ยาใหม่ 11 ตัวที่จะเปิดตัวปี 2015 ที่ต่างประเทศ ที่น่าจับตามองครับ
ปี 2015 นี้ในต่างประเทศมียาหลายตัวที่เป็นที่จับตามองนะครับ ตัวไหนกลุ่มไหนบ้างมาลองดูครับ
แต่กว่าจะเข้าเมืองไทยคงสักระยะครับ
1. Opdivo/nivolumab (Bristol-Myers Squibb)
Company: Bristol-Myers Squibb
Pharmaceutical class/therapeutic area: Cancer/anti-PD-1 monoclonal antibody
Current regulatory status: Filed for approval in U.S., EU
คาดการณ์ยอดขายในปี 2015 sales: $658 million
คาดการณ์ยอดขายในปี2020 sales: $7.122 billion
What to watch: Opdivo is projected to be the biggest new drug launch in the U.S. and one of the
biggest launches worldwide this decade. It became the first approved anti-PD-1 medication when it
was cleared in Japan and has shown promise in treating Hodgkin's lymphoma on top of multiple
myeloma (and is being tested on many other cancers). But the really good news for BMS is that
Opdivo has produced a better response rate in trials than Merck's competing (and historic) PD-1
inhibitor Keytruda (pembrolizumab). If that trend continues, then BMS could rule this exciting new
therapeutic class. The FDA is expected to decide on Opdivo approval by March.
2. Alirocumab (Sanofi/Regeneron)
Company: Sanofi/Regeneron
Pharmaceutical class/therapeutic area: LDL cholesterol reducer/anti-PCSK9 monoclonal antibody
Current regulatory status: Phase III trials
คาดการณ์ยอดขายในปี 2015 sales: $44 million
คาดการณ์ยอดขายในปี 2020 sales: $2.179 billion
What to watch: PCSK9 inhibitors, besides anti-PD-1 drugs, are the most exciting new therapeutic
class to come out of the woodwork in recent times. What makes these LDL-lowering drugs
particularly exciting is the timing of their filings, with doctors' groups in the U.S. and EU having
recently endorsed controversial new guidelines that significantly expand the use of statins. If that
course of action proves too risky, and PCSK9 drugs like alirocumab aren't prohibitively pricey, these
could become the go-to option in an absolutely critical field.
3. Evolocumab (Amgen/Astellas)
Company: Amgen/Astellas
Pharmaceutical class/therapeutic area: LDL cholesterol reducer/anti-PCSK9 monoclonal antibody
Current regulatory status: Filed for approval
คาดการณ์ยอดขายในปี 2015 sales: $77 million
คาดการณ์ยอดขายในปี 2020 sales: $1.947 billion
4. Toujeo (Sanofi)
Company: Sanofi
Pharmaceutical class/therapeutic area: Diabetes (long-acting insulin)
Current regulatory status: Filed for approval
คาดการณ์ยอดขายในปี 2015 sales: $139 million
คาดการณ์ยอดขายในปี 2020 sales: $1.692 billion
What to watch: You can bet that Sanofi execs will be looking closely at how well Toujeo, the
company's successor to the flagship (but now fading) long-acting insulin Lantus, performs in the
market as the company struggles with a flagging diabetes franchise. What's really giving Sanofi
heartburn is the prospect of competition from Eli Lilly's Lantus biosimilar, which is being marketed
as Abasria in the EU. The goal? $1.7 billion in sales in 2020.
5. Mepolizumab (GlaxoSmithKline)
Company: GlaxoSmithKline
Pharmaceutical class/therapeutic area: Severe asthma/anti-IL-5 monoclonal antibody
Current regulatory status: Filed for approval
คาดการณ์ยอดขายในปี 2015 sales: $28 million
คาดการณ์ยอดขายในปี 2020 sales: $1.161 billion
6. Cosentyx (Novartis)
Company: Novartis
Pharmaceutical class/therapeutic area: Psoriasis/anti-IL-17A monoclonal antibody
Current regulatory status: Filed for approval
คาดการณ์ยอดขายในปี 2015 sales: $133 million
คาดการณ์ยอดขายในปี 2020 sales: $1.099 billion
7. VX-809 + Kalydeco/ivacaftor (Vertex Pharmaceuticals)
Company: Vertex Pharmaceuticals
Pharmaceutical class/therapeutic area: Cystic fibrosis/CFTR corrector
Current regulatory status: Filed for approval
คาดการณ์ยอดขายในปี 2015 sales: $575 million
คาดการณ์ยอดขายในปี 2020 sales: $4.744 billion
8. LCZ696 (Novartis)
Company: Novartis
Pharmaceutical class/therapeutic area: Heart failure/AT1 & ARNI
Current regulatory status: Phase III trials
คาดการณ์ยอดขายในปี 2015 sales: $251 million
คาดการณ์ยอดขายในปี 2020 sales: $3.875 billion
What to watch: This one will be huge. If approved (once Novartis moves ahead and files the drug),
LCZ696 will be the first new drug launch with a hospitalization/death prevention in heart failure
patients indication in years. It has been granted the EU's version of priority review status.
