Biosimilar Pipeline Update

Below are some recent announcements from Momenta Pharmaceuticals, Fresenius Kabi, JHL Biotech, and Innovent Biologics regarding their biosimilar pipelines.

On October 1, 2018, Momenta Pharmaceuticals announced that it completed a strategic review of its pipeline with the goal of reducing costs of biosimilar development and focusing its resources on its pipeline of novel drug candidates for immune-mediated diseases.  According to the announcement, Momenta plans to identify a commercialization partner for the further development of M923, its proposed biosimilar to Humira® (adalimumab). Momenta reported earlier this year that it was prepared to file an aBLA for M923 with the FDA, but was holding off on filing pending the results of its strategic review.  Momenta also indicated that it plans to continue its collaboration with Mylan on the development of M710, its proposed biosimilar to Eylea® (aflibercept), but has initiated discussions with Mylan to exit its participation in the development of its other five biosimilar programs including M834, a proposed biosimilar to Orencia®. As we have previously reported, Momenta is appealing a PTAB decision upholding the patentability of BMS’s U.S. Patent No. 8,476,239, which relates to BMS’s Orencia® (abatacept) product. Following the press release, Momenta informed the Court of the announcement. In response, BMS filed a letter with the Court citing Momenta’s press release as confirmation of “Momenta’s lack of Article III standing.”

On October 9, 2018, Fresenius Kabi announced the results of two clinical studies of MSB11455, its biosimilar candidate of Neulasta® (pegfilgrastim).  The press release indicates that the first study, designed to study the pharmacokinetic and pharmacodynamic bioequivalence, met all primary endpoints including Cmax, area under the curve (AUC), and absolute neutrophil count (ANC). The second study, designed to compare the immunogenicity of MSB11455 and Neulasta®, met its primary endpoints showing positive anti-drug antibodies status and no neutralizing antibodies between both groups.

Two more announcements were released today, first, JHL Biotech announced that China’s National Medical Products Administration (NMPA, formerly known as the CFDA) has approved JHL’s Phase I and Phase III Clinical Trial Application for a proposed bevacizumab biosimilar, JHL1149, to treat several forms of cancer, including advanced non-squamous non-small-cell lung cancer (NSCLC), metastatic colorectal cancer, metastatic kidney cancer, advanced cervical cancer and recurrent ovarian cancer. Accoding to the announcement, JHL’s China NMPA Phase III trial approval together with the UK MHRA trial approval mark the start of JHL’s global Phase III clinical trial program.

Second, Innovent Biologics, Inc. announced today that its IND application for a combination therapy of IBI308 (Sintilimab, an anti-PD-1 monoclonal antibody) and IBI305 (a proposed biosimilar to the recombinant humanized anti-VEGF monoclonal antibody bevacizumab), has been approved by China’s NMPA for clinical development.  According to the press release, Innovent will initiate clinical trials on this combination to assess its safety and efficacy in patients with Non-Small Cell Lung Cancer (NSCLC) and hepatocellular carcinoma (HCC).

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