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AbbVie hit with first Humira copy
Posted 10 November 2017
AbbVie's Humira (adalimumab) could be facing the end of its market exclusivity after Amgen registered a biosimilar of the blockbuster drug on the ARTG.
Amgen's Amjevita has successively made its way through the US and EU regulatory authorities, becoming the first approved biosimilar for Humira in both jurisdictions, and has now landed in Australia with an ARTG registration just yesterday.
Humira is one of the biggest drugs listed on the PBS. It earned AbbVie pre-rebate R/PBS benefits of $314.8 million in year to September 2017, around 79 per cent of the company's total pre-rebate earnings in that period. It represents around 60 per cent of AbbVie's global sales.
AbbVie has been preparing for the drug's loss of exclusivity, launching online educational courses for pharmacists and attempting - though failing - to extend its patent for certain indications added later to the ARTG.
However its initiatives are unlikely to soften the blow that new competition will inflict on the sales of the biologic.
The company's global Q2 results showed the company expected its revenue to be impacted by biosimilar competition for the drug.
Aside from Amjevita, other Humira biosimilars are also looking to take a share of the drug's considerable market, including BI's Cyltezo, approved by the FDA in August and given CHMP recommendation in September.
Recently the PBAC said it would have no problem if biosimilars were given preference in prescribing software and this uptake driver is expected to be given effect in next month's PBS update.
Yajun Ma
yajun.ma@lushmedia.com.au
Posted 10 November 2017
AbbVie's Humira (adalimumab) could be facing the end of its market exclusivity after Amgen registered a biosimilar of the blockbuster drug on the ARTG.
Amgen's Amjevita has successively made its way through the US and EU regulatory authorities, becoming the first approved biosimilar for Humira in both jurisdictions, and has now landed in Australia with an ARTG registration just yesterday.
Humira is one of the biggest drugs listed on the PBS. It earned AbbVie pre-rebate R/PBS benefits of $314.8 million in year to September 2017, around 79 per cent of the company's total pre-rebate earnings in that period. It represents around 60 per cent of AbbVie's global sales.
AbbVie has been preparing for the drug's loss of exclusivity, launching online educational courses for pharmacists and attempting - though failing - to extend its patent for certain indications added later to the ARTG.
However its initiatives are unlikely to soften the blow that new competition will inflict on the sales of the biologic.
The company's global Q2 results showed the company expected its revenue to be impacted by biosimilar competition for the drug.
Aside from Amjevita, other Humira biosimilars are also looking to take a share of the drug's considerable market, including BI's Cyltezo, approved by the FDA in August and given CHMP recommendation in September.
Recently the PBAC said it would have no problem if biosimilars were given preference in prescribing software and this uptake driver is expected to be given effect in next month's PBS update.
Yajun Ma
yajun.ma@lushmedia.com.au
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