{"id":87856,"date":"2022-09-19T07:35:39","date_gmt":"2022-09-19T05:35:39","guid":{"rendered":"https:\/\/www.formycon.com\/?page_id=87856"},"modified":"2025-03-19T19:01:10","modified_gmt":"2025-03-19T18:01:10","slug":"fyb206","status":"publish","type":"page","link":"https:\/\/www.formycon.com\/en\/biosimilars\/fyb206\/","title":{"rendered":"FYB206"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;0&#8243; bottom_padding=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243;][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;3&#8243; back_color=&#8221;color-xsdn&#8221; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;-3&#8243; shift_y_fixed=&#8221;yes&#8221; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243;][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; equal_height=&#8221;yes&#8221; gutter_size=&#8221;0&#8243; shift_y=&#8221;0&#8243;][vc_column_inner column_width_use_pixel=&#8221;yes&#8221; position_vertical=&#8221;middle&#8221; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;2&#8243; align_mobile=&#8221;align_center_mobile&#8221; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; column_width_pixel=&#8221;800&#8243;][vc_custom_heading text_color=&#8221;color-155072&#8243; heading_semantic=&#8221;h1&#8243; text_size=&#8221;h5&#8243; text_weight=&#8221;700&#8243; text_transform=&#8221;uppercase&#8221; text_space=&#8221;fontspace-210350&#8243; separator_color=&#8221;yes&#8221; separator=&#8221;yes&#8221;]FYB206[\/vc_custom_heading][vc_custom_heading text_color=&#8221;color-186842&#8243; heading_semantic=&#8221;p&#8221; text_weight=&#8221;700&#8243; uncode_shortcode_id=&#8221;441501&#8243; text_color_type=&#8221;uncode-palette&#8221;]Pembrolizumab biosimilar candidate[\/vc_custom_heading][vc_custom_heading heading_semantic=&#8221;p&#8221; text_size=&#8221;h3&#8243; text_weight=&#8221;300&#8243; text_height=&#8221;fontheight-357766&#8243; uncode_shortcode_id=&#8221;142465&#8243;]FYB206 is a biosimilar candidate for Keytruda<strong><sup>\u00ae<\/sup><\/strong> (pembrolizumab). 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override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;4&#8243; bottom_padding=&#8221;2&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243;][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243;][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;4&#8243; shift_y=&#8221;0&#8243;][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;3\/12&#8243;][vc_separator sep_color=&#8221;accent&#8221;][vc_empty_space empty_h=&#8221;1&#8243;][vc_column_text text_lead=&#8221;yes&#8221; uncode_shortcode_id=&#8221;550990&#8243;]<strong>Scope of therapeutic indication<\/strong>[\/vc_column_text][\/vc_column_inner][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;9\/12&#8243;][vc_separator sep_color=&#8221;color-100636&#8243;][vc_empty_space empty_h=&#8221;1&#8243;][vc_column_text text_lead=&#8221;yes&#8221; uncode_shortcode_id=&#8221;184392&#8243;]The active ingredient pembrolizumab is a<strong> humanized monoclonal antibody<\/strong> that belongs to the group of<strong> immune checkpoint inhibitors<\/strong> and is used to<strong> treat a variety of tumors<\/strong>. Pembrolizumab binds to the PD-1 receptor and specifically blocks the interaction between PD-1 and its ligand PD-L1. This <strong>helps the immune system to activate the body&#8217;s own cellular anti-tumor immune response<\/strong> and kill melanoma cells, for example.<\/p>\n<p>The specific mechanism of PD-1 blockade is not limited to one type of cancer, but is effective in numerous oncological indications. In addition to <strong>advanced melanoma<\/strong> (black skin cancer), pembrolizumab is indicated for <strong>non-small cell lung cancer<\/strong> and<strong> classical Hodgkin&#8217;s lymphoma<\/strong> (malignant disease of the lymphatic system). Non-small cell lung cancer is one of the most common cancer indications worldwide. In Germany alone, 50,000 people are diagnosed with the disease every year.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;4&#8243; bottom_padding=&#8221;5&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243;][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243;][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;4&#8243; shift_y=&#8221;0&#8243;][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/4&#8243;][vc_separator sep_color=&#8221;accent&#8221;][vc_empty_space empty_h=&#8221;1&#8243;][vc_column_text text_lead=&#8221;yes&#8221; uncode_shortcode_id=&#8221;191290&#8243;]<strong>Our development work<\/strong>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;3\/4&#8243;][vc_separator sep_color=&#8221;color-100636&#8243;][vc_empty_space empty_h=&#8221;1&#8243;][vc_column_text text_lead=&#8221;yes&#8221; uncode_shortcode_id=&#8221;117324&#8243;]After <strong>establishing the manufacturing process<\/strong> and <strong>aligning the study design<\/strong> with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), Formycon announced the <strong>start of the Phase I clinical trial with the &#8220;first patient in&#8221;<\/strong> on June 13, 2024. This makes Formycon <strong>one of the first three biosimilar developers<\/strong> to announce entry into the clinical development phase for the EU and US markets.<\/p>\n<p>The Phase I study compares the <strong>pharmacokinetics (PK), safety and tolerability<\/strong> of FYB206 with the reference drug Keytruda\u00ae in patients who have had surgery to remove malignant melanoma (black skin cancer). Recruitment for the parallel Phase III clinical trial is also expected to start very soon.