Biosimilar pipeline
Polpharma Biologics has its own pipeline of biosimilars for out- licensing. We are focused on advancing and expanding our product portfolio to increase patient access to these much-needed therapies and are open to partnering with other organizations to co-develop or commercialize our biosimilars.
8+
biologics in the pipeline
3
Development & manufacturing facilities
Bioreactor production capacity
People employed
Polish scientists returned from abroad
We care
our driving value for what we do
Polpharma Biologics has developed and partnered an expanding pipeline of biosimilars to treat a number of conditions across major therapeutic areas. Our proprietary cell line development platform, highly efficient process development as well as extensive manufacturing capabilities have allowed us to rapidly expand our pipeline.
We are highly focused on advancing and expanding our product portfolio and are continually evaluating potential biosimilars. To increase the patient access to these much-needed therapies we actively seek to partner with other organisations to co-develop or commercialize our biosimilars.
Our Biosimilar Pipeline
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Ranibizumab (trade name Lucentis® among others) is a monoclonal anti-angiogenic antibody fragment (Fab) that has been approved to treat the “wet” type of age-related macular degeneration a common form of age-related vision loss. In 2019, Lucentis® generated global sales of more than USD 3.9 billion, with revenue growth continuing at a significant rate. Ranibizumab inhibits angiogenesis by inhibiting vascular endothelial growth factor A.
Ranibizumab biosimilar FYB201
Polpharma Biologics’ joint venture company, Bioeq, in collaboration with Formycon, is working on a Ranibizumab biosimilar, code named FYB201. FYB201 will be commercialized in the US by Coherus and by Teva Pharmaceutical Industries in Europe, Canada, Israel and New Zealand. Bioeq submitted a biologics license application (BLA) for Ranibizumab to the U.S. Food and Drug Administration in August 2021.
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Natalizumab, sold under the brand name Tysabri® among others, is a medication used to treat multiple sclerosis and Crohn’s disease. It is a monoclonal antibody which targets a protein called α4β1 integrin on white blood cells involved in inflammation. By attaching to integrin, natalizumab is thought to stop white blood cells from entering the brain and spinal cord tissue, thereby reducing inflammation and the resulting nerve damage. It was approved by the FDA in 2004 before briefly being removed from the market, it was reintroduced in 2006 when it was also approved for use in the EU.
Natalizumab biosimilar PB006
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Vedolizumab, sold under the brand name Entyvio® is a monoclonal antibody developed by Millennium Pharmaceuticals, Inc (a subsidiary of Takeda Pharmaceuticals) for the treatment of ulcerative colitis and Crohn’s disease. It binds to integrin α4β7. Blocking the α4β7 integrin results in gut-selective anti-inflammatory activity.
Vedolizumab biosimilar PB016
Polpharma Biologics is developing a Vedolizumab biosimilar PB016. Following technical proof of similarity and scale up, GMP production started in 2021. We are actively seeking partners interested in marketing or licensing this biosimilar.
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Ocrelizumab, sold under the brand name Ocrevus®, is used in the treatment of multiple sclerosis (MS). It was approved for use by the FDA in 2017 for primary progressive forms of MS (PPMS) and for use in the European Union in 2018. It is a monoclonal antibody that targets CD20. CD20 is found on B lymphocytes, and as such Ocrelizumab is an immunosuppressive. This helps prevent B cell induced damage to myelin surrounding nerves prevalent in MS patients.
Ocrelizumab biosimilar PB018
Polpharma Biologics is developing a Ocrelizumab biosimilar under code name PB018. We are currently in the process of transferring the cell line and clone to our Gdansk facility to take it to the next stage of technical proof of similarity. We are seeking partners interested in marketing or licensing this biosimilar.
Project:
Partner:
Originator:
Originator annual sales:
Therapeutic Area:
Ranibizumab (trade name Lucentis® among others) is a monoclonal anti-angiogenic antibody fragment (Fab) that has been approved to treat the “wet” type of age-related macular degeneration a common form of age-related vision loss. In 2019, Lucentis® generated global sales of more than USD 3.9 billion, with revenue growth continuing at a significant rate. Ranibizumab inhibits angiogenesis by inhibiting vascular endothelial growth factor A.
Ranibizumab biosimilar FYB201
Polpharma Biologics’ joint venture company, Bioeq, in collaboration with Formycon, is working on a Ranibizumab biosimilar, code named FYB201. FYB201 will be commercialized in the US by Coherus and by Teva Pharmaceutical Industries in Europe, Canada, Israel and New Zealand. Bioeq submitted a biologics license application (BLA) for Ranibizumab to the U.S. Food and Drug Administration in August 2021.
Project:
Partner:
Originator:
Originator annual sales:
Therapeutic Area:
Natalizumab, sold under the brand name Tysabri® among others, is a medication used to treat multiple sclerosis and Crohn’s disease. It is a monoclonal antibody which targets a protein called α4β1 integrin on white blood cells involved in inflammation. By attaching to integrin, natalizumab is thought to stop white blood cells from entering the brain and spinal cord tissue, thereby reducing inflammation and the resulting nerve damage. It was approved by the FDA in 2004 before briefly being removed from the market, it was reintroduced in 2006 when it was also approved for use in the EU.
Natalizumab biosimilar PB006
Project:
Partner:
Originator:
Originator annual sales:
Therapeutic Area:
Vedolizumab, sold under the brand name Entyvio® is a monoclonal antibody developed by Millennium Pharmaceuticals, Inc (a subsidiary of Takeda Pharmaceuticals) for the treatment of ulcerative colitis and Crohn’s disease. It binds to integrin α4β7. Blocking the α4β7 integrin results in gut-selective anti-inflammatory activity.
Vedolizumab biosimilar PB016
Polpharma Biologics is developing a Vedolizumab biosimilar PB016. Following technical proof of similarity and scale up, GMP production started in 2021. We are actively seeking partners interested in marketing or licensing this biosimilar.
Project:
Partner:
Originator:
Originator annual sales:
Therapeutic Area:
Ocrelizumab, sold under the brand name Ocrevus®, is used in the treatment of multiple sclerosis (MS). It was approved for use by the FDA in 2017 for primary progressive forms of MS (PPMS) and for use in the European Union in 2018. It is a monoclonal antibody that targets CD20. CD20 is found on B lymphocytes, and as such Ocrelizumab is an immunosuppressive. This helps prevent B cell induced damage to myelin surrounding nerves prevalent in MS patients.
Ocrelizumab biosimilar PB018
Polpharma Biologics is developing a Ocrelizumab biosimilar under code name PB018. We are currently in the process of transferring the cell line and clone to our Gdansk facility to take it to the next stage of technical proof of similarity. We are seeking partners interested in marketing or licensing this biosimilar.