Biocon Biologics Completes $3 Billion Acquisition of Viatris’ Biosimilars

Biocon Biologics has acquired Viatris’ biosimilars business for $2 billion in cash. In addition, Viatris will have $1 billion of convertible preferred equity stake, about 12.9%, in Biocon Biologics. The acquisition provides Biocon Biologics with eight commercial biosimilars, and is part of Viatris’ efforts to reposition the company and pay down debt related to phase 1 research the company’s acquisition of two ophthalmology business: Oyster Point Pharma and Famy Life Sciences, which are expected to close in the first quarter of 2023.

Biocon Biologics now has full ownership of several biosimilars, including: trastuzumab, pegfilgrastim, bevacizumab, glargine, aspart, pertuzumab and glargine 300U, as well as Viatris’ rights for the in-licensed immunology products of adalimumab and atanercept. Biocon Biologics has also acquired Viatris’ rights for the biosimilar of Eylea (aflibercept), which is used to treat several ophthalmology conditions. Viatris has been the first to file aflibercept in the United States.

Viatris will provide commercialization and other services for a two-year transition period and then Biocon Biologics will assume responsibility of commercial, regulatory and other related services.

In generic and biosimilar news news:

• Amneal has launched Releuko (filgrastim-ayow), a biosimilar referencing Amgen’s Neupogen. The therapy is used to treat neutropenia, which can lead to infection. It is commonly experienced by patients undergoing chemotherapy. This product was developed in collaboration with Kashiv Biosciences. Releuko was approved in March 2022 for intravenous and subcutaneous use.

• The FDA has approved Ani Pharmaceuticals’ abbreviated new drug application (ANDA) for Fluoxetine Oral Solution, a generic version of Eli Lilly’s Prozac.

• Aucta Pharmaceuticals has begun shipping vigabatrin for oral solution 500 mg, following FDA approval of its abbreviated new drug application. Aucta’s commercial partner Upsher-Smith Laboratories will launch vigabatrin under the brand name Vigadrone, which offers patients and physicians a fully substitutable generic alternative to Lundbeck’s Sabril (vigabatrin) powder for oral solution. It is used to treat infantile spasms and refractory complex partial seizures.

• Cipla has launched Leuprolide Acetate Injection Depot 22.5mg, a generic version of AbbVie’s Lupron Depot. Lupron is approved for several indications, including endometriosis, uterine fibroids, advanced prostate cancer, and central precocious puberty.