<\/p>\n<p>Important <strong>IP<\/strong> has already been established and patented, including the <strong>development of alternative formulations<\/strong>.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;4&#8243; bottom_padding=&#8221;7&#8243; back_color=&#8221;color-144391&#8243; back_image=&#8221;80490&#8243; overlay_color=&#8221;color-144391&#8243; overlay_alpha=&#8221;75&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243;][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243;][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;4&#8243; shift_y=&#8221;0&#8243;][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; style=&#8221;dark&#8221; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/4&#8243;][vc_separator sep_color=&#8221;accent&#8221;][vc_empty_space empty_h=&#8221;1&#8243;][vc_column_text text_lead=&#8221;yes&#8221; uncode_shortcode_id=&#8221;131519&#8243;]<strong>The market<\/strong>[\/vc_column_text][\/vc_column_inner][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; style=&#8221;dark&#8221; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;3\/4&#8243;][vc_separator sep_color=&#8221;color-144391&#8243;][vc_empty_space empty_h=&#8221;1&#8243;][vc_column_text text_lead=&#8221;yes&#8221; uncode_shortcode_id=&#8221;102541&#8243;]<a href=\"#_edn2\" name=\"_ednref2\"><\/a>With its <strong>broad range of indications<\/strong> in oncology and <strong>sales of USD 25 billion in 2023<\/strong>[i], Keytruda<sup>\u00ae<\/sup>\u00a0is currently <strong>the world\u2019s best-selling drug<\/strong>. Due to the increasing number of cancers diagnoses around the world \u2013 the International Agency for Research on Cancer (IARC) predicts an increase of 77% by 2050[ii]\u00a0\u2013<strong> further growth in sales are forecasted<\/strong> <strong>for pembrolizumab<\/strong> over the coming years.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_empty_space empty_h=&#8221;2&#8243;][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;0&#8243; bottom_padding=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; shift_y_fixed=&#8221;yes&#8221; z_index=&#8221;0&#8243; shift_y_down=&#8221;0&#8243;][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;4&#8243; back_color=&#8221;color-155072&#8243; overlay_alpha=&#8221;25&#8243; shadow=&#8221;xl&#8221; shift_x=&#8221;0&#8243; shift_y=&#8221;-4&#8243; shift_y_fixed=&#8221;yes&#8221; shift_y_down=&#8221;0&#8243; z_index=&#8221;1&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; css_animation=&#8221;bottom-t-top&#8221; shadow_responsive=&#8221;yes&#8221; width=&#8221;1\/1&#8243; link_to=&#8221;|||&#8221;][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;4&#8243; shift_y=&#8221;0&#8243;][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;0&#8243; style=&#8221;dark&#8221; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243;][vc_separator sep_color=&#8221;color-xsdn&#8221; el_width=&#8221;25%&#8221;][vc_column_text text_lead=&#8221;yes&#8221; uncode_shortcode_id=&#8221;119087&#8243;]<strong>Next milestones<\/strong>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_empty_space empty_h=&#8221;1&#8243;][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;4&#8243; shift_y=&#8221;0&#8243;][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;4&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243;][vc_column_text text_lead=&#8221;yes&#8221; uncode_shortcode_id=&#8221;194177&#8243;]Following the <strong>start of the Phase I clinical trial<\/strong> mid June 2024, the start of the<strong> parallel Phase III clinical trial<\/strong> was announced on July 30, 2024.<\/p>\n<p>Based on intensive scientific dialogue with the U.S. Food and Drug Administration (FDA) regarding the clinical development programme, Formycon has concluded that the continuation of the Phase III clinical trial is no longer necessary for the development and approval of FYB206 in the U.S. The therapeutic comparability of FYB206 with the reference drug Keytruda<sup>\u00ae<\/sup>\u00a0can be sufficiently demonstrated based on the comprehensive analytical data and the data from the parallel phase I trial (\u201cDahlia\u201d) in patients with malignant melanoma (black skin cancer). Formycon therefore announced in February 2025 that it would be discontinuing the Phase III clinical trial.<\/p>\n<p>Our goal is the <strong>product launch in the US and the EU<\/strong> when patent protection for the reference product expires.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;7&#8243; bottom_padding=&#8221;5&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243;][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243;][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;4&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243;][vc_column_inner width=&#8221;1\/4&#8243;][vc_separator sep_color=&#8221;color-674378&#8243; icon_position=&#8221;left&#8221; el_height=&#8221;2px&#8221;][\/vc_column_inner][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;3\/4&#8243;][\/vc_column_inner][\/vc_row_inner][vc_column_text uncode_shortcode_id=&#8221;212251&#8243;]* Keytruda<em>\u00ae<\/em> is a registered trademark of Merck Sharp &amp; Dohme LLC, a subsidiary of Merck &amp; Co, Inc, Rahway, NJ\/USA.<\/p>\n<p>&nbsp;<\/p>\n<hr \/>\n<p>&nbsp;<\/p>\n<p>[i] Merck Announces Fourth-Quarter and Full-Year 2023 Financial Results \u2013 <a href=\"https:\/\/www.merck.com\/news\/merck-announces-fourth-quarter-and-full-year-2023-financial-results\/\">https:\/\/www.merck.com\/news\/merck-announces-fourth-quarter-and-full-year-2023-financial-results\/<\/a><\/p>\n<p>[ii] World Health Organization (WHO): Global cancer burden growing, amidst mounting need for services &#8211; 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