This week Formycon AG ("Formycon") announced details of its previously undisclosed pipeline project for FYB206, Formycon's biosimilar of KEYTRUDA (pembrolizumab). KEYTRUDA is approved for the treatment of advanced melanoma, lung and other types of carcinoma. According to the press release, Formycon fully owns the development and commercialization rights for FYB206, and "[i]mportant IP has already been created and patent applications have been filed, with data from the development of alternative formulations." Forymcon states that, "[f]ollowing convincing results from the extensive analytical protein characterization as well as significant progress in the development of the manufacturing process, a comprehensive data package is currently being compiled in order to closely align further program steps in Scientific Advice Meetings with the EMA and FDA in the second half of the year." Formcyon is also planning adjustments to the manufacturing process for commercial scale, and has a secured GMP manufacturing capacity at a contract manufacturer. According to the press release, Formycon has six biosimilars in development.
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