Lucentis® biosimiliar Ranivisio® (ranibizumab) approved as a new treatment for debilitating retinopathies in Brazil
Amsterdam, Munich – Polpharma Biologics Group BV (“Polpharma Biologics”) and Bioeq AG (“Bioeq”) jointly announce that the Brazilian Health Regulatory Agency (ANVISA) has approved Ranivisio®* (ranibizumab) as a biosimilar to Lucentis®** for the treatment of debilitating retinopathies in Brazil.1 Ranivisio®, developed by Bioeq (a Joint Venture between Polpharma Biologics and Formycon AG) will be exclusively […]
Polpharma Biologics’ investigational biosimilar shows PK/PD comparability to inflammatory bowel disease blockbuster Entyvio®*
Polpharma Biologics, an international biotech company dedicated to the development and manufacturing of biosimilars,…
European Commission approves FYB201/Ranivisio®1 (Ranivisio – Ranibizumab), a biosimilar to Lucentis®2
Amsterdam Munich, Zug – Polpharma Biologics Group BV (“Polpharma Biologics”), Formycon AG (“Formycon”) and Bioeq AG (…
Polpharma Biologics announces FDA file acceptance for review of natalizumab, first proposed biosimilar to Tysabri®
Polpharma Biologics announced today that the U.S. Food and Drug Administration (FDA) has accepted the first-ever Biol…
Polpharma Biologics announces EMA acceptance of Marketing Authorization Application for proposed biosimilar natalizumab
Warszawa, 18 lipca 2022 r. Polpharma Biologics, polska firma biotechnologiczna zajmująca się rozwojem i produkcją leków biologicznych ogłosiła, że Europejska Agencja Leków (European Medicines Agency – EMA) przyjęła wniosek (Marketing Authorization Application – MAA) o wydanie pozwolenia na dopuszczenie do obrotu na terenie Unii Europejskiej – leku biopodobnego zawierającego przeciwciało monoklonalne natalizumab1. Lek jest stosowany […]
MHRA’s authorization for BIOEQ’s biosimilar in the United Kingdom.
MHRA’s authorization for BIOEQ’s biosimilar in the United Kingdom.
We are pleased to share last week’s news on the approval of the marketing authorization application of BIOEQ’s Lucent…
Polpharma Biologics Group announces that its joint venture company, Bioeq, has entered into a commercialization agreement for biosimilar Ranibizumab
The reference product is a monoclonal anti-angiogenic antibody fragment (Fab) that has been approved to treat the “we…
Bioeq, the Polpharma Biologics Group joint venture company and MS Pharma sign exclusive agreement for Ranibizumab in MENA
Zug, Switzerland – MS Pharma has signed an exclusive licensing and supply agreement with Bioeq AG, Switzerland, the P…
Polpharma Biologics Group announces that the Biologics License Application (BLA) submitted by its joint venture Bioeq for its biosimilar Ranibizumab has been accepted for review by the U.S. Food and Drug Administration (FDA)
Bioeq has received notification by the U.S. Food and Drug Administration (FDA) that the biologics license application…
Rapid growth of Polish biotechnology sector leads to demand for foreign expertise, as Polpharma Biologics announces 70 new vacancies
The new roles come on top of significant growth at the company in the last two years, with an additional 300 employee…