listing of their biosimilars Amgevita and Hadlima despite the July meeting of the PBAC recommending the copies.
In September 2017, Amgen made a deal with AbbVie delaying the launch of Amgevita in certain jurisdictions. This included a delay until 2023 for the US and until late 2018 for Europe, while the Australian date was not disclosed.
Samsung Bioepis, which manufactures MSD's Hadlima, also made a similar deal with AbbVie in April.
Meanwhile Mylan reached an agreement in July for its Humira biosimilar and Novartis' Sandoz did so just last month.
Currently BI is one major Humira biosimilar player which has yet to reach a resolution with AbbVie in ongoing US patent litigation. However, should the company succeed in defending its biosimilar, its results would not affect Australia given the company's withdrawal of launches outside of the US.
It means it is uncertain when there will be a PBS-listed biosimilar for the blockbuster, preserving its $316 million pre-rebate R/PBS benefits market.
Amgevita's PBAC public summary document revealed the expected PBS listing of a biosimilar would incur savings of $30 to $60 million per year in the first six years - without accounting for price disclosure cuts.
"This would increase to more than $100 million by year six if price disclosure cuts are realised," it said, adding the listing would most likely also remove SPA agreements for Humira.
"The sponsor estimated the rebate to be 28 per cent, based on the revealed rebate when [Pfizer's] Enbrel moved from F1 to F2," it said.
Yajun Ma
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