9. Palbociclib (Pfizer)
Company: Pfizer
Pharmaceutical class/therapeutic area: Breast cancer/CDK 4 & 6 inhibitor
Current regulatory status: Filed for approval
คาดการณ์ยอดขายในปี 2015 sales: $281 million
คาดการณ์ยอดขายในปี 2020 sales: $3.078 billion
10. Selexipag (Actelion)
Company: Actelion
Pharmaceutical class/therapeutic area: Pulmonary arterial hypertension (PAH)/prostacyclin agonist
Current regulatory status: Phase III trials
คาดการณ์ยอดขายในปี 2015 sales: $18 million
คาดการณ์ยอดขายในปี 2020 sales: $1.245 billion
What to watch: Selexipag has the advantage over Glaxo's mepolizumab in terms of respiratory
launches, according to the EvaluatePharma researchers. As the report authors note, payers will likely
be reticent to prescribe a lung biologic to a large host of patients.
11. Brexpiprazole (Otsuka Holdings)
Company: Otsuka Holdings
Pharmaceutical class/therapeutic area: Schizophrenia/5-HT1A & D2 & 5-HT2
Current regulatory status: Filed for approval
คาดการณ์ยอดขายในปี 2015 sales: $95 million
คาดการณ์ยอดขายในปี 2020 sales: $1.141 billion
What to watch: This could be a game-changer in a field that hasn't seen too many of them in recent
years. The FDA is currently reviewing an NDA for the drug as a first-line schizophrenia treatment
and a secondary therapy for major depression. It would also be a natural successor to Otsuka's
antipsychotic Abilify, whose sales slid to $1.03 million in Q1 2014.
อ้างอิงจากhttp://www.biopharmadive.com/news/the-11-biggest-drug-launches-to-watch-in-2015/344075/
แต่กว่าจะเข้าเมืองไทยคงสักระยะครับ
1. Opdivo/nivolumab (Bristol-Myers Squibb)
Company: Bristol-Myers Squibb
Pharmaceutical class/therapeutic area: Cancer/anti-PD-1 monoclonal antibody
Current regulatory status: Filed for approval in U.S., EU
คาดการณ์ยอดขายในปี 2015 sales: $658 million
คาดการณ์ยอดขายในปี2020 sales: $7.122 billion
What to watch: Opdivo is projected to be the biggest new drug launch in the U.S. and one of the
biggest launches worldwide this decade. It became the first approved anti-PD-1 medication when it
was cleared in Japan and has shown promise in treating Hodgkin's lymphoma on top of multiple
myeloma (and is being tested on many other cancers). But the really good news for BMS is that
Opdivo has produced a better response rate in trials than Merck's competing (and historic) PD-1
inhibitor Keytruda (pembrolizumab). If that trend continues, then BMS could rule this exciting new
therapeutic class. The FDA is expected to decide on Opdivo approval by March.
2. Alirocumab (Sanofi/Regeneron)
Company: Sanofi/Regeneron
Pharmaceutical class/therapeutic area: LDL cholesterol reducer/anti-PCSK9 monoclonal antibody
Current regulatory status: Phase III trials
คาดการณ์ยอดขายในปี 2015 sales: $44 million
คาดการณ์ยอดขายในปี 2020 sales: $2.179 billion
What to watch: PCSK9 inhibitors, besides anti-PD-1 drugs, are the most exciting new therapeutic
class to come out of the woodwork in recent times. What makes these LDL-lowering drugs
particularly exciting is the timing of their filings, with doctors' groups in the U.S. and EU having
recently endorsed controversial new guidelines that significantly expand the use of statins. If that
course of action proves too risky, and PCSK9 drugs like alirocumab aren't prohibitively pricey, these
could become the go-to option in an absolutely critical field.
