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Mylan (MYL) Obtains FDA Approval for Biosimilar of Humira

Zacks Equity Research
·3-min read

Mylan N.V. MYL 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, 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 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 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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