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COLUMBUS-AMD study investigates the comparability of FYB201, an investigational biosimilar ranibizumab, and Lucentis®* in patients with neovascular age-related macular degeneration (nAMD)
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Study involves 650 participants in around 80 clinical centers worldwide
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Partners Formycon and bioeq significantly advance in the development of FYB201
MUNICH, Germany I February 23, 2016 I Formycon AG, Munich, and bioeq GmbH, Holzkirchen, today announced that they have enrolled the first patient in their clinical Phase III study involving FYB201, Formycon’s biosimilar version of Lucentis®. The objective of the study is to demonstrate the comparability of FYB201 and Lucentis® in terms of safety, effectiveness, and immunogenicity in patients with neovascular age-related macular degeneration (nAMD). This condition, known as wet AMD, is one of the primary causes of loss of vision in people over the age of 60 in developed countries. It is estimated that as many as 7.5 million people worldwide suffer from wet AMD. Germany alone has around 450,000 patients with the condition.
Lucentis® is a leading drug for the treatment of neovascular age-related macular degeneration. It inhibits the vascular endothelial growth factor (VEGF) responsible for the excessive formation of blood vessels in the retina, which leads to a progressive loss of vision. The total market volume for intraocular anti-VEGF treatments in 2015 was around US$ 7.5 billion, and is growing rapidly.
Dr. Björn Capsius, Director Clinical Development at Formycon, said: “We are delighted that, after intensive preparations, our study has now started to enroll its first patient. It is a major step forward in the development of our biosimilar and we will gain important data supporting the regulatory approval in the EU and US.”
Dr. Joachim Kiefer, Head of Clinical Development at bioeq, added: “The active ingredient ranibizumab is an effective and proven therapy for the treatment of age-related macular degeneration. By developing a high-quality and cost-effective biosimilar, we want to give as many patients as possible the opportunity to access this treatment option. This not only helps improve patient care, but also helps to reduce healthcare costs.”
At the end of 2013, Formycon licensed FYB201 exclusively to Santo Holding GmbH, Holzkirchen. bioeq GmbH, a subsidiary of Santo Holding GmbH, is the sponsor of the Phase III study and is also responsible for the global marketing and licensing of FYB201.
* Lucentis is a registered trademark of Genentech Inc.
About Formycon:
Formycon is a leading independ ent pure play developer of biosimilars and has become a recognized innovator in this field. The company has extensive experience in the development of complex biological molecules. Formycon’s specialist expertise allows the company to develop high-quality biosimilars that meet the strict regulatory requirements of highly regulated markets such as Europe and the United States. Formycon currently has three biosimilars under development, with further product candidates already identified. Two biosimilar candidates have been licensed out to Santo Holding GmbH.
About bioeq:
bioeq GmbH was established in March 2014 and is funded by the Strüngmann Group (Santo Holding) and by Polpharma, a leading Polish pharmaceutical company. bioeq is active in the development of biosimilars in compliance with standards required for approval and distribution in the EU, US and other highly regulated markets.
Starting from early stage development projects licensed from internationally renowned partners or cell lines stemming from affiliated companies, bioeq conducts development programs up to clinical development and registration. bioeq’s pipeline comprises several of the so-called “third wave” biosimilars, for which patent protection is due to expire within the next decade.
bioeq’s management team combines expert scientists and senior management with a skill set spanning from early stage development through to commercialization of complex molecules and biosimilars.
About biosimilars:
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis and multiple sclerosis. In the coming years, many of these biotech drugs will lose their patent protection – and by 2020, medications with revenues of more than USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. While the global market for biosimilars is currently some USD 2.5 billion, industry experts expect this figure to grow tenfold by the year 2020. In contrast to traditional generic drugs, the development and production of biosimilars is highly complex and requires specialized expertise.
SOURCE: Formycon
Post Views: 375
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COLUMBUS-AMD study investigates the comparability of FYB201, an investigational biosimilar ranibizumab, and Lucentis®* in patients with neovascular age-related macular degeneration (nAMD)
-
Study involves 650 participants in around 80 clinical centers worldwide
-
Partners Formycon and bioeq significantly advance in the development of FYB201
MUNICH, Germany I February 23, 2016 I Formycon AG, Munich, and bioeq GmbH, Holzkirchen, today announced that they have enrolled the first patient in their clinical Phase III study involving FYB201, Formycon’s biosimilar version of Lucentis®. The objective of the study is to demonstrate the comparability of FYB201 and Lucentis® in terms of safety, effectiveness, and immunogenicity in patients with neovascular age-related macular degeneration (nAMD). This condition, known as wet AMD, is one of the primary causes of loss of vision in people over the age of 60 in developed countries. It is estimated that as many as 7.5 million people worldwide suffer from wet AMD. Germany alone has around 450,000 patients with the condition.
Lucentis® is a leading drug for the treatment of neovascular age-related macular degeneration. It inhibits the vascular endothelial growth factor (VEGF) responsible for the excessive formation of blood vessels in the retina, which leads to a progressive loss of vision. The total market volume for intraocular anti-VEGF treatments in 2015 was around US$ 7.5 billion, and is growing rapidly.
Dr. Björn Capsius, Director Clinical Development at Formycon, said: “We are delighted that, after intensive preparations, our study has now started to enroll its first patient. It is a major step forward in the development of our biosimilar and we will gain important data supporting the regulatory approval in the EU and US.”
Dr. Joachim Kiefer, Head of Clinical Development at bioeq, added: “The active ingredient ranibizumab is an effective and proven therapy for the treatment of age-related macular degeneration. By developing a high-quality and cost-effective biosimilar, we want to give as many patients as possible the opportunity to access this treatment option. This not only helps improve patient care, but also helps to reduce healthcare costs.”
At the end of 2013, Formycon licensed FYB201 exclusively to Santo Holding GmbH, Holzkirchen. bioeq GmbH, a subsidiary of Santo Holding GmbH, is the sponsor of the Phase III study and is also responsible for the global marketing and licensing of FYB201.
* Lucentis is a registered trademark of Genentech Inc.
About Formycon:
Formycon is a leading independ ent pure play developer of biosimilars and has become a recognized innovator in this field. The company has extensive experience in the development of complex biological molecules. Formycon’s specialist expertise allows the company to develop high-quality biosimilars that meet the strict regulatory requirements of highly regulated markets such as Europe and the United States. Formycon currently has three biosimilars under development, with further product candidates already identified. Two biosimilar candidates have been licensed out to Santo Holding GmbH.
About bioeq:
bioeq GmbH was established in March 2014 and is funded by the Strüngmann Group (Santo Holding) and by Polpharma, a leading Polish pharmaceutical company. bioeq is active in the development of biosimilars in compliance with standards required for approval and distribution in the EU, US and other highly regulated markets.
Starting from early stage development projects licensed from internationally renowned partners or cell lines stemming from affiliated companies, bioeq conducts development programs up to clinical development and registration. bioeq’s pipeline comprises several of the so-called “third wave” biosimilars, for which patent protection is due to expire within the next decade.
bioeq’s management team combines expert scientists and senior management with a skill set spanning from early stage development through to commercialization of complex molecules and biosimilars.
About biosimilars:
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis and multiple sclerosis. In the coming years, many of these biotech drugs will lose their patent protection – and by 2020, medications with revenues of more than USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. While the global market for biosimilars is currently some USD 2.5 billion, industry experts expect this figure to grow tenfold by the year 2020. In contrast to traditional generic drugs, the development and production of biosimilars is highly complex and requires specialized expertise.
SOURCE: Formycon
Post Views: 375
