Below are regulatory and development updates regarding a number of biosimilar candidates.
- Today, Amgen and Allergen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorization of ABP 215, their proposed biosimilar of Avastin® (bevacizumab). According to the press release, “The positive CHMP opinion for ABP 215 marks the first time a bevacizumab biosimilar has been recommended for approval in the European Union, which is an exciting milestone for Amgen.” Amgen’s U.S. application for this biosimilar was approved by FDA two months ago under the brand Mvasi™ (bevacizumab-awwb), which is the subject of recent patent litigation.
- Yesterday, Pfenex reported on its Q3 2017 earnings call that it has decided to halt development of PF582 and PF529, biosimilar candidates to Lucentis® (ranibizumab) and Neulasta® (pegfilgrastim), respectively. Pfenex CEO Eef Schimmelpennink explained on the call that while “[b]oth programs have clearly laid out development pathway and with the right resources we believe both PF582 and PF529 could be significant opportunities, … given the resources needed for further development of these two by similar candidates, we have decided to close our development activities and focus our efforts and resources elsewhere in our product portfolio.” The decision was reportedly based on “a full strategic review of both 582, 529,” including of the “timeline for development and cost and how we maximize shareholder value.” Mr. Schimmelpennink added that “we have decided that we would pause the activities for those two programs and focus on our development efforts elsewhere within the portfolio until strategic partnerships for these candidates are forged, so we continue to engage with potential strategic partners. But, until that time, we are focusing our efforts elsewhere.”
- Last week, Cinfa Biotech announced that it plans to present data from its clinical development program for its lead development candidate B12019, a biosimilar version of Neulasta® (pegfilgrastim), at the Annual Meeting of the American Society of Hematology next month. The data will concern the immunogenicity and pharmacodynamic comparability of B12019 and Neulasta®. This announcement follows the EMA’s acceptance last month of Cinfa’s application for approval of this proposed biosimilar.
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