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Biosim 'sweet spot' in Aust this year
Posted 30 January 2017
As the second biosimilar for AbbVie blockbuster Humira appeared on the ARTG last week, a leading lawyer and patent attorney predicted 2018 would see a sharp increase in local biosimilar registrations as patent expiries created a "sweet spot" for competition.
Naomi Pearce, Principal of Pearce IP and expert in pharma/biopharma patents, said while 2017 was a relatively quiet year for biosimilar activity, 2018 was set to heat up with numerous competitors poised to arrive on the ARTG before year's end.
"We are at a stage where the patent landscape for several biological products is mature and they are entering the final life-cycle of patent protection," she said.
Pearce said PBS-listed biologic blockbusters likely to see competitors registered on the ARTG this year included Roche's breast cancer blockbuster Herceptin and Amgen's Neulasta.
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Naomi Pearce
While Amgen also markets Neulasta as Ristempa with both brands listed on the PBS, Pearce predicts competitors will start to arrive in the next few months.
A Mylan/Biocon partnership refiled a previously withdrawn application for a competitor to Neulasta in Europe last November and, given many companies file in Australia at the same time as in Europe, Pearce tips a Neulasta biosimilar appearing on the ARTG by year's end.
Biosimilars were PBS-listed for both Enbrel and Remicade last year while Sandoz's Riximyo, a biosimilar of Roche's Mabthera, appeared on the ARTG in November along with Amgevita, Amgen's biosim of AbbVie's Humira.
Samsung Bioepis's Humira competitor Hadlima appeared on the ARTG last week in two doses while Pearce believes another Humira competitor, Boehringer Ingelheim's Cyltezo, will also appear on the ARTG this year after winning EU approval.
Together with partner MSD, Samsung Bioepis has also developed a Herceptin biosimilar, Ontruzant, which Pearce tips will appear on the ARTG in 2018 following its European approval in November.
The EMA is also currently considering applications from Amgen/Allergan and Mylan/Biocon for Herceptin competitors and Pearce predicts the three Herceptin biosimilars to already be contenders for TGA consideration.
"Australia generally follows about six months behind Europe," Pearce said. "These recent European developments are important and lead me to believe activity in Australia is very likely in 2018."
Pearce said the market-blocking patents on many of Australia's top-selling biologics had now expired, paving the way for competition to heat up in 2018.
"For most key targets, the key patents have expired or will expire by the end of next year," she said. "There will still be litigation around most of the products but with the blocking patents expired, we are looking at a sweet spot where biosimilars should be able to find a way through the patent landscape and enter the market."
However, she said originators were likely to continue to try and protect their turf with Roche filing an injunction against Sandoz in December, just three weeks after the generic company's Mabthera biosimilar was registered.
"All cases where the sponsor of the biologic has challenged a biosimilar competitor to date have settled, so we haven't yet had a proper debate," she said.
A case hearing for the Mabthera injunction is set down for next month.
Megan Brodie
Posted 30 January 2017
As the second biosimilar for AbbVie blockbuster Humira appeared on the ARTG last week, a leading lawyer and patent attorney predicted 2018 would see a sharp increase in local biosimilar registrations as patent expiries created a "sweet spot" for competition.
Naomi Pearce, Principal of Pearce IP and expert in pharma/biopharma patents, said while 2017 was a relatively quiet year for biosimilar activity, 2018 was set to heat up with numerous competitors poised to arrive on the ARTG before year's end.
"We are at a stage where the patent landscape for several biological products is mature and they are entering the final life-cycle of patent protection," she said.
Pearce said PBS-listed biologic blockbusters likely to see competitors registered on the ARTG this year included Roche's breast cancer blockbuster Herceptin and Amgen's Neulasta.
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| Naomi Pearce |
While Amgen also markets Neulasta as Ristempa with both brands listed on the PBS, Pearce predicts competitors will start to arrive in the next few months.
A Mylan/Biocon partnership refiled a previously withdrawn application for a competitor to Neulasta in Europe last November and, given many companies file in Australia at the same time as in Europe, Pearce tips a Neulasta biosimilar appearing on the ARTG by year's end.
Biosimilars were PBS-listed for both Enbrel and Remicade last year while Sandoz's Riximyo, a biosimilar of Roche's Mabthera, appeared on the ARTG in November along with Amgevita, Amgen's biosim of AbbVie's Humira.
Samsung Bioepis's Humira competitor Hadlima appeared on the ARTG last week in two doses while Pearce believes another Humira competitor, Boehringer Ingelheim's Cyltezo, will also appear on the ARTG this year after winning EU approval.
Together with partner MSD, Samsung Bioepis has also developed a Herceptin biosimilar, Ontruzant, which Pearce tips will appear on the ARTG in 2018 following its European approval in November.
The EMA is also currently considering applications from Amgen/Allergan and Mylan/Biocon for Herceptin competitors and Pearce predicts the three Herceptin biosimilars to already be contenders for TGA consideration.
"Australia generally follows about six months behind Europe," Pearce said. "These recent European developments are important and lead me to believe activity in Australia is very likely in 2018."
Pearce said the market-blocking patents on many of Australia's top-selling biologics had now expired, paving the way for competition to heat up in 2018.
"For most key targets, the key patents have expired or will expire by the end of next year," she said. "There will still be litigation around most of the products but with the blocking patents expired, we are looking at a sweet spot where biosimilars should be able to find a way through the patent landscape and enter the market."
However, she said originators were likely to continue to try and protect their turf with Roche filing an injunction against Sandoz in December, just three weeks after the generic company's Mabthera biosimilar was registered.
"All cases where the sponsor of the biologic has challenged a biosimilar competitor to date have settled, so we haven't yet had a proper debate," she said.
A case hearing for the Mabthera injunction is set down for next month.
Megan Brodie
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