By the time 2020 ends in a couple of short weeks, the US Food and Drug Administration (FDA) will have made decisions on the fate of at least two proposed biosimilars. In addition, a few manufacturers have announced plans to complete the 351(k) application process by the end of the year. Based on our current database of publicly announced biosimilar approvals and applications, the turn of 2020, here are some of the latest updates.
On November 22, Tanvex BioPharma resubmitted to the FDA its biosimilar application for TX-01, referencing Neupogen®. As reported earlier, Tanvex had received a complete response letter in September 2019, which did not require additional clinical data. Tanvex hopes to hear a decision on the resubmitted application by May 2021. The company also announced its intention to submit its bevacizumab biosimilar application (TX-05) to the FDA in mid-2021.
Bio-Thera Solutions of Gangzhou, China, announced in late November that it had submitted a marketing authorization application to the European Medicines Agency for its bevacizumab biosimilar BAT-1706. In its press release, Bio-Thera reiterated its intention to file a 351(k) application with the US Food and Drug Administration before the end of 2020.
Coherus Biosciences has had reiterated its intention to file for FDA approval of CHS-1420, its adalimumab biosimilar, before the end of 2020. Therefore, we expect to see an update on this shortly. On another Coherus note, the FDA had requested more data in Bioeq and Formycon AG’s original application for FYB201 (a ranibizumab biosimilar). This request was related to a change in equipment used in manufacturing. As a result, the application was withdrawn, and Coherus, in its latest earnings report, indicated that it intended to resubmit the 351(k) application in 2021.
The FDA had given Amgen a December 19th decision date for its biosimilar version of rituximab (ABP 798). Hopefully, we will be reporting on this in the next few days. An approval would provide Amgen and its partner Allergan the third rituximab biosimilar on the market. Samsung Bioepis is also awaiting word on SB8, its biosimilar version of bevacizumab, which it filed in November 2019. An approval would also give Samsung the third biosimilar in the Avastin® market.