Polpharma Biologics Moves Forward With Bioceros Integration

Having acquired Dutch company Bioceros and its cell line development platform in 2016, Polish biosimilar manufacturer Polpharma Biologics said absorption of the company’s Netherlands site into its biologics development and manufacturing operations will complete the process of integration. Use of the Bioceros name will be discontinued. Prior to the acquisition, Polpharma was a Biocerus investor.

Polpharma said the change would make it a fully integrated contract and development management organization (CDMO).

State-of-the Art Facility

The company also said it is close to completing development of a state-of-the art, large-scale drug manufacturing plant in Duchnice, near Warsaw. The site will add 4 single-use bioreactor production trains. Clinical and commercial operation is expected to begin in 2021. The facility has been designed for rapid expansion of capacity via the addition of 6 bioreactors.

“The full integration of Bioceros’ capabilities into Polpharma and the additional drug substance capacity soon to be available in Warsaw complements the already significant services we can provide to our clients. We can now support them from concept through development and to clinical and commercial scales,” said Joerg Windisch, CEO of Polpharma Biologics, in a statement.

CDMOs function by serving other companies in the pharmaceutical industry on a contract basis to provide comprehensive drug development and manufacturing services.

Polpharma said the Bioceros proprietary cell line development platform it acquired will help it to develop novel biologics and biosimilars.

Polpharma Biologics’ Biosimilar Pipeline

Polpharma currently has 7 biosimilars in development. Their most advanced candidates include a ranibizumab molecule (FYB201), for which they are nearing the application submission stage, and a natalizumab molecule (PB006), currently in clinical development.

FYB201 is being developed through a partnership with Formycon and a joint venture called Bioeq AG involving Polpharma and the Strüngmann Group. The ranibizumab biosimilar references Lucentis, for the treatment of wet age-related macular degeneration, macular edema, and diabetic retinopathy. FYB201 has finished testing in a phase 3 trial and is being prepared for submission to the FDA and the European Medicines Agency.

PB006 is being developed in partnership with Sandoz. In November 2019, Polpharma began dosing patients with PB006 in a phase 3 clinical trial that is ongoing. Natalizumab is used for the treatment of multiple sclerosis.

Polpharma has ustekinumab (PB007) and vedolizumab (PB016) biosimilars that are both in technical development. The company has 3 other biosimilars in technical development as well (PB008, PB014 and PB015) but has not provided further information to date.