Mylan N.V. MYL and partner Biocon Ltd. 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.
It was approved as a drug product under the 505(b)(2) NDA pathway and is now deemed a biologic under section 351(a), in accordance with the Biologics Price Competition and Innovation Act in line with other insulin products.
Per the companies, Semglee has an identical amino acid sequence to Sanofi's SNY Lantus and is approved for the same indications.
The approval of Semglee was based on an analytical, preclinical and clinical program (including the INSTRIDE studies), which confirmed the PK/PD, efficacy, safety and immunogenicity of the drug in comparison to Lantus in patients with type 1 and type 2 diabetes.
Sanofi's total IQVIA sales for the 12 months ending Apr 30, 2020, were approximately $1.68 billion for Lantus 100 Units/mL Vial and approximately $4.33 billion for Lantus SoloSTAR Pen.
The approval brings an affordable treatment option for diabetes patients. It also broadens Mylan’s portfolio, which comprises Glatiramer Acetate, Yupelri, biosimilars to Neulasta and Herceptin, as well as a drug-device combination product, Wixela Inhub, which is the generic of GlaxoSmithKline’s GSK Advair Diskus,
These new approvals have boosted the company’s performance, given the downturn in the generic business.
Mylan’s stock has lost 19.9% in the year so far compared with the industry’s decline of 10%.
Last week, 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.
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, Mylan and Pfizer 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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