3. Evolocumab (Amgen/Astellas)
Company: Amgen/Astellas
Pharmaceutical class/therapeutic area: LDL cholesterol reducer/anti-PCSK9 monoclonal antibody
Current regulatory status: Filed for approval
คาดการณ์ยอดขายในปี 2015 sales: $77 million
คาดการณ์ยอดขายในปี 2020 sales: $1.947 billion
4. Toujeo (Sanofi)
Company: Sanofi
Pharmaceutical class/therapeutic area: Diabetes (long-acting insulin)
Current regulatory status: Filed for approval
คาดการณ์ยอดขายในปี 2015 sales: $139 million
คาดการณ์ยอดขายในปี 2020 sales: $1.692 billion
What to watch: You can bet that Sanofi execs will be looking closely at how well Toujeo, the
company's successor to the flagship (but now fading) long-acting insulin Lantus, performs in the
market as the company struggles with a flagging diabetes franchise. What's really giving Sanofi
heartburn is the prospect of competition from Eli Lilly's Lantus biosimilar, which is being marketed
as Abasria in the EU. The goal? $1.7 billion in sales in 2020.
5. Mepolizumab (GlaxoSmithKline)
Company: GlaxoSmithKline
Pharmaceutical class/therapeutic area: Severe asthma/anti-IL-5 monoclonal antibody
Current regulatory status: Filed for approval
คาดการณ์ยอดขายในปี 2015 sales: $28 million
คาดการณ์ยอดขายในปี 2020 sales: $1.161 billion
6. Cosentyx (Novartis)
Company: Novartis
Pharmaceutical class/therapeutic area: Psoriasis/anti-IL-17A monoclonal antibody
Current regulatory status: Filed for approval
คาดการณ์ยอดขายในปี 2015 sales: $133 million
คาดการณ์ยอดขายในปี 2020 sales: $1.099 billion
7. VX-809 + Kalydeco/ivacaftor (Vertex Pharmaceuticals)
Company: Vertex Pharmaceuticals
Pharmaceutical class/therapeutic area: Cystic fibrosis/CFTR corrector
Current regulatory status: Filed for approval
คาดการณ์ยอดขายในปี 2015 sales: $575 million
คาดการณ์ยอดขายในปี 2020 sales: $4.744 billion
8. LCZ696 (Novartis)
Company: Novartis
Pharmaceutical class/therapeutic area: Heart failure/AT1 & ARNI
Current regulatory status: Phase III trials
คาดการณ์ยอดขายในปี 2015 sales: $251 million
คาดการณ์ยอดขายในปี 2020 sales: $3.875 billion
What to watch: This one will be huge. If approved (once Novartis moves ahead and files the drug),
LCZ696 will be the first new drug launch with a hospitalization/death prevention in heart failure
patients indication in years. It has been granted the EU's version of priority review status.
9. Palbociclib (Pfizer)
Company: Pfizer
Pharmaceutical class/therapeutic area: Breast cancer/CDK 4 & 6 inhibitor
Current regulatory status: Filed for approval
คาดการณ์ยอดขายในปี 2015 sales: $281 million
คาดการณ์ยอดขายในปี 2020 sales: $3.078 billion
10. Selexipag (Actelion)
Company: Actelion
Pharmaceutical class/therapeutic area: Pulmonary arterial hypertension (PAH)/prostacyclin agonist
Current regulatory status: Phase III trials
คาดการณ์ยอดขายในปี 2015 sales: $18 million
คาดการณ์ยอดขายในปี 2020 sales: $1.245 billion
What to watch: Selexipag has the advantage over Glaxo's mepolizumab in terms of respiratory
launches, according to the EvaluatePharma researchers. As the report authors note, payers will likely
be reticent to prescribe a lung biologic to a large host of patients.
11. Brexpiprazole (Otsuka Holdings)
Company: Otsuka Holdings
Pharmaceutical class/therapeutic area: Schizophrenia/5-HT1A & D2 & 5-HT2
Current regulatory status: Filed for approval
คาดการณ์ยอดขายในปี 2015 sales: $95 million
คาดการณ์ยอดขายในปี 2020 sales: $1.141 billion
What to watch: This could be a game-changer in a field that hasn't seen too many of them in recent
years. The FDA is currently reviewing an NDA for the drug as a first-line schizophrenia treatment
and a secondary therapy for major depression. It would also be a natural successor to Otsuka's
antipsychotic Abilify, whose sales slid to $1.03 million in Q1 2014.
อ้างอิงจากhttp://www.biopharmadive.com/news/the-11-biggest-drug-launches-to-watch-in-2015/344075/
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