“Biosimilars is one of the hottest topics in the bioprocess industry today and is too large a sector to be ignored,” Carsten Brockmeyer, CEO of Formycon told delegates this week at the Bioprocess International European Summit in Vienna, Austria.
His company is developing a range of biosimilars, but unlike the vast majority of the estimated 250 and growing developers of such products, Formycon is concentrating on "third wave" products.
First wave biosimilars are those copies of biological products already off patent, and are generally cytokines, growth factors and hormones such as filgrastim and epoetin alfa – copies of Amgen’s Neupogen and Epogen, respectively. Second wave biosimilars are generally monoclonal antibodies which come off patent before 2020, Pfizer/Celltrion’s recently US approved infliximab being an example.
Third wave biosimilars, according to Brockmeyer, are those biological products coming off patent after 2020 and generally more complex mAbs or antibody fragments. Formycon has three such products in its pipeline: versions of Genentech’s Lucentis (ranibizumab), Regeneron’s Eylea (aflibercept), and a third undisclosed molecule.
But to join the handful of developers delving into this distant market opportunity, Brockmeyer said “a full understanding of the mode-of-action for the biosimilar targets will be critical in picking the right cell lines and reverse engineer the upstream and downstream processes.”
Lucentis uses E. Coli as its host cell line, while Eylea uses Chinese Hamster Ovary (CHO) cells. Other examples of such products include Biogen’s Tysabri (natalizumab) and Janssen’s Stelera (ustekinumab), which use the mouse myeloma-derived NS0 and SP2/0 host cell lines, respectively.
Understanding the mode-of-action for these cell lines is essential for criticality assessment, he added, which would help fulfil the regulatory demands for evaluating quality attributes and equivalence through the US FDA’s three-tier assessment approach, which he said is yet to be fully understood by industry.