Tony Hagen is senior managing editor for The Center for Biosimilars®.
Biocon and Viatris edge closer to EU marketing authorization for a bevacizumab biosimilar, among other biosimilar business developments.
Samsung Bioepis Begins Ustekinumab Trial
Samsung Bioepis has begun a phase 1 clinical trial for its proposed ustekinumab biosimilar (SB17), referencing Stelara. Ustekinumab is for the treatment of plaque psoriasis and psoriatic arthritis. The company said the trial is a randomized, double-blind, 3-arm, single-dose study comparing pharmacokinetics, safety, tolerability, and immunogenicity of SB17 and the originator drug in healthy men.
Investigators will enroll 201 volunteers 18 to 55 years of age and randomize them 1:1:1 to a 45 mg dose of SB17, EU-sourced Stelara, or US-sourced Stelara. Primary end points are drug exposure following administration and peak drug concentration, and secondary end points are adverse events and development of antidrug antibodies to ustekinumab.
Samsung Bioepis has 3 biosimilar candidates in phase 3 development: eculizumab (SB12, immunosuppression), aflibercept (SB15, ophthalmology), and denosumab (SB16, osteoporosis).
CHMP Recommends Abevmy
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for marketing authorization of a bevacizumab biosimilar candidate developed by Biocon Biologics and Viatris (formerly Mylan/Upjohn). A final decision on the drug approval application is anticipated from the European Commission in May 2021. The bevacizumab biosimilar candidate would be marketed under the brand name Abevmy in injectable doses of 100 mg and 400 mg. The product, for the treatment of cancer, references Avastin (Roche), and works by inhibiting the development of blood vessels that enable the tumor growth.
“CHMP’s decision to recommend approval of our biosimilar bevacizumab brings us a step closer to enable affordable access to this biologic therapy for cancer patients in the European Union along with our partner Viatris,” Kiran Mazumdar-Shaw, executive chair of Biocon Biologics, said in a statement.
Final authorization would enable Biocon and Viatris to market the biosimilar in 27 EU member countries and in the European Economic Area, which includes Norway, Iceland, and Liechtenstein. The United Kingdom is independently regulating drugs and approvals following Brexit; however, it has a “reliance procedure” under which EU-approved drugs can be marketed in the United Kingdom shortly after they receive a CHMP nod.
Cipla Expands Alvotech Partnership
Cipla, a Mumbai, India-based company, said it has agreed to manage the marketing and distribution of 4 Alvotech biosimilars in Australia and New Zealand. Alvotech is an Icelandic company with numerous biosimilars in development and a strategy to market them globally via multiple business partners once regulatory approvals are granted.
Cipla said a subsidiary, Cipla Gulf, would directly manage the sales and distribution under this agreement. The biosimilar candidates are aflibercept (ophthalmology), ustekinumab, denosumab (osteoporosis), and golimumab (rheumatoid arthritis), referencing Eylea, Stelara, Prolia/Xgeva, and Simponi, respectively.
Cipla Gulf was already under contract (2019) to market an Alvotech adalimumab biosimilar (AVT02) in emerging markets. AVT02 references the rheumatology and gastrointestinal treatment adalimumab (Humira).