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Mylan biosim boom targets Aust
Pharma in Focus this week sat down with Mylan country manager and GBMA chairman Sylvain Vigneault. This is the first of a three-part series covering issues such as Mylan's planned drug launches, generics revenue in Australia and the need to ensure PBS sustainability.
Posted 5 July 2018
After three years at the helm of Mylan Australian, country manager Sylvain Vigneault says he is here to stay. The French Canadian national has local residency and says Australia is now home - and he intends to keep it that way.
After six years in the country (three years as Abbott general manager), Vigneault says the lifestyle suits him, even if our short winters are a little too chilly for his liking.
The natural athlete who enjoys running, mountain and road cycling isn't too keen on getting up early on a cold Sydney morning but says the challenge of leading a company that continues to register double-digit growth on an annual basis and offers a broad portfolio is one he relishes.
With around 250 products listed on the PBS - the "vast majority of them molecules" - yet with a range of innovative products and a train of biosimilars coming through, Vigneault says the company's broad portfolio is what ensures its sustainability.
"The broad base that we have with the proprietary, the OTC and all the biologics is part of a mix which helps sustainability," he said.
"One of the strengths that Mylan brings... is that it is very strongly integrated vertically as well, producing 80 per cent of its own active pharmaceutical ingredients."
"The intention is to have every product we have developed, or collaborated in developing, brought to the market." Sylvain Vigneault
This manufacturing strength provides the backbone for Mylan to bring its biosimilars to market, the first of which is before the PBAC this week.
Globally Mylan has 7,500 products marketed across 165 countries and boasts that no single product generates more than four per cent of total revenue - something which Vigneault says is also true in Australia.
The net worth of the generics giant is estimated at $327 billion, almost a third of which is attributed to its biosimilars.
Speaking at an Investor Day in April, Mylan president Rajiv Malik said the company had been "diligent" in selecting its biosimilar portfolio, which includes copies of blockbuster biologics Neulasta, Herceptin, Humira, Avastin, Neupogen, Enbrel and Perjeta along with insulin biosim Semglee, a copy of Lantus.
Its Herceptin biosimilar Ogivri cracked the US in December, the company's first biosimilar approved by the FDA, and was followed by its Neulasta biosim Fulphila last month.
Mylan is following its US applications closely with Australian filings; success at PBAC this week would see Fulphila launched as the company's first Australian biosim.
Malik described the Mylan business model as market-driven.
"Market comes first," he said. "If we don't have a product and the market needs it, we'll go and find it."
Vigneault said this was also true for Australia, with the company's desire to bring its full portfolio of biosimilars here guided by factors such as market need, reimbursement potential and patent opportunity.
"The intention is to have every product we have developed, or collaborated in developing, brought to the market but you have to do the proper assessment first," Vigneault said.
Megan Brodie
Pharma in Focus this week sat down with Mylan country manager and GBMA chairman Sylvain Vigneault. This is the first of a three-part series covering issues such as Mylan's planned drug launches, generics revenue in Australia and the need to ensure PBS sustainability.
Posted 5 July 2018
After three years at the helm of Mylan Australian, country manager Sylvain Vigneault says he is here to stay. The French Canadian national has local residency and says Australia is now home - and he intends to keep it that way.
After six years in the country (three years as Abbott general manager), Vigneault says the lifestyle suits him, even if our short winters are a little too chilly for his liking.
The natural athlete who enjoys running, mountain and road cycling isn't too keen on getting up early on a cold Sydney morning but says the challenge of leading a company that continues to register double-digit growth on an annual basis and offers a broad portfolio is one he relishes.
With around 250 products listed on the PBS - the "vast majority of them molecules" - yet with a range of innovative products and a train of biosimilars coming through, Vigneault says the company's broad portfolio is what ensures its sustainability.
"The broad base that we have with the proprietary, the OTC and all the biologics is part of a mix which helps sustainability," he said.
"One of the strengths that Mylan brings... is that it is very strongly integrated vertically as well, producing 80 per cent of its own active pharmaceutical ingredients."
"The intention is to have every product we have developed, or collaborated in developing, brought to the market." Sylvain Vigneault
This manufacturing strength provides the backbone for Mylan to bring its biosimilars to market, the first of which is before the PBAC this week.
Globally Mylan has 7,500 products marketed across 165 countries and boasts that no single product generates more than four per cent of total revenue - something which Vigneault says is also true in Australia.
The net worth of the generics giant is estimated at $327 billion, almost a third of which is attributed to its biosimilars.
Speaking at an Investor Day in April, Mylan president Rajiv Malik said the company had been "diligent" in selecting its biosimilar portfolio, which includes copies of blockbuster biologics Neulasta, Herceptin, Humira, Avastin, Neupogen, Enbrel and Perjeta along with insulin biosim Semglee, a copy of Lantus.
Its Herceptin biosimilar Ogivri cracked the US in December, the company's first biosimilar approved by the FDA, and was followed by its Neulasta biosim Fulphila last month.
Mylan is following its US applications closely with Australian filings; success at PBAC this week would see Fulphila launched as the company's first Australian biosim.
Malik described the Mylan business model as market-driven.
"Market comes first," he said. "If we don't have a product and the market needs it, we'll go and find it."
Vigneault said this was also true for Australia, with the company's desire to bring its full portfolio of biosimilars here guided by factors such as market need, reimbursement potential and patent opportunity.
"The intention is to have every product we have developed, or collaborated in developing, brought to the market but you have to do the proper assessment first," Vigneault said.
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