Mylan N.V. and partner Fujifilm Kyowa Kirin Biologics Co., Ltd. announced that the FDA has approved a biosimilar of blockbuster drug, Humira (adalimumab-fkjp), under the brand name Hulio.
The biosimilar has been approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis (4 years and older), psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis, in both prefilled syringe and auto-injector presentations.
Given the wide market potential of Hulio, the approval will strengthen Mylan’s biosimilars portfolio, which already comprises biosimilars to Neulasta and Herceptin. Humira recorded sales of approximately $14.9 billion in the United States for the 12 months ending December 2019.
Per a patent license agreement with AbbVie (ABBV - Free Report) , Mylan will be able to launch Hulio in the United States in July 2023.
However, Hulio carries a Boxed Warning for an increased risk of serious infections leading to hospitalization or death, such as tuberculosis (TB), bacterial sepsis, invasive fungal infections and infections due to opportunistic pathogens.
We note that Mylan and Fujifilm Kyowa Kirin Biologics entered into a partnership in 2018 for the commercialization of Hulio in Europe. Mylan has commercialized the product in several countries across the region. The partnership was expanded in 2019.
Earlier, Mylan and partner Lupin obtained European Commission’s (EC) approval for Nepexto, a biosimilar to Enbrel, for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis and pediatric plaque psoriasis.
These new approvals have boosted the company’s performance, given the downturn in the generic business.
Mylan and partner Biocon Ltd. recently obtained FDA approval for the New Drug Application (NDA) for diabetes treatment, Semglee (insulin glargine injection), in vial and pre-filled pen presentations. It has been approved for controlling high blood sugar in adults with type 2 diabetes, and adult and pediatric patients with type 1 diabetes. Per the companies, Semglee has an identical amino acid sequence to Sanofi's (SNY - Free Report) Lantus and is approved for the same indications.
The company recently won regulatory approval for remdesivir lyophilized powder for injection (100 mg/vial) in India for restricted emergency use in COVID-19 patients.
Mylan’s stock has lost 21.3% in the year so far compared with the industry’s decline of 7.3%.
Meanwhile, the company’s decision to merge with Upjohn, Pfizer's (PFE - Free Report) off-patent branded and generic established medicines business, is also encouraging. In November 2019, the companies announced the name of the new entity to be Viatris. The merger will be completed in the second half of 2020.
However, the impact of the coronavirus outbreak is most likely to negatively impact the second-quarter results.
Mylan currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Mylan N.V. and partner Fujifilm Kyowa Kirin Biologics Co., Ltd. announced that the FDA has approved a biosimilar of blockbuster drug, Humira (adalimumab-fkjp), under the brand name Hulio.
The biosimilar has been approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis (4 years and older), psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis, in both prefilled syringe and auto-injector presentations.
Given the wide market potential of Hulio, the approval will strengthen Mylan’s biosimilars portfolio, which already comprises biosimilars to Neulasta and Herceptin. Humira recorded sales of approximately $14.9 billion in the United States for the 12 months ending December 2019.
Per a patent license agreement with AbbVie (ABBV - Free Report) , Mylan will be able to launch Hulio in the United States in July 2023.
However, Hulio carries a Boxed Warning for an increased risk of serious infections leading to hospitalization or death, such as tuberculosis (TB), bacterial sepsis, invasive fungal infections and infections due to opportunistic pathogens.
We note that Mylan and Fujifilm Kyowa Kirin Biologics entered into a partnership in 2018 for the commercialization of Hulio in Europe. Mylan has commercialized the product in several countries across the region. The partnership was expanded in 2019.
Earlier, Mylan and partner Lupin obtained European Commission’s (EC) approval for Nepexto, a biosimilar to Enbrel, for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis and pediatric plaque psoriasis.
These new approvals have boosted the company’s performance, given the downturn in the generic business.
Mylan and partner Biocon Ltd. recently obtained FDA approval for the New Drug Application (NDA) for diabetes treatment, Semglee (insulin glargine injection), in vial and pre-filled pen presentations. It has been approved for controlling high blood sugar in adults with type 2 diabetes, and adult and pediatric patients with type 1 diabetes. Per the companies, Semglee has an identical amino acid sequence to Sanofi's (SNY - Free Report) Lantus and is approved for the same indications.
The company recently won regulatory approval for remdesivir lyophilized powder for injection (100 mg/vial) in India for restricted emergency use in COVID-19 patients.
Mylan’s stock has lost 21.3% in the year so far compared with the industry’s decline of 7.3%.
Meanwhile, the company’s decision to merge with Upjohn, Pfizer's (PFE - Free Report) off-patent branded and generic established medicines business, is also encouraging. In November 2019, the companies announced the name of the new entity to be Viatris. The merger will be completed in the second half of 2020.
However, the impact of the coronavirus outbreak is most likely to negatively impact the second-quarter results.
Mylan currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
These Stocks Are Poised to Soar Past the Pandemic
The COVID-19 outbreak has shifted consumer behavior dramatically, and a handful of high-tech companies have stepped up to keep America running. Right now, investors in these companies have a shot at serious profits. For example, Zoom jumped 108.5% in less than 4 months while most other stocks were sinking.
Our research shows that 5 cutting-edge stocks could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of this decade, especially for those who get in early.
See the 5 high-tech stocks now>>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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