Biosimilar portfolio & partnerships

Our proprietary cell line development platform and highly efficient R&D workflows have set the stage for the development of multiple biosimilar candidates.

We have developed an extensive and ever-growing pipeline of biosimilars to treat a number of conditions across major therapeutic areas. Many of these biosimilars have already been partnered, the most advanced of which are listed below.

We consistently invest in the start of one biosimilar development per year based upon expert market analysis, clinical evaluation, and an extensive manufacturing assessment.

The ultimate goal of our biosimilar development is to partner with companies who have the reach to maximize the access to patients who need such high quality medicines.

Our biosimilar pipeline

Ranibizumab FYB201

Lucentis

Ophthalmology

BioEq

Natalizumab PB006

Tysabri

Multiple sclerosis

Sandoz

Vedolizumab PB016

Entyvio

Immunology

Ipilimumab PB008

Yervoy

Oncology

Ocrelizumab PB018

Ocrevus

Multiple sclerosis

Pembrolizumab PB014

Keytruda

Oncology

Nivolumab PB015

Opdivo

Oncology

INN Ranibizumab FYB201

Originator Lucentis

Therapeutic area Ophthalmology

Partner BioEq

Cell line development

Process and formulation development

Clinical development

Submission

INN Natalizumab PB006

Originator Tysabri

Therapeutic area Multiple sclerosis

Partner Sandoz

Cell line development

Process and formulation development

Clinical development

Submission

INN Vedolizumab PB016

Originator Entyvio

Therapeutic area Immunology

Partner -

Cell line development

Process and formulation development

Clinical development

Submission

INN Ipilimumab PB008

Originator Yervoy

Therapeutic area Oncology

Partner -

Cell line development

Process and formulation development

Clinical development

Submission

INN Ocrelizumab PB018

Originator Ocrevus

Therapeutic area Multiple sclerosis

Partner -

Cell line development

Process and formulation development

Clinical development

Submission

INN Pembrolizumab PB014

Originator Keytruda

Therapeutic area Oncology

Partner -

Cell line development

Process and formulation development

Clinical development

Submission

INN Nivolumab PB015

Originator Opdivo

Therapeutic area Oncology

Partner -

Cell line development

Process and formulation development

Clinical development

Submission

Brand name:

Tysabri®

Partner:

Sandoz

Originator:

Natalizumab

Annual sales:

$1.9bn (2019)

Therapeutic area:

Multiple sclerosis

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. Natalizumab was approved by the FDA 2004.

Natalizumab biosimilar PB006

Polpharma Biologics is developing a Natalizumab biosimilar code named PB006. Our partner, Sandoz will commercialize this medicine. Global phase III & phase I PK/PD clinical trials of PB006 both completed recruitment in 2020.

Brand name:

Entyvio®

Partner:

Available

Originator:

Vedolizumab

Annual sales:

$3.2bn (2019)

Therapeutic area:

Immunology

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 will start in 2021.

Brand name:

Lucentis®

Partner:

Bioeq AG

Originator:

Ranibizumab

Annual sales:

$4bn (2019)

Therapeutic area:

Ophthalmology

In addition to the molecules listed above, Polpharma Biologics, through a JV (Bioeq), and in collaboration with Formycon, is working on a Ranibizumab biosimilar, code named FYB201. FYB201 will be commercialized in the US by Coherus.

Ranibizumab biosimilar FYB201

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.

Let’s collaborate and create quality biologics together.

Get in touch for more information.