Polpharma Biologics Announces FDA and EMA Acceptance for Review of PB016 Vedolizumab Biosimilar Candidate
Polpharma Biologics International AG today announces that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted for review the Biologics License Application (BLA) and Marketing Authorisation Application (MAA), respectively, for PB016, a proposed vedolizumab biosimilar candidate to Takeda’s reference product Entyvio®* (vedolizumab) lyophilized vial for intravenous (IV) administration for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease.
Teva and Polpharma Biologics Announce Global Licensing Agreement for a Biosimilar Candidate to Ocrevus® (ocrelizumab) for Multiple Sclerosis
Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd (NYSE: and TASE: TEVA) and Polpharma Biologics International AG today announced a global licensing agreement granting Teva exclusive rights to commercialize both formulations of Polpharma Biologics’ proposed biosimilar to Ocrevus®1 (ocrelizumab), upon regulatory approval. This strategic agreement is expected to combine Polpharma Biologics’ proven biosimilar development expertise with Teva’s commercial footprint and capabilities.
