Biosimilar Pipeline Developments: Rituximab, Adalimumab, Eculizumab, Infliximab, Pegfilgrastim

Below are some recent updates regarding biosimilar pipelines from around the globe.

On November 2, 2018, Sandoz announced that it has decided “not [to] pursue its submission for biosimilar rituximab in the US at this time … follow[ing] a request by the US Food and Drug Administration (FDA) for additional information to complement the submission.”  According to the press release, Sandoz is “disappointed to have to make this decision and stand[s] behind the safety, efficacy and quality of [its] medicine, which met the stringent criteria for approval in the European Union, Switzerland, Japan, New Zealand and Australia.”  For the past eleven months, Sandoz has been engaged in patent litigation under the BPCIA regarding its U.S. regulatory application for its rituximab biosimilar.  To date, there have been no developments reflecting Sandoz’s new strategy in the BPCIA litigation.

On October 30, 2018, Amgen reported on its Q3 2018 earnings call that it is in the process of “preparing [its] US and EU regulatory submissions for ABP 710, our biosimilar Remicade [(infliximab)], which [it] expect[s] to occur by the first quarter of next year.”  Amgen also stated that it “achieved global alignment on the study design for ABP 959, [its] biosimilar Soliris [(eculizumab)], and [is] now in start-up of the Phase 3 pivotal study.”

Samsung Bioepis is also clinically developing an eculizumab biosimilar, under the name SB12.  According to, this month Samsung Bioepis is commencing a phase 1 study of SB12 “to evaluate PK, safety, tolerability, immunogenicity, and PD profiles of SB12, EU sourced Soliris, and US sourced Soliris in healthy subjects.”

On October 24, 2018, Finland-based Orion Corporation announced that it has signed a collaboration agreement with Amgen for the commercial marketing and sales of Amgen’s adalimumab biosimilar, Amgevita®, in Finland.  According to the press release, this will be Finland’s first adalimumab biosimilar, and the third biosimilar that Orion has commercialized in the country.

On October 20, 2018, Mundipharma, a global network of independent associated companies, announced that it has acquired biosimilar development company Cinfa Biotech and thereby “gain[ed] immediate access to [Cinfa’s] Pelmeg® (B12019), a biosimilar to Neulasta® (pegfilgrastim), which received CHMP recommendation for approval on 20th September 2018.”  Mundipharma’s press release states that “[b]y acquiring Cinfa Biotech we have now taken the first step in our plans to, not only expand our biosimilars footprint, but to develop future biosimilars which will continue to afford healthcare systems further savings and, in some cases, wider access for patients.”