Year in Review: Top Deals in 2022

According to PwC, “2022 has been a challenging year for M&A in the pharmaceutical and life sciences sector, with both deal value and volume at multiyear lows thanks to overall macro headwinds coupled with broad-based market dislocation.”  PwC expects “M&A to more closely resemble prior years with a total deal value in the $225 billion to $275 billion range across all subsectors.”  Below is a recap of the top M&A deals in 2022 that focus on biologics and biosimilars.

1. Biocon Biologics Spent $3B to Acquire Viatris’ Biosimilars Business

In December, Biocon completed its deal to acquire the global biosimilars business of Viatris for $2 billion upfront and another $1 billion in compulsorily convertible preference shares.  According to Biocon, the acquisition included trastuzumab, pegfilgrastim, bevacizumab, insulin glargine, insulin aspart, and pertuzumab assets. In addition, with the acquisition Biocon now owns rights to a biosimilar aflibercept, as well as rights to Viatris’s in-licensed adalimumab and etanercept biosimilars.  According to Biocon’s press release, the Viatris and Biocon teams will continue to work together over a two-year transition period.

2. Samsung Biologics Completes Full Acquisition of Samsung Bioepis

In January, Biogen reached an agreement to sell its equity stake in the Samsung Bioepis joint venture to partner Samsung Biologics for an aggregate consideration of up to $2.3 billion. In April, Samsung Biologics and Biogen announced that Samsung Biologics fully completed its acquisition of Samsung Bioepis. The acquisition marked a significant milestone for Samsung Biologics in its continued venture into the biosimilar business. According to Biogen, it will continue to work with Samsung Bioepis with their exclusive agreements, including the commercialization of their current biosimilars portfolio, including BENEPALI (etanercept), FLIXABI (infliximab), IMRALDI (adalimumab) in Europe, and the potential upcoming launches of BYOOVIZ and the potential filings for SB15 worldwide.  BYOOVIZ (ranibizumab-nuna) is a biosimilar to LUCENTIS (ranibizumab), approved by FDA in September 2021. SB15 is Biogen’s biosimilar candidate referencing EYLEA (aflibercept).

3. International Deals: Formycon/ATHOS, Fresenius/mAbxience/Ivenix, and Intas/Axantia

In March, Formycon and ATHOS agreed to merge their development activities in the area of biosimilars through a long-term strategic partnership.  Formycon will acquire 100% of the rights in FYB202, a biosimilar candidate for Stelara, a 50% stake of ATHOS in FYB201, a biosimilar candidate for Lucentis, and the operational development unit Bioeq GmbH.

Also in March, Fresenius Kabi announced that it has agreed to acquire a 55% stake of mAbxience.  The purchase price will be a combination of €495 million upfront payment and milestone payments, tied to the achievement of commercial and development targets.  mAbxience has two commercialized biosimilar products (rituximab and bevacuzumab). According to Fresenius, through its in-house biosimilars programs and through its investment in mAbxience, Fresensius expects to “capture an overproportionate share of the underlying rapid growth in the biopharmaceutical market.”

In April, Intas signed an exclusive license and supply agreement with Axantia for ranibizumab, a biosimilar version of Lucentis.  Under the terms of this agreement, Axantia will register, hold the marketing authorization, and commercialize ranibizumab in certain territories including Saudi Arabia, Jordan, Iraq, Lebanon, and GCC countries.