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End nears for Humira, Lantus
Posted 20 August 2018
Two longstanding giants of the PBS, AbbVie's Humira and Sanofi's Lantus, are set to lose exclusivity following the PBAC's decision to back biosimilar competition for both.
The combined top-line PBS value of the two brands for the 12 months to June 30 this year was $460 million.
Each represents the majority of pre-rebate PBS receipts for their sponsors, specifically: 80 per cent for AbbVie with Humira earning $316.4 million, and 49 per cent for Sanofi with Lantus earning $143.7 million. No other drugs in the companies' portfolios come close.
The PBAC backed two submissions for Humira competitors, Amgen's Amgevita and MSD's Hadlima as well as recommending Mylan's Lantus biosimilar Semglee.
Amgevita has been recommended for reimbursement in all of Humira's indications but Hadlima has been recommended only in rheumatoid arthritis, the sole indication for which it is TGA approved. The PBAC has called for uptake drivers to be applied to both drugs, meaning they will enjoy a less restrictive authority regime than Humira.
Semglee is set to be listed as an "unrestricted benefit listing for... all indications for which the reference biologic is currently PBS listed". The PBAC set aside concern about different injection devices, saying any differences "could be safely managed by health care professionals in the course of regular patient education and counselling".
The entry of Semglee onto the PBS will end a three-year reprieve from competition for Lantus after potential rival Basaglar was held back from listing by sponsor Eli Lilly despite a positive PBAC recommendation in 2015.
The Semglee decision also brings generics giant Mylan - under its Alphapharm moniker - into the Australian biosimilar market for the first time and means the Generics and Biosimilar Medicines Association at last has a big biosim player among its ranks.
Mylan had hoped to get two biosimilars up, also submitting Fulphila, for which the reference drug is Amgen's Neulasta, but the PBAC deferred making a decision pending TGA approval of the competitor.
July PBAC outcomes also show that Sanofi lost out twice, as well as seeing a Lantus biosim recommended, it failed to win the PBAC's nod for listing of new eczema biological Dupixent in severe atopic dermatitis due to "uncertainty regarding the appropriate place in therapy and uncertain cost effectiveness".
The committee said it did not consider that the data supported restricting use of dupilumab only to severe disease. The drug is widely considered vital to Sanofi regaining ground certain to be lost when Lantus loses its monopoly status.
Nick Lush
Posted 20 August 2018
Two longstanding giants of the PBS, AbbVie's Humira and Sanofi's Lantus, are set to lose exclusivity following the PBAC's decision to back biosimilar competition for both.
The combined top-line PBS value of the two brands for the 12 months to June 30 this year was $460 million.
Each represents the majority of pre-rebate PBS receipts for their sponsors, specifically: 80 per cent for AbbVie with Humira earning $316.4 million, and 49 per cent for Sanofi with Lantus earning $143.7 million. No other drugs in the companies' portfolios come close.
The PBAC backed two submissions for Humira competitors, Amgen's Amgevita and MSD's Hadlima as well as recommending Mylan's Lantus biosimilar Semglee.
Amgevita has been recommended for reimbursement in all of Humira's indications but Hadlima has been recommended only in rheumatoid arthritis, the sole indication for which it is TGA approved. The PBAC has called for uptake drivers to be applied to both drugs, meaning they will enjoy a less restrictive authority regime than Humira.
Semglee is set to be listed as an "unrestricted benefit listing for... all indications for which the reference biologic is currently PBS listed". The PBAC set aside concern about different injection devices, saying any differences "could be safely managed by health care professionals in the course of regular patient education and counselling".
The entry of Semglee onto the PBS will end a three-year reprieve from competition for Lantus after potential rival Basaglar was held back from listing by sponsor Eli Lilly despite a positive PBAC recommendation in 2015.
The Semglee decision also brings generics giant Mylan - under its Alphapharm moniker - into the Australian biosimilar market for the first time and means the Generics and Biosimilar Medicines Association at last has a big biosim player among its ranks.
Mylan had hoped to get two biosimilars up, also submitting Fulphila, for which the reference drug is Amgen's Neulasta, but the PBAC deferred making a decision pending TGA approval of the competitor.
July PBAC outcomes also show that Sanofi lost out twice, as well as seeing a Lantus biosim recommended, it failed to win the PBAC's nod for listing of new eczema biological Dupixent in severe atopic dermatitis due to "uncertainty regarding the appropriate place in therapy and uncertain cost effectiveness".
The committee said it did not consider that the data supported restricting use of dupilumab only to severe disease. The drug is widely considered vital to Sanofi regaining ground certain to be lost when Lantus loses its monopoly status.
Nick Lush
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